{"jobs":[{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7614930003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5712089003,"location":{"name":"Princeton, New Jersey"},"metadata":null,"id":7614930003,"updated_at":"2026-04-10T06:52:10-04:00","requisition_id":"1309","title":"Associate Director, Clinical Quality Management","company_name":"Kyowa Kirin North America","first_published":"2026-02-02T20:12:51-05:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Associate Director, Clinical Quality Management serves as the central Risk-Based Quality Management (RBQM) Lead for Clinical Operations, responsible for enterprise-wide, proactive risk management across clinical trials.\u0026amp;nbsp;This role owns the end-to-end RBQM framework, including risk identification, assessment, mitigation, centralized monitoring, lessons learned, and maintenance of a clinical risk library, ensuring risks are managed consistently and intelligently across studies, programs, vendors, and regions.\u0026amp;nbsp;The role partners cross-functionally to embed risk-based decision-making into study design, execution, oversight, and continuous improvement, in alignment with ICH E6 (R3), GCP, and global regulatory expectations.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Risk-Based Quality Management (RBQM) Leadership\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Lead the design, implementation, and continuous evolution of a holistic RBQM framework across Clinical Operations, aligned with ICH E6 (R3) and regulatory guidance.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Serve as the central RBQM authority ensuring consistent risk management approaches across trials, programs, regions, and vendors.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Integrate RBQM principles into study planning, execution, oversight, and close-out activities.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide expert oversight and guidance to study teams on study-level RBQM plans, ensuring alignment with enterprise risk strategy.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Central Risk Identification, Monitoring \u0026amp;amp; Mitigation\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Lead proactive, cross-study and cross-functional risk assessments to identify systemic, emerging, and study-specific risks.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Define, standardize, and maintain Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs) across trials.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Oversee centralized risk monitoring and trending to enable early detection of critical risks.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Partner with study teams to develop and oversee risk mitigation, contingency, and escalation plans, ensuring inspection Lessons\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Learned \u0026amp;amp; Risk Library Management (Core Ownership)\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Establish and maintain a centralized Clinical Risk Library, capturing:\u0026lt;br\u0026gt;o \u0026amp;nbsp; \u0026amp;nbsp;Known and emerging risks\u0026lt;br\u0026gt;o \u0026amp;nbsp; \u0026amp;nbsp;Root causes\u0026lt;br\u0026gt;o \u0026amp;nbsp; \u0026amp;nbsp;Mitigation strategies\u0026lt;br\u0026gt;o \u0026amp;nbsp; \u0026amp;nbsp;Effectiveness of controls\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Lead lessons learned activities across trials, audits, inspections, and CAPAs.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure lessons learned are:\u0026lt;br\u0026gt;o \u0026amp;nbsp; \u0026amp;nbsp;Systematically captured\u0026lt;br\u0026gt;o \u0026amp;nbsp; \u0026amp;nbsp;Analyzed for trends\u0026lt;br\u0026gt;o \u0026amp;nbsp; \u0026amp;nbsp;Fed back into RBQM planning, SOPs, training, and future studies\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Drive organizational learning by translating lessons learned into preventive, forward-looking risk controls.readiness.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Quality Oversight \u0026amp;amp; Regulatory Compliance\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure clinical trial conduct complies with GCP, regulatory requirements, and company SOPs.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide centralized quality oversight across trials, CROs, and vendors.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support audit and inspection readiness activities, including:\u0026lt;br\u0026gt;o \u0026amp;nbsp; \u0026amp;nbsp;Risk-based inspection preparation\u0026lt;br\u0026gt;o \u0026amp;nbsp; \u0026amp;nbsp;Impact assessments\u0026lt;br\u0026gt;o \u0026amp;nbsp; \u0026amp;nbsp;CAPA development and effectiveness checks\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Vendor \u0026amp;amp; CRO Risk Oversight\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Design and implement risk-based oversight strategies for CROs and external vendors.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Monitor vendor performance using quality metrics and risk indicators.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Lead or support quality governance discussions with external partners.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure vendor-related risks are integrated into the central risk library and lessons learned framework.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Data-Driven Quality \u0026amp;amp; Continuous Improvement\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Leverage data analytics and centralized monitoring tools to enable real-time risk detection and decision-making.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Generate enterprise-level risk trend reports and insights for senior leadership.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Continuously refine RBQM methodologies based on data, inspection outcomes, and lessons learned.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Champion a culture of proactive quality and continuous improvement across Clinical Operations.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Cross-Functional Collaboration \u0026amp;amp; RBQM Expertise\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Act as the RBQM Subject Matter Expert (SME) for Clinical Operations and Clinical Quality Compliance.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide RBQM training and coaching to study teams and cross-functional stakeholders.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate closely with Regulatory, Biostatistics, Data Science, QA, and Vendor Management teams to align risk strategies and metrics.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Participate as an observing member on assigned study teams to provide real-time quality and risk support.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;SOP Management \u0026amp;amp; Governance Support\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Partner with Document Control and SOP Administration teams to ensure RBQM and lessons learned are reflected in SOPs, WIs, and templates.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support governance activities, senior management reporting, and quality metrics standardization.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Recommend and support implementation of corrective and preventive actions to protect system, process, and data integrity.provide real-time quality and risk support.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Education\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Public Health, or related field (required)\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Advanced degree in Clinical Research, Quality Management, Regulatory Affairs, or Data Science (preferred)\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Experience\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;10+ years of experience in Clinical Operations, Clinical Quality, RBQM, or RBM\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Demonstrated experience leading enterprise or cross-study risk management frameworks\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Strong background in audit/inspection readiness, CAPA management, and vendor oversight\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Deep knowledge of ICH-GCP, FDA, EMA, and global regulatory requirements\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Technical Skills\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Expertise with RBQM tools, centralized monitoring systems, and risk analytics\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience defining and using KRIs, QTLs, and quality metrics\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Familiarity with CTMS, eTMF, and data visualization tools (Spotfire, Tableau, Power BI)\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Exposure to AI or predictive analytics for quality monitoring (preferred)\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Working Conditions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Requires up to 25% domestic and international travel. May involve working outside of regular business hours to accommodate global time zones and project deadlines.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be\u0026amp;nbsp;\u0026lt;strong\u0026gt;$175,000 to $190,000.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company match\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Services\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-TT1 #Hybrid #Princeton\u0026lt;/p\u0026gt;","departments":[{"id":4017379003,"name":"Clinical Operations","child_ids":[],"parent_id":null}],"offices":[{"id":4010013003,"name":"Princeton","location":"Princeton, New Jersey, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7635944003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5720463003,"location":{"name":"Princeton, New Jersey"},"metadata":null,"id":7635944003,"updated_at":"2026-03-20T08:22:19-04:00","requisition_id":"1339","title":"Associate Director, ERP Functional \u0026 Solutions Architect- D365","company_name":"Kyowa Kirin North America","first_published":"2026-02-18T13:58:55-05:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Associate Director, ERP Functional \u0026amp;amp; Solution Architect, ICT role will be responsible for overseeing MS D365 Enterprise Resource Planning (ERP) within the organization. Crucial role in implementing ERP specific business process improvements and enhancements within the organization and ensuring the system\u0026#39;s optimal performance and functionality. Perform the planning, design, configuration, customization, and implementation of MS D365/ERP modules and functionalities, ensuring seamless integration with existing systems, ensuring compliance with industry standards, security protocols, and regulatory requirements. The ERP Functional Architect, Associate Director, ICT role will also serve as a business process analyst aligned with enterprise (i.e., SCM, MFG, Quality) and Corporate Functions (i.e., Finance, HR, Legal, Compliance, Procurement) ensuring successful technical solution development and delivery.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The D365 ERP F\u0026amp;amp;O Functional Architect is responsible for the end-to-end functional design, configuration, and optimization of Microsoft Dynamics 365 Finance \u0026amp;amp; Operations to support business operations across Finance, Procurement, Supply Chain, Manufacturing, Quality, and related business functions. The architect will partner with business stakeholders, technical teams, and implementation partners to ensure that the solution is aligned with corporate strategy, compliant with GxP/GAMP 5 standards (where applicable), and scalable for future business growth.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;1. Solution Architecture \u0026amp;amp; Design\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Lead the functional design and architecture of the D365 F\u0026amp;amp;O solution across key modules (Finance, Supply Chain, Manufacturing, Procurement, Inventory, Quality, etc.).\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Translate complex business requirements into clear, scalable, and compliant functional solutions.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Emphasizes proactive, holistic leadership in solution architecture.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Focuses on aligning solutions with business goals, value streams, and enterprise architecture governance.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Define data flows, integrations, and system interactions between D365 and other enterprise systems \u0026amp;amp; interfaces (e.g., LIMS, MES, 3PL Partners, External Finance Systems, and Cloud systems).\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure alignment with Microsoft’s Dynamics 365 roadmap and best practices.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;2. Implementation \u0026amp;amp; Configuration\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Perform and lead the setup, configuration, and deployment of D365 F\u0026amp;amp;O modules.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;End to end management of project/solution management by using tools like Azure Boards for planning and tracking work, Azure Repos for code versioning, and Azure Pipelines for automating build and deployment. Perform all activities from initial user stories and tasks to code, testing, and deployment through integrations with tools like Lifecycle Services (LCS).\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Drive fit-gap analysis and functional documentation. Develop User/Functional Requirements, Functional/Technical Design, System/Business process architecture diagrams.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate with development/vendor/managed service teams to define functional specifications for enhancements, bug/fix, customizations, reports, and interfaces. Co-develop or individually develop code/configurations required and coordinate internal development and user acceptance testing of the solution.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Participate in system validation activities, including IQ/OQ/PQ documentation for regulated environments.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;3. Governance \u0026amp;amp; Compliance\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure the ERP system design complies with GAMP 5, SOX, and GxP regulatory requirements.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Develop and maintain master data governance, change management, and configuration control processes.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support audits and inspections through proper documentation and traceability.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Develop current and future state roadmaps and architecture.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Assess and align system release plan with Microsoft Dynamics 365 roadmap\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;4. Stakeholder Collaboration\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Partner with business process owners to define best practices, continuous improvement opportunities, and confirm desired solution to fix the support/bug-fix items raised. Support communities of practice and collaborative development methodology.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Work independently to perform required fix within the D365 framework. Test and confirm the developed fix with business process owners.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Work closely with IT, OT, and cloud teams to ensure integrated digital architecture.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide subject matter expertise and training for internal business process owners and super users.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;5. Project \u0026amp;amp; Vendor Management\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support ERP implementation and upgrade projects through all phases — initiation, design, testing, go-live, and hypercare.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Manage and coordinate external implementation partners and vendors.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Define KPIs and monitor system performance, adoption, and ROI.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Education\u0026amp;nbsp;\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Bachelor’s degree or equivalent experience in computer science, information systems, engineering, supply chain, or related fields required. Microsoft D365 F\u0026amp;amp;O Certification preferred.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Experience\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;8+ years of experience implementing or supporting Microsoft Dynamics AX / D365 F\u0026amp;amp;O.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proven expertise across multiple functional domains (Finance, Manufacturing, Supply Chain, Procurement).\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience designing integrations between ERP and external systems (LIMS, MES, Payment interface with Bank, External Finance Systems, etc.).\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Strong understanding of ERP data models, workflows, and reporting.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Strong understanding of functional and solution architecture of, and experience performing code and configuration updates within the following Dynamics 365 modules:\u0026lt;br\u0026gt;o \u0026amp;nbsp; \u0026amp;nbsp;Finance: General ledger, Cash and bank management, Accounts payable, Accounts receivable. Budgeting, Fixed assets, Cost accounting, PR/PO process, Vendor Management, Cost Accounting and Management\u0026amp;nbsp;\u0026lt;br\u0026gt;o \u0026amp;nbsp; \u0026amp;nbsp;SCM: Inventory management, Master planning, Procurement and sourcing, Product information management, Production control, Warehouse management, Cost accounting, Cost management, Asset management, including scheduled maintenance and repair tasks\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Technical Skills\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proficient in MS Office Suite. Experience with technology delivery applications across solutions such as (ERP, Manufacturing Execution Systems, Finance Systems, Control Tower).\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Microsoft Certified: Dynamics 365: Finance and Operations Apps Solution Architect Expert certification preferred.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience with emerging technologies (AI/ML, cloud, etc.) as relevant to ERP.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Working Conditions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Requires up to 10 % domestic and international travel\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be \u0026lt;strong\u0026gt;$165,000 to $190,000.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company match\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Services\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-TT1 #Hybrid #Princeton\u0026lt;/p\u0026gt;","departments":[{"id":4017385003,"name":"Information Technology","child_ids":[],"parent_id":null}],"offices":[{"id":4010013003,"name":"Princeton","location":"Princeton, New Jersey, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7635861003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5720425003,"location":{"name":"Princeton, New Jersey"},"metadata":null,"id":7635861003,"updated_at":"2026-03-20T08:22:19-04:00","requisition_id":"1337","title":"Associate Director, Regulatory Affairs Advertising \u0026 Promotion Compliance","company_name":"Kyowa Kirin North America","first_published":"2026-02-18T14:00:03-05:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Associate Director, Regulatory Affairs, Advertising and Promotion Compliance will independently review, approve, and monitor product advertising and promotional labeling material for an assigned product to ensure compliance with US regulatory requirements. \u0026amp;nbsp;In addition, the associate director will be responsible for supporting preparation of FDA Form 2253 submissions and any requests for advisory comment submissions to FDA\u0026#39;s Office of Prescription Drug Promotion (OPDP) as well as submissions to PAAB for promotional materials in Canada, as applicable.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;The Associate Director is responsible for providing strategic and tactical regulatory support and guidance for assigned product and disease state communications as well as pipeline and non-promotional communications.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provides guidance and input for assigned development products reflective of promotional considerations, including assessment of potential labeling claims.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Serves as Promotional Review Committee (PRC) chair and as the primary regulatory reviewer of advertising, promotions, and other related materials for assigned product to ensure compliance with applicable FDA/Health Canada laws, regulations, and guidance. \u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Works collaboratively with cross-functional partners, including Legal and Medical as part of PRC. Develops solutions to complex promotional issues by utilizing scientific and regulatory knowledge to support business objectives and initiatives while effectively identifying, escalating, and managing business risks. \u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Serves as the regulatory reviewer for the Medical Review Process (MRC) for assigned product(s).\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provides direction and works collaboratively to ensure that changes in US Prescribing Information and Canadian Product Monograph are reflected in current promotions and advertising\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Continually assesses the advertising and promotion related\u0026lt;br\u0026gt;process to enhance efficiencies and compliance.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborates in cross-functional efforts to develop, update, and implement policies, procedures and guidelines related to Regulatory Advertising and Promotion Compliance.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Primary liaison with Office of Prescription Drug Promotion (OPDP) regarding advertising and promotion for assigned products.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Monitors US and Canadian regulatory promotional environment and stays abreast of all relevant regulatory and industry changes and updates related to FDA and Health Canada guidance, warning letters, enforcement actions and regulations; and communicate to appropriate internal and external personnel in a timely manner, highlighting the implications of the changes\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensures the maintenance of paper and electronic records of all submissions and communications with OPDP, and any supporting documentation\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide relevant regulatory compliance training to staff and cross-functional partners from a regulatory perspective.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Education\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;Bachelor’s degree in life science or closely related discipline. Advance degree preferred (Pharm.D., Phd, M.S, JD)\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Experience\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Minimum seven (7) years of progressive experience in the pharmaceutical or biotechnology industry, specifically in Regulatory Affairs with a focus on Advertising and Promotion (Ad/Promo).\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proven track record as the primary regulatory reviewer for promotional and non-promotional materials across various therapeutic areas, ensuring compliance with FDA regulations, industry guidelines (e.g., OPDP, PhRMA), and internal policies.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Strong experience in leading and managing Regulatory review processes within cross-functional Medical, Legal, and Regulatory (MLR) teams for both consumer and professional marketing materials.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Familiarity with launch planning, including pre-approval communications, disease awareness campaigns, and launch materials.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience with training Commercial and cross-functional teams on promotional compliance principles, regulatory changes, and industry best practices.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Preferred, but not required, experience with reviewing promotional and non-promotional communications in Canada to be compliant with Health Canada regulations.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Technical Skills\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Thorough knowledge of applicable regulations, guidance, and industry standards related to advertising and promotional communications about prescription drugs, devices (if applicable), and investigational treatments in the US\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Understanding of clinical study design and statistical analyses in assessment of promotional claims\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Excellent written, verbal, and presentation skills, with the ability to communicate effectively across all levels of the organization.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Solid proficiency using Microsoft Office Suite including Word, Excel, and Power Point for documentation, analysis, and presentations.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience with Veeva, SharePoint and Box\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Working Conditions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Requires up to 10% domestic and international travel\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be\u0026amp;nbsp;\u0026lt;strong\u0026gt;$____ to $____.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company match\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Services\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-TT1 #Hybrid #Princeton\u0026lt;/p\u0026gt;","departments":[{"id":4017397003,"name":"Regulatory Affairs","child_ids":[],"parent_id":null}],"offices":[{"id":4010013003,"name":"Princeton","location":"Princeton, New Jersey, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7649331003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5725701003,"location":{"name":"Princeton, New Jersey"},"metadata":null,"id":7649331003,"updated_at":"2026-04-20T21:01:14-04:00","requisition_id":"1354","title":"Associate Director, Site Budget Management","company_name":"Kyowa Kirin North America","first_published":"2026-03-02T13:30:23-05:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Associate Director, Site Budget Management provides strategic and operational leadership across assigned segments of Kyowa Kirin’s global clinical study portfolio. This role bridges study-level execution and enterprise strategy by overseeing budget governance, forecasting methodology, financial risk management, and process optimization initiatives.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Associate Director drives consistency in budget development, negotiation parameters, and payment oversight while contributing to short and mid-range portfolio planning. This position ensures financial integrity, scalability, and alignment with global FMV standards across all new and ongoing studies within scope.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Portfolio Oversight and Financial Planning\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide oversight across multiple global studies within assigned therapeutic areas or portfolio segments.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Partner with the Director to support long range financial planning across the clinical pipeline.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Review and validate study-level forecasts to ensure portfolio alignment.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Identify cross-study cost trends, variance drivers, and financial risk indicators.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support accrual accuracy and forecast predictability.\u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026lt;em\u0026gt;Global Budget Governance and FMV Oversight\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure consistent application of FMV methodology across assigned studies.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Validate high, mid, and low negotiation parameters.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Review CRO-developed budgets for compliance and alignment to governance standards.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support regional alignment including US, EU, and Japan point system methodologies.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Maintain audit-ready documentation and financial traceability.\u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;em\u0026gt;Budget Development and Negotiation Leadership\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Oversee study-level budget build, review, and approval processes.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide negotiation strategy guidance to Senior Managers and CRO analysts.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Escalate deviations outside approved financial thresholds.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure budget alignment with protocol scope and operational effort.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Review amendment-related financial impacts.\u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026lt;em\u0026gt;Process Optimization and Standardization\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Identify opportunities to improve global budget workflows.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Standardize templates, parameter frameworks, and tracking tools.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Reduce negotiation cycle times through structured governance.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Contribute to automation and systems integration initiatives.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Develop KPIs to measure performance, cycle time, and cost containment.\u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;em\u0026gt;Site Payment and Vendor Oversight\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide financial oversight of site payment execution across assigned portfolio.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Monitor vendor and CRO payment performance.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Review reconciliation reporting and identify discrepancies.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Serve as escalation point for complex payment-related issues.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure payment schedules align with approved budgets and contractual terms.\u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;em\u0026gt;Financial Analytics and Executive Reporting\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Prepare consolidated financial dashboards for assigned portfolio segment.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide variance analysis and risk summaries.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support executive reporting with clear financial narratives.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Conduct scenario modeling to evaluate financial impact of amendments, enrollment changes, or country mix adjustments.\u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026amp;nbsp;\u0026lt;em\u0026gt;Leadership and Organizational Support\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Directly manage Site Budget Managers and Senior Managers as assigned.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide strategic oversight to CRO budget analysts within outsourced model.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Mentor team members on forecasting discipline and governance expectations.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support resource demand planning based on study complexity and portfolio growth.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Education\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;Bachelor’s degree in finance, Business Administration, Accounting, Life Sciences, or related discipline required.\u0026lt;br\u0026gt;Advanced degree or professional certification preferred\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Experience\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Minimum seven (7) years of experience in clinical trial budgeting, site financial management, or global clinical business operations.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Demonstrated experience managing global site budgets.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience within an outsourced CRO operating model.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience supporting portfolio forecasting and financial analytics.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience leading or mentoring budget professionals.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Working knowledge of Japan FMV methodology preferred.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Technical Skills\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Advanced Excel and financial modeling capability.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Expertise in FMV benchmarking tools.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience with GrantPlan or equivalent systems.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Familiarity with CTMS, reporting platforms, and payment tracking systems.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Strong analytical and risk assessment capability.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Core Competencies\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Strategic thinking with operational execution strength\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Financial governance discipline\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Process improvement mindset\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Executive communication capability\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Risk identification and mitigation\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Structured decision making\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Cross-functional collaboration\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;High integrity and compliance orientation\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Working Conditions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Requires up to 10%-15% domestic and international travel\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Availability to support global teams across multiple time zones, including periodic late evening calls.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be \u0026lt;strong\u0026gt;$175,000 to $205,000.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company match\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Services\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-TT1 #Remote #Princeton\u0026lt;/p\u0026gt;","departments":[{"id":4017379003,"name":"Clinical Operations","child_ids":[],"parent_id":null}],"offices":[{"id":4010013003,"name":"Princeton","location":"Princeton, New Jersey, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7660688003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5730275003,"location":{"name":"Princeton, New Jersey"},"metadata":null,"id":7660688003,"updated_at":"2026-03-20T08:22:19-04:00","requisition_id":"1361","title":"Associate Director, Veeva Vault Architect","company_name":"Kyowa Kirin North America","first_published":"2026-03-11T08:56:04-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Veeva Vault Architect serves as the technical and strategic leader for designing, implementing and optimizing Veeva Vault solutions across the global organization. \u0026amp;nbsp;This role ensures that all Vault applications align with business objectives, regulatory requirements, and enterprise architecture standards. \u0026amp;nbsp;The architect collaborates closely with business stakeholders, IT teams and implementation / support partners to deliver scalable, compliant and high performing Vault-based solutions.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Solution Architecture \u0026amp;amp; Design\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Develop end to end architecture for Veeva Vault applications (e.g., Quality, RIM, Medical, Commercial).\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Interpret business requirements into scalable, secure and compliant Vault configurations.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Define data models, object structures, workflows, lifecycle states and security models.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Establish integration patterns between Vault and other enterprise systems (ERP, LMS, MDM, LIMS, etc.).\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Create architectural standards, design documents and technical specifications.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Platform Leadership\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Serve as the subject matter expert for Veeva Vault capabilities, limitations and best practices.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Guide configuration teams on Vault objects, metadata, workflows and automation.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Familiarity with domain level configuration and best practices.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Evaluate new Vault features and releases, advising on adoption and impact.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure alignment with GxP, 21 CFR Part 11, Annex 11, and other regulatory frameworks.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Implementation \u0026amp;amp; Delivery\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Lead technical workstreams during Vault implementations, migrations and enhancements.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Oversee data migration strategies, mapping, cleansing and validation.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support test planning, execution, and defect resolution for configuration and integrations.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Partner with project managers to ensure delivery timelines and quality standards are met.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Integration \u0026amp;amp; Data Management\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Architect and oversee integrations using native Veeva Vault Integrations, Veeva APIs, Vault Loader and middleware tools across both Vault and other applications.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure adherence to data governance, master data strategies and cross system data flows.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure data integrity, auditability, and traceability across the Vault ecosystem.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Stakeholder Collaboration\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Work with business process owners to understand needs and translate them into technical solutions.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate with QA/SA, Compliance, Data Privacy and Validation teams to ensure system readiness.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide technical guidance to internal teams and external implementation partners.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Operational Excellence\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Establish monitoring, performance optimization and support frameworks.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Develop documentation, SOPs and knowledge transfer materials.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support ongoing enhancements, change requests and continuous improvement initiatives.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Education\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Bachelor’s degree or equivalent experience in computer science, information systems, engineering or related fields required. Veeva Vault certification(s) preferred.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Technical Skills\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;8+ years of experience in the configuration, implementation, support and operations of Veeva Vault-based solutions.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proven expertise across multiple functional domains (Quality, Regulatory, Medical, Commercial and/or Clinical).\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Hands-on experience with Veeva APIs, integration patterns and data migration tools.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Knowledge of GxP compliance, validation practices and regulated system requirements.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience with large-scale, global implementations.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience with middleware platforms (e.g., MuleSoft, Informatica), Master Data Management concepts and solutions preferred.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Working Conditions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Requires up to 10 % domestic and international travel.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Willingness to work in a global environment with the ability to adapt to diverse cultural norms, including different communication styles, time zones, holiday schedules, and management approaches.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be \u0026lt;strong\u0026gt;$185,000 to $200,000.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company match\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Services\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-TT1 #Hybrid #Princeton\u0026lt;/p\u0026gt;","departments":[{"id":4017385003,"name":"Information Technology","child_ids":[],"parent_id":null}],"offices":[{"id":4010013003,"name":"Princeton","location":"Princeton, New Jersey, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7687927003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5744320003,"location":{"name":"Princeton, New Jersey"},"metadata":null,"id":7687927003,"updated_at":"2026-06-03T14:14:07-04:00","requisition_id":"1382","title":"Director, Clinical Science (non-hemato-oncology)","company_name":"Kyowa Kirin North America","first_published":"2026-04-02T13:26:48-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director, Clinical Science (non-hemato-oncology) is a vital position in our growing global organization. As part of the Clinical Science group, this person is a key member of multi-disciplinary project teams responsible for the achievement of milestones (e.g., IND, FIH, POC, EOP2, NDA) for development programs. It is expected for this role to exercise leadership in the scientific discussion in project teams from the clinical perspective, diving deeply into the science of her/his assigned program(s), and perform the role of a subject matter expert for the program(s). He/she will play an active role in the creation of regulatory documents (e.g., BB, IND), study protocols, and clinical development plans for new and/or launched products, including lifecycle management. \u0026amp;nbsp;He/she will be responsible for establishing and maintaining KOL relationships.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Serve as leading voice on clinical matters as Clinical Science representative on assigned project team(s), based on firm understanding of given disease area(s) and of clinical development processes, especially in the US and Europe\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Lead in the formulation of clinical development strategies, in collaboration with related functions, and create clinical development plans, accordingly\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Lead in the formulation of clinical trial protocols with sufficient feasibility and high probability of success, based on significant expertise in new drug development\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Lead in the development of written material for clinical sections of key regulatory submissions; work closely with Regulatory in the process of preparing these submissions and ensure compliance with local regulatory requirements and standards throughout the course of clinical trials.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Work closely with cross-functional teams, including Regulatory, Marketing, and Quality to support clinical trial design and execution, regulatory submissions, and launch-related activities.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide input from the clinical perspective to the formulation of Target Product Profiles.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Analyze safety and efficacy findings from clinical studies; participate in inter-disciplinary team meetings, as required\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support required safety evaluations for clinical studies, e.g. AE assessment, as needed.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Create and maintain good relationships with clinical investigators and relevant Key Opinion Leaders; identify physicians with potential to serve as strong investigators for clinical studies\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Attend relevant scientific meetings to strengthen competency in assigned field(s) and to gain awareness of research activities underway and activities of competitors\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Serve as an author and lead in the preparation of review articles and conference presentations, relating to assigned clinical trial(s)\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support business development, as needed, in due diligence efforts of new in-licensing opportunities (or other topics).\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Foster and contribute to collaborative environment that seeks to encourage innovation, strengthen scientific understanding among team members, and enhance professional development for all.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Perform other duties, as required.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Education\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;MD (or equivalent), PharmD, PhD in life sciences or related field; applicable R\u0026amp;amp;D experience may also be considered.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Experience\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Minimum 10 years of relevant clinical research experience with at least 5 years in clinical development role\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Authorship and review of clinical development plans, clinical study protocols, briefing books, IBs, SAPs, and CSRs\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Significant experience and ability to work effectively with external partners, including physicians and vendors\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Preferred experience: leadership role in large, late-stage, global outcomes trials; background in Bone \u0026amp;amp; Mineral or Rare Disease trials\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Technical Skills\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Strong scientific background with good understanding of drug development process\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Good leadership skills, highly motivated, great attention to detail, ability to work in complex and changing situations, excellent problem-solving skills\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Broad level of interpersonal skills and flexibility; cultural sensitivity and ability to develop consensus within matrix structure of a multinational organization\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Excellent written and oral communication skills\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Good project management skills; able to organize and prioritize multiple activities\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proficient in MS Office Suite, relevant software applications, using templates, and other electronic formats\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ability to think analytically (in terms of both strategy and tactics) and simultaneously consider scientific, medical, and business aspects of projects\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Working Conditions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Requires up to 15% domestic and international travel\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be \u0026lt;strong\u0026gt;$225,000 to $285,000.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company match\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Services\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-TT1 #Hybrid #Princeton\u0026lt;/p\u0026gt;","departments":[{"id":4065616003,"name":"Strategy","child_ids":[],"parent_id":null}],"offices":[{"id":4010013003,"name":"Princeton","location":"Princeton, New Jersey, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7724569003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5760398003,"location":{"name":"Sanford, NC"},"metadata":null,"id":7724569003,"updated_at":"2026-05-05T11:36:17-04:00","requisition_id":"1394","title":"Director, Manufacturing Legal Counsel","company_name":"Kyowa Kirin North America","first_published":"2026-05-05T11:36:17-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a global specialty pharmaceutical company committed to improving the lives of patients. Kyowa Kirin, Inc., the U.S. operating entity, is expanding its North American footprint by building its first U.S. manufacturing facility in Sanford, North Carolina (“Sanford”), a greenfield site currently progressing through the construction phase. As the site moves toward start‑up and future operations, we are seeking a full‑time, embedded attorney to support this critical initiative as it scales from build‑out to steady‑state operations.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary of Job:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Manufacturing Counsel will be a member of the U.S. Kyowa Kirin Legal Department and serve as the primary legal business partner supporting the Sanford manufacturing site, with a focus on contracting and transactional support, while acting as the first point of legal contact for site leadership on regulatory, Human Resources, and operational matters.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;br\u0026gt;This role will provide day‑to‑day legal support—in close collaboration with Legal, Compliance, Quality, and other internal subject‑matter experts—across Sanford‑related contracting and selected regulatory and compliance matters, including activities related to planning, construction, qualification, validation, regulatory submissions, and manufacturing operations.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;br\u0026gt;As an individual contributor, the Manufacturing Counsel will operate as a trusted legal advisor, applying sound judgment, practical risk assessment, and a collaborative, solutions‑oriented approach in a fast‑paced, scaling manufacturing environment.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Reporting relationship:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Senior Director, Senior Corporate Counsel (Princeton, NJ), with dotted-line reporting relationship to the Vice President of Manufacturing (Sanford, NC).\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Contracting \u0026amp;amp; Transactional Support (primary responsibility)\u0026lt;br\u0026gt;•\u0026lt;/strong\u0026gt; Utilize the Legal Department’s contract management system to manage the contracting process for Sanford-related\u0026amp;nbsp;agreements, including review, negotiation, approval, and execution.\u0026lt;br\u0026gt;• Partner with Sanford stakeholders to support the drafting and negotiation of manufacturing, construction, consulting, equipment, supply, and operations related agreements.\u0026lt;br\u0026gt;• Prepare guidance and training materials to support the efficient and compliant use of the Legal Department’s contract management system.\u0026lt;br\u0026gt;• Coordinate the work of paralegals and outside counsel supporting Sanford matters, as needed.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Regulatory \u0026amp;amp; Human Resources Support\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;• Provide practical legal guidance on laws and regulations applicable to pharmaceutical manufacturing operations, including the Food, Drug, and Cosmetic Act. Partner with Princeton-based Legal colleagues and outside counsel, as needed, to address more complex or significant legal matters affecting Sanford operations.\u0026lt;br\u0026gt;• Provide legal support to Human Resources on Sanford-related employment and employee relations matters, in coordination with internal employment counsel and external counsel as appropriate.\u0026lt;br\u0026gt;• Work closely with colleagues from Legal and Compliance to provide consistent and efficient guidance in accordance with Kyowa Kirin’s healthcare compliance policies and related laws and regulations.\u0026lt;br\u0026gt;• Conduct legal research and draft memoranda / provide counsel in response to Sanford-related legal and regulatory inquiries.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Site Leadership \u0026amp;amp; Strategic Cross-Functional Support\u0026lt;br\u0026gt;• \u0026lt;/strong\u0026gt;Serve as a member of the Sanford site Senior Leadership Team and an embedded legal advisor to Sanford business partners by applying sound judgment, practical risk assessment, and a solutions‑oriented approach in a fast‑paced manufacturing and site‑startup environment.\u0026lt;br\u0026gt;• Engage regularly with Sanford site leadership and cross‑functional stakeholders to support alignment on contracting priorities, legal risk considerations, and compliance expectations.\u0026lt;br\u0026gt;• Collaborate with internal functions to support cross‑functional and cross‑border Sanford initiatives.\u0026lt;br\u0026gt;• Support Sanford‑related projects and initiatives that require coordination across functions or regions to ensure alignment with Kyowa Kirin policies and Legal Department practices.\u0026lt;br\u0026gt;• Develop strong working relationships across the organization and operate in alignment with Kyowa Kirin’s global values: Commitment to Life; Innovation; Integrity; and Teamwork / Wa.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Requirements\u0026lt;/strong\u0026gt;:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;• BA/BS required.\u0026lt;br\u0026gt;• Juris Doctorate degree from Accredited Law School is required.\u0026lt;br\u0026gt;• Admission in good standing to at least one U.S. state bar; eligibility for North Carolina in-house registration required.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;br\u0026gt;\u0026lt;strong\u0026gt;Experience\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;• 4–8 years of legal experience, preferably including contracting and legal support for manufacturing, construction, or operations in a regulated industry. Life science experience preferred but not required.\u0026lt;br\u0026gt;• Law firm experience required. In-house experience is a plus.\u0026lt;br\u0026gt;• Experience with cross-functional teams (including ex-US) and demonstrated ability to collaborate effectively with others to address complex legal, compliance, and operational issues is a plus.\u0026lt;br\u0026gt;• Experience in drafting and negotiating contracts such as master services agreements, statements of work, confidentiality agreements, consulting agreements, master purchase agreements, supply agreements, quality/technical agreements, and other corporate pharmaceutical-related and/or manufacturing-related agreements is required.\u0026lt;br\u0026gt;• Experience using contracting management systems (e.g., intake, workflow, approvals, and execution) is a plus.\u0026lt;br\u0026gt;• Must understand contract law and have effective communication and negotiation skills and the ability to influence and work collaboratively at all levels and across functions.\u0026lt;br\u0026gt;• Demonstrated understanding of pharmaceutical manufacturing operations and the related regulatory environment is a plus.\u0026lt;br\u0026gt;• Foundational understanding of employment law or counsel human resources functions is a plus.\u0026lt;br\u0026gt;• Experience supporting a start‑up, greenfield, or rapidly scaling operational environment is a plus.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;br\u0026gt;\u0026lt;strong\u0026gt;Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;Advanced proficiency in MS Office Suite (Word, Excel, Outlook).\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Non-Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives.\u0026lt;br\u0026gt;\u0026lt;br\u0026gt;Comfortable working onsite in a manufacturing and construction environment and engaging directly with operational stakeholders.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.\u0026lt;br\u0026gt;\u0026lt;br\u0026gt;Communicate with care by actively listening and considering others\u0026#39; perspectives, fostering productive, engaging interactions, and managing relationships with kindness.\u0026lt;br\u0026gt;\u0026lt;br\u0026gt;Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Physical Demands:\u0026lt;/strong\u0026gt; The role will initially involve work in an office setting and on an active construction site in Sanford, North Carolina, with a planned transition in 2027 to the fully operational Sanford manufacturing facility.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Working Conditions\u0026lt;/strong\u0026gt;: Requires up to 10% domestic and limited international travel\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be \u0026lt;strong\u0026gt;$227,300 to $270,000.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company matching\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long-Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Service\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-JC1\u0026lt;/p\u0026gt;","departments":[{"id":4017387003,"name":"Legal","child_ids":[],"parent_id":null}],"offices":[{"id":4053087003,"name":"Sanford","location":"Sanford, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7578917003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5696862003,"location":{"name":"Princeton, New Jersey"},"metadata":null,"id":7578917003,"updated_at":"2026-04-24T14:30:10-04:00","requisition_id":"1290","title":"Director of Pharmacometrics- Clinical Pharmacology","company_name":"Kyowa Kirin North America","first_published":"2026-01-06T09:49:22-05:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director of Pharmacometrics will lead a team of Pharmacometricians within the Global Development Organization (GDO) and Clinical Pharmacology (CP) function. The role is intended to have a balance of direct project related activities and to support team members in the development and execution of model informed drug development (MIDD) strategies. The Director of Pharmacometrics will support continued development of appropriate workflows and systems to provide quantitative clinical pharmacology deliverables. The Director of Pharmacometrics will help develop all GDO CP members on communication of MIDD strategies and approaches to project teams. The Director of Pharmacometrics will serve to communicate with and educate leadership across the GDO organization, including those in other GDO Functions, on the value of MIDD and quantitative clinical pharmacology strategies. The Director of Pharmacometrics will also look for innovative ways to work with Kyowa Kirin organizations outside of GDO, including but not limited to Regulatory Affairs and Medical Affairs, to increase MIDD strategies throughout development and in post-marketing space.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Accountable for pharmacometrics deliverables supporting project teams, ensuring scientific quality, timeliness, and impact; identify and drive opportunities to advance quantitative clinical pharmacology across the organization.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Guide pharmacometrics strategy and ensure high-quality preparation of pharmacometric components for scientific reports, regulatory submissions, and responses to health authority inquiries.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide scientific and technical leadership to pharmacometrics staff, ensuring excellence in modeling approaches and effective communication at all organizational levels.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support clear and impactful communication of pharmacometric and clinical pharmacology results to diverse internal and external audiences.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate with GDO Clinical Pharmacology colleagues and cross-functional partners to improve efficiency, alignment, and innovation across drug development initiatives.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Advance Model-Informed Drug Development (MIDD) standards by incorporating best practices from the scientific community to continuously improve workflows, processes, and analytical rigor.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Establish and implement workflows, tools, and training programs, leveraging internal and external resources to strengthen pharmacometrics capabilities within GDO Clinical Pharmacology, with particular focus on developing Pharmacometrics Leads.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Develop and maintain a network of preferred external pharmacometrics experts to support advanced or specialized analyses as needed.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Promote scientific visibility through conference presentations and peer-reviewed publications, ensuring dissemination of insights and research outcomes to the broader scientific community.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Education\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;PhD preferred with specialty training in Pharmacometrics,\u0026amp;nbsp;appropriate MS or PharmD also applicable\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Experience\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Minimum 10 years of pharmaceutical industry experience gained in pharmacometrics / quantitative clinical pharmacology is required.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;The understanding and ability to communicate and apply MIDD strategies to drug development.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Understanding of pharmacometrics contributions for successful clinical development of small molecules, biologics, and alternative therapies.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience in the successful use of MIDD to support drug development decision making\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ability to conduct hands-on modeling and simulation using appropriate quantitative tools in a regulated drug development environment, considered expert in field\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience in the preparation of strategic regulatory documents including reports, summary documents, and response to information requests.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Leadership of a team with various backgrounds and skills in pharmacometrics.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience of developing individuals pharmacometric and communication skills and talents \u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Technical Skills\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;Proficient in MS Office Suite.\u0026lt;br\u0026gt;Demonstrated proficiency with pharmacometric software tools for non-linear mixed effects modeling, data manipulation, physiologically based pharmacology, and systems pharmacology modeling, such as: Julia/Pumas app, R-studio, NONMEM.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be \u0026lt;strong\u0026gt;$230,000 to $250,000.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company match\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Discretionary Profit Share\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Services\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-TT1 #Hybrid #Princeton\u0026lt;/p\u0026gt;","departments":[{"id":4017380003,"name":"Clinical Pharmacology","child_ids":[],"parent_id":null}],"offices":[{"id":4010013003,"name":"Princeton","location":"Princeton, New Jersey, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7761767003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5776323003,"location":{"name":"Field"},"metadata":null,"id":7761767003,"updated_at":"2026-06-03T13:45:14-04:00","requisition_id":"1409","title":"Director, Rare Disease Medical Science Liaison","company_name":"Kyowa Kirin North America","first_published":"2026-06-03T10:51:47-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based\u0026amp;nbsp;company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary of Job\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;447\u0026quot; data-end=\u0026quot;659\u0026quot;\u0026gt;The Director, Rare Disease Medical Science Liaison will be responsible for leading a national team of MSLs in rare disease and acting as a liaison to the medical and scientific community on behalf of Kyowa Kirin.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;661\u0026quot; data-end=\u0026quot;873\u0026quot;\u0026gt;Responsibilities include guiding and assisting MSLs in the identification of and relationship building with medical societies, study groups, Key Opinion Leaders (KOLs), and other Health Care Professionals (HCPs).\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;875\u0026quot; data-end=\u0026quot;1016\u0026quot;\u0026gt;The Director will engage in scientific exchange during field ride-alongs and while attending medical conferences and advisory board meetings.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;1018\u0026quot; data-end=\u0026quot;1220\u0026quot;\u0026gt;The Director may also temporarily cover territories that are vacant due to vacation, illness, FMLA, pregnancy leave, resignation/termination, etc., and perform the functions of the MSL during that time.\u0026lt;/p\u0026gt;\n\u0026lt;hr data-start=\u0026quot;1222\u0026quot; data-end=\u0026quot;1225\u0026quot;\u0026gt;\n\u0026lt;h3 data-section-id=\u0026quot;1peydm1\u0026quot; data-start=\u0026quot;1227\u0026quot; data-end=\u0026quot;1250\u0026quot;\u0026gt;Essential Functions\u0026lt;/h3\u0026gt;\n\u0026lt;p data-start=\u0026quot;1252\u0026quot; data-end=\u0026quot;1343\u0026quot;\u0026gt;\u0026lt;strong data-start=\u0026quot;1252\u0026quot; data-end=\u0026quot;1343\u0026quot;\u0026gt;Acts as a role model to lead the US Medical Science Liaison (MSL) Rare Disease program:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;1345\u0026quot; data-end=\u0026quot;1451\u0026quot;\u0026gt;• Become well-versed in relevant disease states, related literature, and KK rare disease-focused products.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;1453\u0026quot; data-end=\u0026quot;1617\u0026quot;\u0026gt;• Participate in and contribute to annual strategic medical planning and serve as a core member of the Rare Disease Medical Affairs Strategy Team for North America.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;1619\u0026quot; data-end=\u0026quot;1708\u0026quot;\u0026gt;• Lead the development and execution of KOL engagement and territory planning strategies.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;1710\u0026quot; data-end=\u0026quot;1962\u0026quot;\u0026gt;• Contribute to the development of the MSL skills training plan and lead the development of the rare disease scientific training plan. Coordinate with relevant internal partners to identify educational gaps and organize team and/or individual training.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;1964\u0026quot; data-end=\u0026quot;2103\u0026quot;\u0026gt;• Hire, train, develop, inspire, and mentor field-based MSL team members, including conducting quarterly field rides with each team member.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;2105\u0026quot; data-end=\u0026quot;2191\u0026quot;\u0026gt;• Work regularly in the field (territories and conferences) with each MSL on the team.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;2193\u0026quot; data-end=\u0026quot;2235\u0026quot;\u0026gt;• Create and execute a strategic MSL plan.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;2237\u0026quot; data-end=\u0026quot;2303\u0026quot;\u0026gt;• Develop team goals and provide ongoing coaching to team members.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;2305\u0026quot; data-end=\u0026quot;2350\u0026quot;\u0026gt;• Manage MSL team performance and compliance.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;2352\u0026quot; data-end=\u0026quot;2431\u0026quot;\u0026gt;• Compile, organize, collate, and synthesize insights gathered by the MSL team.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;2433\u0026quot; data-end=\u0026quot;2547\u0026quot;\u0026gt;• Create and execute a strategic disease area MSL plan, including KPI definition, metrics tracking, and reporting.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;2549\u0026quot; data-end=\u0026quot;2614\u0026quot;\u0026gt;• Model best practices for insight gathering across the MSL team.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;2616\u0026quot; data-end=\u0026quot;2740\u0026quot;\u0026gt;• Assist MSL team members in guiding healthcare professionals through the submission of IIS proposals via the online portal.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;2742\u0026quot; data-end=\u0026quot;2865\u0026quot;\u0026gt;• Support MSLs in educating healthcare professionals and managed market decision-makers on Kyowa Kirin’s product portfolio.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;2867\u0026quot; data-end=\u0026quot;3047\u0026quot;\u0026gt;• Ensure the appropriate dissemination of transparent, fair-balanced scientific and clinical information, knowledge, and services in a timely, ethical, and customer-focused manner.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;3049\u0026quot; data-end=\u0026quot;3197\u0026quot;\u0026gt;• Facilitate speaker development and provide support for speaker training and annual speaker audits in collaboration with cross-functional partners.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;3199\u0026quot; data-end=\u0026quot;3299\u0026quot;\u0026gt;• Attend and provide scientific support at select national, regional, and local medical conferences.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;3301\u0026quot; data-end=\u0026quot;3395\u0026quot;\u0026gt;• Actively participate in advisory boards and clinical investigator meetings when appropriate.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;3397\u0026quot; data-end=\u0026quot;3635\u0026quot;\u0026gt;• Recognize the value of MSL insights and ensure the delivery of high-quality insight reports to Medical Affairs colleagues by synthesizing information gathered through field interactions with healthcare professionals and thought leaders.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;3637\u0026quot; data-end=\u0026quot;3836\u0026quot;\u0026gt;• Identify team members’ strengths, development opportunities, and interests, and develop Individual Development Plans (IDPs) that leverage strengths, enhance capabilities, and support career growth.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;3838\u0026quot; data-end=\u0026quot;3975\u0026quot;\u0026gt;• Assign projects aligned with Individual Development Plans and team objectives to further develop team members’ skills and capabilities.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;3977\u0026quot; data-end=\u0026quot;4049\u0026quot;\u0026gt;• Adhere to all company regulatory, compliance, and policy requirements.\u0026lt;/p\u0026gt;\n\u0026lt;hr data-start=\u0026quot;4051\u0026quot; data-end=\u0026quot;4054\u0026quot;\u0026gt;\n\u0026lt;h3 data-section-id=\u0026quot;g9ewcs\u0026quot; data-start=\u0026quot;4056\u0026quot; data-end=\u0026quot;4069\u0026quot;\u0026gt;Education\u0026lt;/h3\u0026gt;\n\u0026lt;p data-start=\u0026quot;4071\u0026quot; data-end=\u0026quot;4166\u0026quot;\u0026gt;Advanced degree in medical science (MD, PharmD, or PhD) or healthcare professional credentials.\u0026lt;/p\u0026gt;\n\u0026lt;h3 data-section-id=\u0026quot;1n71tnc\u0026quot; data-start=\u0026quot;4168\u0026quot; data-end=\u0026quot;4182\u0026quot;\u0026gt;Experience\u0026lt;/h3\u0026gt;\n\u0026lt;p data-start=\u0026quot;4184\u0026quot; data-end=\u0026quot;4350\u0026quot;\u0026gt;• Minimum of five (5) years of field-based Medical Affairs experience, including at least four (4) years of field medical or Medical Science Liaison (MSL) experience.\u0026lt;/p\u0026gt;\n\u0026lt;p data-start=\u0026quot;4352\u0026quot; data-end=\u0026quot;4478\u0026quot;\u0026gt;• Prior people leadership or management experience within Medical Affairs, MSL, or a related discipline is strongly preferred.\u0026lt;/p\u0026gt;\n\u0026lt;h3 data-section-id=\u0026quot;2xrgif\u0026quot; data-start=\u0026quot;4480\u0026quot; data-end=\u0026quot;4500\u0026quot;\u0026gt;Technical Skills\u0026lt;/h3\u0026gt;\n\u0026lt;p data-start=\u0026quot;4502\u0026quot; data-end=\u0026quot;5135\u0026quot;\u0026gt;Outstanding leadership abilities including a demonstrated capacity to lead, inspire and build collaborative relationships, and manage/resolve conflicts effectively. Results-driven with a collaborative, team-oriented mindset. Demonstrated success in working well cross-functionally. Deep understanding of drug development, legal and regulatory compliance guidelines. Excellent communication skills (written, verbal, listening, and presentation). Strong experience using Microsoft Office Suite including Word, Excel, and PowerPoint. Commitment to the highest ethical, legal, regulatory, and scientific standards in all aspects of work.\u0026lt;/p\u0026gt;\n\u0026lt;h3 data-section-id=\u0026quot;onbf79\u0026quot; data-start=\u0026quot;5137\u0026quot; data-end=\u0026quot;5161\u0026quot;\u0026gt;Non-Technical Skills\u0026lt;/h3\u0026gt;\n\u0026lt;p data-start=\u0026quot;5163\u0026quot; data-end=\u0026quot;5553\u0026quot;\u0026gt;Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Detail-oriented with excellent follow-through. Ability to flex and deal with ambiguity in a dynamic, fast-paced, high-growth environment. Passion for personal learning and development. Cultural sensitivity and ability to develop consensus within a multinational organization.\u0026lt;/p\u0026gt;\n\u0026lt;h3 data-section-id=\u0026quot;ewa2rj\u0026quot; data-start=\u0026quot;5555\u0026quot; data-end=\u0026quot;5580\u0026quot;\u0026gt;Physical Requirements\u0026lt;/h3\u0026gt;\n\u0026lt;p data-start=\u0026quot;5582\u0026quot; data-end=\u0026quot;5714\u0026quot;\u0026gt;Physical Demands: Normal office environment with prolonged sitting and extensive computer work. Ability to drive or fly to meetings.\u0026lt;/p\u0026gt;\n\u0026lt;h3 data-section-id=\u0026quot;b6ss1z\u0026quot; data-start=\u0026quot;5716\u0026quot; data-end=\u0026quot;5738\u0026quot;\u0026gt;Working Conditions\u0026lt;/h3\u0026gt;\n\u0026lt;p data-start=\u0026quot;5740\u0026quot; data-end=\u0026quot;5793\u0026quot; data-is-last-node=\u0026quot;\u0026quot; data-is-only-node=\u0026quot;\u0026quot;\u0026gt;Requires up to 70% domestic and international travel.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be\u0026amp;nbsp;\u0026lt;strong\u0026gt;$$220,000 to $280,000.\u0026lt;/strong\u0026gt;\u0026amp;nbsp;\u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company match\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Services\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at\u0026amp;nbsp;\u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt;\u0026amp;nbsp;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-PE1\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-FIELD\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;","departments":[{"id":4042022003,"name":"Rare Disease Medical Affairs","child_ids":[],"parent_id":4017391003}],"offices":[{"id":4061217003,"name":"Field","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7684366003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5742550003,"location":{"name":"Remote"},"metadata":null,"id":7684366003,"updated_at":"2026-05-27T15:00:36-04:00","requisition_id":"1377","title":"Executive Director, North America Head of Medical Field Teams","company_name":"Kyowa Kirin North America","first_published":"2026-03-31T13:21:04-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary of Job:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The NA Head of Medical Field Teams is a senior Medical Affairs leadership role responsible for the strategic leadership, oversight, and performance of the North America Field Medical organization. This role plays a key part in building and evolving the North America Field Medical function, including shaping the operating model, core processes, governance, and standards of excellence for MSL and HEOR field activities as the organization continues to grow.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The role oversees several MSL teams across different therapeutic areas, as well as a Medical Value Outcome Liaison (MVOL)\u0026amp;nbsp; team, ensuring high quality, compliant scientific and health economic exchange aligned with regional and global Medical Affairs strategy.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The NA Head of Medical Field Teams is accountable for defining the field medical and HEOR engagement vision, operating model, and standards of excellence across therapeutic areas, while enabling strong execution, insight generation, and cross-functional collaboration. The role partners closely with Therapeutic Area leadership, HEOR leadership, Medical Affairs Operations \u0026amp;amp; Excellence, Scientific Communications, and Global Medical Affairs to ensure integrated scientific and value-based engagement across the product lifecycle and is responsible for effectively communicating the value of Field Medical and Medical Value and Outcomes Liaisons (MVOL) team to senior leadership and other stakeholders through advanced analytics and reporting of outcomes and impact.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;u\u0026gt;Field Medical \u0026amp;amp; HEOR Strategy and Leadership\u0026lt;/u\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Define and own the North America Field Medical and Medical Value Outcome Liaison (MVOL) Field strategy across multiple therapeutic areas, aligned with regional and global Medical Affairs objectives.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide strategic leadership and direction to several TA MSL teams and Medical Value Outcome Liaison (MVOL) team, ensuring clear role differentiation while maintaining consistency in standards, expectations, and ways of working.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Translate medical and HEOR strategy into field engagement models, priorities, and annual plans across therapeutic areas and assets.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as the senior field medical and Medical Value Outcome Liaison (MVOL) voice within North America Medical Affairs leadership forums.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;u\u0026gt;People Leadership \u0026amp;amp; Talent Development\u0026lt;/u\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Directly lead and develop MSL and Medical Value Outcome Liaison (MVOL) people managers across therapeutic areas.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Build a high-performing, patient-centric Field Medical and Medical Value Outcome Liaison (MVOL) organization through coaching, performance management, and professional development.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee hiring, onboarding, training, and succession planning for MSL and Medical Value Outcome Liaison (MVOL) teams.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Foster a culture of scientific excellence, value-based thinking, compliance, collaboration, and continuous improvement.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;u\u0026gt;Scientific, HEOR \u0026amp;amp; External Engagement Excellence\u0026lt;/u\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Ensure high quality, non-promotional scientific and health economic exchange with healthcare professionals, payers, decision makers, and other external stakeholders.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee field medical and HEOR engagement strategies, ensuring interactions are compliant, scientifically rigorous, and tailored to stakeholder needs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Guide MSL and Medical Value Outcome Liaison (MVOL) involvement in advisory boards, payer engagements, investigator meetings, congresses, and insight generation activities.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;u\u0026gt;Insights Generation \u0026amp;amp; Strategic Impact\u0026lt;/u\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provides strategic leadership and direction to the data innovation strategy utilizing systems and analytics to establish and oversee robust processes for collection, synthesis, and communication of scientific, clinical, and HEOR field-generated insights.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure insights inform medical strategy, evidence generation, value messaging, scientific communications, and development planning.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with Therapeutic Area Heads, HEOR leadership, and Asset Leads to translate insights into strategic actions.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;u\u0026gt;Cross-Functional \u0026amp;amp; Matrix Collaboration\u0026lt;/u\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Partner closely with Therapeutic Area Heads, Regional Asset Leads, HEOR leadership, and Scientific Communications to ensure alignment between field execution and medical and value strategies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with Medical Affairs Operations \u0026amp;amp; Excellence on field medical and HEOR planning, resourcing, KPIs, and operational excellence.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Work in close partnership with Clinical Development, Regulatory, Legal, and Compliance to support integrated and compliant execution.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as a key liaison between North America Field Medical/ Medical Value Outcome Liaison (MVOL) teams and Global Medical Affairs and Global HEOR leadership.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;u\u0026gt;Governance, Compliance \u0026amp;amp; Quality\u0026lt;/u\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Ensure all MSL and Medical Value Outcome Liaison (MVOL) activities comply with internal SOPs, Medical Affairs governance, and external regulatory and industry standards.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee training and adherence to compliance requirements related to scientific exchange, health economic discussions, and non-promotional engagement.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify and escalate scientific, compliance, or reputational risks related to field medical or Medical Value Outcome Liaison (MVOL) activities.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;u\u0026gt;Key Interfaces\u0026lt;/u\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Head of North America Medical Affairs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Regional Therapeutic Area Heads\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Regional Asset Medical Leads\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Medical Affairs Operations \u0026amp;amp; Excellence\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Scientific Communications Leadership\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Global HEOR, and Global Medical Affairs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Clinical Development, Regulatory, Legal, and Compliance partners\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;u\u0026gt;Decision‑Making Authority\u0026lt;/u\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Accountable for North America Field Medical and HEOR Field strategy, structure, and performance across therapeutic areas.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Authority to define field engagement models, priorities, and resource allocation within approved plans.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Input into Medical Affairs resourcing, organizational design, and capability development decisions.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Escalation authority for field‑related scientific, HEOR, compliance, or operational risks.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Subordinates\u0026lt;/strong\u0026gt;: MSL Directors\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Job Requirements:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Bachelor’s degree in life science, nursing or closely related discipline.\u0026amp;nbsp; A doctorate level degree (e.g. MD, PharmD, PhD) in life sciences with relevant experience is highly preferred.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Experience\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Minimum 15 years of progressive experience in Medical Affairs, including significant leadership of Field Medical (MSL) organizations within the pharmaceutical or biotechnology industry\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated success leading large, multi-therapeutic area Field Medical teams, including direct oversight of MSL leaders and HEOR/MVOL functions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven track record of defining and executing Field Medical and HEOR strategies aligned with regional and global Medical Affairs objectives\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Extensive experience engaging with key external stakeholders, including healthcare professionals, payers, and decision-makers, through compliant scientific and health economic exchange\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong background in building and scaling high-performing teams, including organizational design, talent development, and succession planning\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience operating within complex, matrixed organizations with demonstrated ability to influence cross-functional stakeholders and drive strategic alignment across Medical Affairs, Clinical, Regulatory, and Commercial partners\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Proven expertise in leading Field Medical organizations, including MSL and HEOR/MVOL teams, across multiple therapeutic areas\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong command of Medical Affairs strategy, including field engagement models, insight generation, and evidence-based scientific exchange\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced knowledge of health economics, outcomes research (HEOR), and value-based healthcare principles\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to translate medical and HEOR strategies into operational plans, KPIs, and measurable field execution frameworks\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with data analytics, insight platforms, and systems to capture, synthesize, and operationalize field-generated insights Deep understanding of compliance frameworks, including FDA regulations, industry guidelines, and non-promotional engagement standards\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exceptional cross-functional leadership and matrix collaboration skills across Clinical Development, Regulatory, Legal, and Commercial interfaces\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficient in MS Office Suite and Veeva.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Non-Technical Skills\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Strong management skills with demonstrated ability to plan for resourcing needs, set goals and objectives, establish and recalibrate priorities, provide feedback and appraise work. Ability to regularly assess individual’s skills, talents and career interests to ensure talent development. Demonstrated ability to organize, prioritize, meet deadlines, make decisions, and change course of action quickly. Strong interpersonal and communication skills. A strong work ethic is required. Detail-oriented and excellent follow-through. Has the ability to flex and deal with ambiguity in a dynamic, fast-paced, high-growth environment. Has a passion for personal learning and development to be able to grow with the company. Cultural sensitivity and ability to develop consensus within a multinational organization.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Physical Demands; Normal office environment with prolonged sitting and extensive computer work. Ability to drive or fly to meetings.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Working Conditions: Requires up to 50% domestic and international travel, including some weekend commitments.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be \u0026lt;strong\u0026gt;$256,800 to $332,300.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company match\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Services\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-JC1\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-Remote\u0026lt;/p\u0026gt;","departments":[{"id":4017391003,"name":"Medical Affairs","child_ids":[4064391003,4042021003,4042022003],"parent_id":null}],"offices":[{"id":4010013003,"name":"Princeton","location":"Princeton, New Jersey, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/6069021003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":null,"location":{"name":"Princeton, NJ"},"metadata":null,"id":6069021003,"updated_at":"2026-03-20T08:22:19-04:00","requisition_id":null,"title":"Join the Kyowa Kirin Talent Community!","company_name":"Kyowa Kirin North America","first_published":"2024-07-25T15:33:01-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Thank you for your interest in a career with Kyowa Kirin. Below you will find an application to join our Talent Community. After applying, you will be added to our talent pipeline for future opportunities.\u0026amp;nbsp;\u0026lt;/p\u0026gt;","departments":[],"offices":[]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7749842003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5771254003,"location":{"name":"Sanford, NC"},"metadata":null,"id":7749842003,"updated_at":"2026-06-01T09:28:22-04:00","requisition_id":"1404","title":"Lead Validation Engineer","company_name":"Kyowa Kirin North America","first_published":"2026-06-01T09:28:22-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Summary of Job:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Lead Validation Engineer will lead the day-to-day activities for CQV of process equipment, facilities, utilities, and automation systems at the NC Manufacturing Facility. Following project implementation, the Lead Validation Engineer will be responsible for EQV/CSV activities at the site as it transitions into further tech transfer activities and routine operations. The Lead Validation Engineer will also support process validation, cleaning validation, or shipping validation activities.\u0026lt;br\u0026gt;As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. The Lead Validation Engineer will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, as the Lead Validation Engineer, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Essential Functions:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Technical Skills, Knowledge, and Experience Commissioning \u0026amp;amp; Qualification (CQ)\u0026lt;br\u0026gt;• Develop and implement commissioning and qualification strategies for:\u0026lt;br\u0026gt;o Manufacturing equipment\u0026lt;br\u0026gt;o Process equipment\u0026lt;br\u0026gt;o Facilities and cleanrooms\u0026lt;br\u0026gt;o Critical utilities (HVAC, WFI, compressed gases, etc.)\u0026lt;br\u0026gt;• Oversee day-to-day activities for execution of DQ, IQ, OQ, and PQ\u0026lt;br\u0026gt;• Oversee generation of equipment and system lifecycle document generation\u0026lt;br\u0026gt;• Ensure traceability to user requirements and regulatory expectations\u0026lt;br\u0026gt;• Support startup, tech transfer, and commercial readiness activities\u0026lt;br\u0026gt;Computer System Validation (CSV)\u0026lt;br\u0026gt;• Lead day-to-day activities for validation of computerized systems including:\u0026lt;br\u0026gt;o Manufacturing Execution Systems (MES)\u0026lt;br\u0026gt;o Quality systems (EDMS)\u0026lt;br\u0026gt;o Automation and control systems (PLC, SCADA, DCS)\u0026lt;br\u0026gt;• Ensure compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11\u0026lt;br\u0026gt;• Approve validation plans, risk assessments, protocols, and final reports\u0026lt;br\u0026gt;• Perform data integrity assessments and periodic reviews Process, Cleaning, and Shipping Validation\u0026lt;br\u0026gt;• Develop and implement site process, cleaning and shipping validation programs\u0026lt;br\u0026gt;• Drive completion of process validation, cleaning validation and shipping validation activities to support commercial operations Compliance \u0026amp;amp; Quality\u0026lt;br\u0026gt;• Ensure validation lifecycle documentation meets regulatory and internal quality standards\u0026lt;br\u0026gt;• Support regulatory inspections and audits (FDA, EMA, MHRA, etc.)\u0026lt;br\u0026gt;• Address audit observations, deviations, CAPAs, and change controls related to validation\u0026lt;br\u0026gt;• Drive use of risk-based validation approaches and continuous improvement initiatives Project \u0026amp;amp; Stakeholder Management\u0026lt;br\u0026gt;• Partner with Engineering, IT, Quality, Manufacturing, and Automation teams\u0026lt;br\u0026gt;• Support capital projects, expansions, and new product introductions\u0026lt;br\u0026gt;• Support tech transfer and process validation activities\u0026lt;br\u0026gt;• Provide clear communication and reporting to team members and area functional leads\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education and Experience\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;• The following combination of education and professional experience is required for this role:\u0026lt;br\u0026gt;o Bachelor’s degree in a technical field required. Formal GMP and Safety training is essential.\u0026lt;br\u0026gt;o At least 7 years of experience in CQV for BioPharma Manufacturing or Capital Projects, with experience validating process equipment, facilities, utilities, and automation systems. Experience with leading validation for projects is essential. Experience with Process Validation, Shipping Validation, Cleaning Validation or Tech Transfer is a plus.\u0026lt;br\u0026gt;o Experience working with and leading a small group of contractors or consultants\u0026lt;br\u0026gt;\u0026lt;br\u0026gt;\u0026lt;strong\u0026gt;Technical Skills:\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;Proficient in MS Office Suite\u0026lt;br\u0026gt;Knowledgeable in cGMPs, GAMP, Safety Practices, Regulatory Compliance, Protocol Development and Execution, Risk Assessment, Criticality Assessment and System Turnover/Training.•\u0026lt;br\u0026gt;Experience using a digital validation lifecycle management system\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;br\u0026gt;\u0026lt;strong\u0026gt;Non-Technical Skills:\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others\u0026#39; perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Physical Demands\u0026lt;/strong\u0026gt;: Initially, position requires working on a construction site and will ultimately transition to the biotech manufacturing site in Sanford, NC.\u0026lt;br\u0026gt;Work is 100% on-site. This is not a hybrid or remote role.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Working Conditions: May require up to 10% domestic and limited international travel\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be $145,100 to $177,300. \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company matching\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long-Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Service\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-JC1\u0026lt;/p\u0026gt;","departments":[{"id":4063732003,"name":"Engineering","child_ids":[],"parent_id":4051418003}],"offices":[{"id":4053087003,"name":"Sanford","location":"Sanford, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7728401003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5762263003,"location":{"name":"Princeton, New Jersey"},"metadata":null,"id":7728401003,"updated_at":"2026-05-08T11:36:11-04:00","requisition_id":"1397","title":"Manager, ICT Delivery","company_name":"Kyowa Kirin North America","first_published":"2026-05-08T11:18:54-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Manager, ICT Delivery plays a critical role in delivery of complex technology projects and IT services. They combine strategic planning with tactical execution to align team output with broader organizational goals, managing everything from initial scoping to final deployment and post-launch support. \u0026amp;nbsp;They ensure that digital initiatives are executed efficiently, securely and in alignment with GxP standards. They exhibit strong delivery leadership with a deep appreciation for the complexities of the pharmaceutical environment.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Participate in project planning, execution, risk management, and quality assurance across multiple concurrent initiatives.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure solutions meet regulatory and data privacy requirements, including GxP, 21 CFR Part 11, HIPPA, GDPR and data integrity standards.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Apply and follow appropriate delivery methodologies (Agile, Waterfall, hybrid) based on project needs and compliance considerations.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate with business, technical teams and vendors to ensure accurate translation of business requirements into technical solutions.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Assume accountability throughout all phases of system development lifecycle from ideation and planning through production support and troubleshooting.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Additional activities may include, but are not limited to:\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;IT Project Oversight - Review project timelines, milestones, risks and budget to ensure delivery stays on track.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Stakeholder Communication \u0026amp;amp; Alignment - Manage expectations, clarify priorities and drive compromise between business needs and technical constraints.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;SDLC Compliance – Ensure all system changes follow appropriate lifecycle processes; review documentation for accuracy, completeness, and audit readiness.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Issue Resolution \u0026amp;amp; Operational Support – Assist in the triage of issues / incidents that impact production systems or project timelines.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Education\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;Bachelor’s degree or equivalent experience in computer science, information systems, engineering or related fields required\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Experience\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;At least 5 years’ experience delivering IT projects within a regulated industry, ideally pharmaceuticals or life sciences; Familiarity with multiple functional domains (e.g. Quality, Regulatory, Medical, Commercial and/or Clinical); Knowledge of GxP compliance, validation practices and regulated system requirements; \u0026amp;nbsp;Experience with large-scale, global implementations; Experience with enterprise technologies such as Veeva Vault, Salesforce.com, Microsoft Dynamics\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Technical Skills\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;Proficient in MS Office Suite.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Working Conditions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Requires up to 10% domestic and international travel\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be \u0026lt;strong\u0026gt;$121,000 to $156,800.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company match\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Services\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-TT1 #Hybrid #Princeton\u0026lt;/p\u0026gt;","departments":[{"id":4017385003,"name":"Information Technology","child_ids":[],"parent_id":null}],"offices":[{"id":4010013003,"name":"Princeton","location":"Princeton, New Jersey, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7579607003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5697188003,"location":{"name":"Sanford, NC"},"metadata":null,"id":7579607003,"updated_at":"2026-06-01T09:04:26-04:00","requisition_id":"1291","title":"Manufacturing Operator III","company_name":"Kyowa Kirin North America","first_published":"2026-01-07T09:36:20-05:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As a Manufacturing Operator III supporting a greenfield biopharmaceutical site focused on rare disease therapies, you will play a key role in launching and executing core manufacturing operations:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Serve as a role model for safety and GMP compliance.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Execute complex upstream and downstream processes in a regulated environment.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Participates in equipment commissioning, process validation, and automation implementation.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate cross-functionally with Engineering, Automation, and Quality teams.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support troubleshooting and continuous improvement initiatives.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proactively identify, escalate, and respond to deviations, equipment issues, or process anomalies to ensure product quality and operational continuity.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Train and mentor other manufacturing associates to build team capability.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Contribute to the development of a high-performing, patient-centered manufacturing platform from the ground up.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As an individual contributor, you will take a compassionate and people-focused approach to your work, proactively collaborate with others to create a supportive and inclusive environment, and always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. \u0026amp;nbsp;You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role reports to the Manager, Manufacturing\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Executes manufacturing operations in accordance with standard work and work instructions for monoclonal antibody (mAb) production, including weigh and dispense, buffer and media preparation, bioreactors, filtration systems, inoculum preparation, chromatography skids, and UF/DF skids via PCS and MES systems.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensures all processes are performed in accordance with Safety and Compliance policies, current Good Manufacturing Practices (cGMP), and Data Integrity principles (ALCOA+), as well as all other applicable regulatory requirements.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Follows operational procedures and master batch records, adhering to both written and verbal instructions from supervisors. Maintains accurate and complete documentation, including batch records, logbooks, and other required records.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Takes immediate action when deviations, equipment malfunctions, or unexpected results occur, including stopping the process if necessary to prevent impact to product quality or safety.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Escalates all actual or perceived non-compliance events, safety concerns, or process deviations promptly and appropriately, ensuring timely resolution and documentation.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborates with Process Engineering, Automation, CQV, Quality, Operational Excellence (OPEX), and Warehouse teams to ensure compliant and efficient operations during commissioning and routine manufacturing.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Contributes to the development of standard operating procedures (SOPs) and facilitates equipment validation and qualification in collaboration with engineering teams.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Identifies and implements process improvements to optimize manufacturing operations. Leads or contributes to initiatives that streamline workflows, eliminate waste, and enhance productivity.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Demonstrates working knowledge of enterprise systems supporting manufacturing operations, including but not limited to ERP, LIMS, MES, PCS, QMS, and BMS.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Leads on-the-floor troubleshooting and resolution of equipment, automation, and process-related issues. Supports CAPA documentation and tracking.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Maintains cleanliness and organization of the manufacturing area by performing routine cleaning and preventive maintenance in compliance with GMP and safety standards.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Applies 5S, standard work, and Kanban principles to manage the shop floor. Coordinates with Warehouse and Maintenance teams to ensure availability of materials, supplies, and equipment for uninterrupted production.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Trains and mentors new team members in manufacturing processes, equipment operation, safety procedures, and company standards to ensure team competency and adherence to best practices.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Assists in the technical transfer of new products and processes into the manufacturing area.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role is an Individual contributor\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Education and Experience\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Bachelor’s degree in a technical or scientific discipline (e.g., Chemical Engineering, Chemistry, Biology, or related field) and at least 2 years of relevant experience in biopharmaceutical manufacturing.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Associate degree in a technical field and at least 4 years of relevant experience in biopharmaceutical manufacturing.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;High school diploma or equivalent and at least 6 years of relevant experience in biopharmaceutical manufacturing.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience with start-up and operation of biopharmaceutical manufacturing processes is strongly preferred.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Hands-on experience with key unit operations including solution preparation, upstream and/or downstream processing, inoculation, and weigh \u0026amp;amp; dispense activities.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Familiarity with Agile and Lean manufacturing principles, including the use of Standard Work.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience in technical writing; ability to author and edit SOPs is a plus.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proficient in Microsoft Office applications.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Strong problem-solving and critical thinking skills.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Working knowledge of MES, BMS, and PCS systems is a plus.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Maintains clean and compliant manufacturing environments in accordance with GMP and safety standards.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Skilled in reading and interpreting technical documents, troubleshooting issues, and operating production equipment.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proficient in English, with the ability to perform basic math and statistical calculations.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Non-Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Results-oriented and able to navigate ambiguity.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Respond promptly, take accountability, and manage tasks efficiently.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Communicate with care by actively listening and considering others\u0026#39; perspectives, fostering productive, engaging interactions, and managing relationships with kindness.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Contribute positively by recognizing achievements and encouraging a healthy work-life balance.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;During construction and commissioning, this position will follow a Monday–Friday day shift schedule. Once the facility is operational, the role will transition to a 2-2-3 day shift (7:00 AM – 7:00 PM). Shift flexibility may be required during production runs.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;The position will begin on a construction site and transition to a fully operational biopharmaceutical manufacturing facility in Sanford, NC.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Must be able to lift up to 35 lbs and move heavy objects such as material containers, bagged product, and pallets. Must also be able to stand for 3 or more hours while operating equipment.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Must be able to work in a regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Requires up to 10% domestic and international travel.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;During the start-up phase, this role may require up to three months of training at our Japan manufacturing site, to be completed within the next two years.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be\u0026amp;nbsp;\u0026lt;strong\u0026gt;$40 pr/hr to $42 pr/hr.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company matching\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Discretionary Profit Sharing\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long-Term Incentives\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Service\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-SH1\u0026lt;/p\u0026gt;","departments":[{"id":4051418003,"name":"Manufacturing","child_ids":[4063734003,4063732003,4063733003],"parent_id":null}],"offices":[{"id":4053087003,"name":"Sanford","location":"Sanford, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7679054003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5739661003,"location":{"name":"Charlotte, NC"},"metadata":null,"id":7679054003,"updated_at":"2026-03-25T14:11:21-04:00","requisition_id":"1375","title":" Oncology Account Manager - Charlotte, NC","company_name":"Kyowa Kirin North America","first_published":"2026-03-25T14:11:21-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This territory covers parts of Charlotte, NC; Columbia, SC; and extends south to Charleston, SC. Candidates must be willing to travel throughout the territory\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Oncology Account Manager is a critical role in establishing KKNA as a leader in Oncology and Rare Diseases by demonstrating our commitment to supporting the efforts of Oncology/Rare Disease healthcare providers in improving patient health outcomes and becoming a trusted resource in demonstrating value along the patient journey. .\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The individual in the role will drive an effective hospital system and account planning, management, and selling process for hospital systems/accounts. He/she will identify the key stakeholders within the assigned hospital systems/accounts and build strong relationships with those individuals along the patient journey.\u0026amp;nbsp; This includes understanding and educating referral networks to identify appropriate patients, converting to Poteligeo where appropriate, and ensuring maintenance on Poteligeo by supporting appropriate multidisciplinary support of the patients via their care network. The Oncology Account Manager also serves as the lead point of contact for account management activities within the assigned hospital networks, academic Institutions, and surrounding practices, working closely with Market Access, Sales, Marketing, and Medical Affairs Teams.\u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Effective hospital system and account planning, management, and selling process\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Drive effective account planning \u0026amp;amp; management process for target hospital systems, the patient journey for that system, identifying key influencers within the account, and building relationships to drive sales\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and maintain a deep understanding of the oncology and dermatology centers in assigned regions, identifying and mapping key stakeholders and patient flows.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Understands and applies knowledge of the health care industry, trends, market conditions, and market access environment within the Oncology and Dermatology market space, including but not limited to pharmacy-economics, and payer/reimbursement landscape.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support market access needs when necessary\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and analyze product performance within accounts and take and/or evolve actions as appropriate.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Understanding and educating referral networks to Identify Appropriate Patients \u0026amp;amp; support maintenance\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Map patient flow/influence between institutions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Educate referral networks and co-management networks on disease best practice\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Analyze these factors (patient flow/between institutions and community practices) in the development of business plans and in the daily execution of sales calls\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify and track potential patients for follow-up with HCP\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure maintenance on Poteligeo by supporting appropriate multidisciplinary HCP support of the patients via their care network.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Converting to Poteligeo where appropriate\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Demonstrate a strong understanding of current or pending clinical pathways within an institution\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate cross-functionally with internal/external customers to develop and implement actionable business plans that drive any formularies and protocols/pathways additions that are required to drive sales volume within an account.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Conduct formal and informal presentations and convey complex scientific information fluently in a professional, compliant, ethical, and effective manner.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure access to KKNA’s products for all accounts by working with KOLs, providers, pharmacy, and P\u0026amp;amp;T where appropriate.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated highly effective account management skills and exemplary selling competencies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintains knowledge of Oncology and Rare Disease standards of care and emerging clinical trends, and is able to articulate approved, on-label product information related to these topics.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Compliant\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Refers requests for off-label information to KKNA’s medical department through the MIR process\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strictly adhere to relevant regulatory and compliance guidelines and company policies.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Requirements\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree required.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Experience\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A minimum of 5 years of pharmaceutical sales experience with a minimum of 3 years of pharmaceutical account management experience.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A minimum of 3 years’ experience within institutional, oncology, or rare disease sales.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven track record of sales success.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Must have a high degree of understanding of the Buy \u0026amp;amp; Bill \u0026amp;amp; Market Access marketplace.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Must have a strong track record of therapeutic area/product knowledge.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Proficient in MS Office Suite and Veeva is a must.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent organizational/communication skills, initiative, and ambition to succeed are all essential.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Valid US Driver’s License\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Non-Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Highly motivated and with great attention to detail. Strong endurance to work under tight timelines and complex/changing situations.\u0026amp;nbsp; Excellent written and oral communication skills including the ability to present via PowerPoint in front of large groups. Excellent problem-solving skills. Broad level of interpersonal skills and flexibility.\u0026amp;nbsp;\u0026amp;nbsp; Cultural sensitivity and ability to develop consensus within a multinational organization.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Physical Demands:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Normal office environment with prolonged sitting and extensive computer work. Extensive driving and potential air travel with overnights are expected in some territories. The ability to safely and successfully operate a motor vehicle is required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;This position will be field based and will require approx. 50% overnight travel depending on territory.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at\u0026amp;nbsp;\u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt;\u0026amp;nbsp;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Annualized base salary ranges from $150,000 – $175,000 plus sales incentive; actual salaries will vary and may be above or below this range commensurate with various factors including but not limited to experience, education, training, and merit.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This position is eligible for a company car through the Company’s FLEET program.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin provides a comprehensive compensation and benefits package which includes:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Medical, Dental \u0026amp;amp; Vision Insurance, Basic and Voluntary Life and AD\u0026amp;amp;D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, and Health Savings Account, Business Travel Insurance, Employee Assistance Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Retirement Savings 401k with company match and annual discretionary profit sharing\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work-Life Programs Including Gympass, Nutrition Counseling, , Volunteer Time Off, Flexible Work Arrangements, Parental Leave, Adoption Assistance, and TouchCare Insurance \u0026amp;amp; Billing Support\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous Paid Time Off, Sick Time, \u0026amp;amp; Paid Holidays\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Perks and Discounts with Tickets at Work and LifeMart\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Reward \u0026amp;amp; Recognition Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Career Development and Training\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-PE1\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-Field\u0026amp;nbsp;\u0026lt;/p\u0026gt;","departments":[{"id":4040125003,"name":"Oncology Sales","child_ids":[],"parent_id":4017399003}],"offices":[{"id":4061217003,"name":"Field","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7747049003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5770029003,"location":{"name":"Dallas TX"},"metadata":null,"id":7747049003,"updated_at":"2026-05-27T12:10:20-04:00","requisition_id":"1402","title":" Oncology Account Manager - Dallas TX","company_name":"Kyowa Kirin North America","first_published":"2026-05-26T07:52:19-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to make people smile by delivering breakthroughs where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, Massachusetts, and Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Key cities and coverage areas include:Dallas–Fort Worth–Arlington Metroplex | Abilene, TX | Lubbock, TX | Midland–Odessa, TX | Amarillo, TX | El Paso, TX | Las Cruces, NM\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Oncology Account Manager is a critical role in establishing KKNA as a leader in Oncology and Rare Diseases by demonstrating our commitment to supporting the efforts of Oncology/Rare Disease healthcare providers in improving patient health outcomes and becoming a trusted resource in demonstrating value along the patient journey. .\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The individual in the role will drive an effective hospital system and account planning, management, and selling process for hospital systems/accounts. He/she will identify the key stakeholders within the assigned hospital systems/accounts and build strong relationships with those individuals along the patient journey.\u0026amp;nbsp; This includes understanding and educating referral networks to identify appropriate patients, converting to Poteligeo where appropriate, and ensuring maintenance on Poteligeo by supporting appropriate multidisciplinary support of the patients via their care network. The Oncology Account Manager also serves as the lead point of contact for account management activities within the assigned hospital networks, academic Institutions, and surrounding practices, working closely with Market Access, Sales, Marketing, and Medical Affairs Teams.\u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Effective hospital system and account planning, management, and selling process\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Drive effective account planning \u0026amp;amp; management process for target hospital systems, the patient journey for that system, identifying key influencers within the account, and building relationships to drive sales\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and maintain a deep understanding of the oncology and dermatology centers in assigned regions, identifying and mapping key stakeholders and patient flows.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Understands and applies knowledge of the health care industry, trends, market conditions, and market access environment within the Oncology and Dermatology market space, including but not limited to pharmacy-economics, and payer/reimbursement landscape.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support market access needs when necessary\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and analyze product performance within accounts and take and/or evolve actions as appropriate.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Understanding and educating referral networks to Identify Appropriate Patients \u0026amp;amp; support maintenance\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Map patient flow/influence between institutions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Educate referral networks and co-management networks on disease best practice\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Analyze these factors (patient flow/between institutions and community practices) in the development of business plans and in the daily execution of sales calls\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify and track potential patients for follow-up with HCP\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure maintenance on Poteligeo by supporting appropriate multidisciplinary HCP support of the patients via their care network.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Converting to Poteligeo where appropriate\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Demonstrate a strong understanding of current or pending clinical pathways within an institution\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate cross-functionally with internal/external customers to develop and implement actionable business plans that drive any formularies and protocols/pathways additions that are required to drive sales volume within an account.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Conduct formal and informal presentations and convey complex scientific information fluently in a professional, compliant, ethical, and effective manner.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure access to KKNA’s products for all accounts by working with KOLs, providers, pharmacy, and P\u0026amp;amp;T where appropriate.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated highly effective account management skills and exemplary selling competencies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintains knowledge of Oncology and Rare Disease standards of care and emerging clinical trends, and is able to articulate approved, on-label product information related to these topics.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Compliant\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Refers requests for off-label information to KKNA’s medical department through the MIR process\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strictly adhere to relevant regulatory and compliance guidelines and company policies.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Requirements\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree required.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Experience\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;A minimum of 5 years of pharmaceutical sales experience with a minimum of 3 years of pharmaceutical account management experience.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A minimum of 3 years’ experience within institutional, oncology, or rare disease sales.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven track record of sales success.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Must have a high degree of understanding of the Buy \u0026amp;amp; Bill \u0026amp;amp; Market Access marketplace.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Must have a strong track record of therapeutic area/product knowledge.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Proficient in MS Office Suite and Veeva is a must.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent organizational/communication skills, initiative, and ambition to succeed are all essential.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Valid US Driver’s License\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Non-Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Highly motivated and with great attention to detail. Strong endurance to work under tight timelines and complex/changing situations.\u0026amp;nbsp; Excellent written and oral communication skills including the ability to present via PowerPoint in front of large groups. Excellent problem-solving skills. Broad level of interpersonal skills and flexibility.\u0026amp;nbsp;\u0026amp;nbsp; Cultural sensitivity and ability to develop consensus within a multinational organization.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Physical Demands:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Normal office environment with prolonged sitting and extensive computer work. Extensive driving and potential air travel with overnights are expected in some territories. The ability to safely and successfully operate a motor vehicle is required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;This position will be field based and will require approx. 50% overnight travel depending on territory.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at\u0026amp;nbsp;\u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt;\u0026amp;nbsp;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Annualized base salary ranges from $150,000 – $175,000 plus sales incentive; actual salaries will vary and may be above or below this range commensurate with various factors including but not limited to experience, education, training, and merit.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This position is eligible for a company car through the Company’s FLEET program.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin provides a comprehensive compensation and benefits package which includes:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Medical, Dental \u0026amp;amp; Vision Insurance, Basic and Voluntary Life and AD\u0026amp;amp;D Insurance, Short- and Long-Term Disability Insurance, Flexible Spending Accounts, and Health Savings Account, Business Travel Insurance, Employee Assistance Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Retirement Savings 401k with company match and annual discretionary profit sharing\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work-Life Programs Including Gympass, Nutrition Counseling, , Volunteer Time Off, Flexible Work Arrangements, Parental Leave, Adoption Assistance, and TouchCare Insurance \u0026amp;amp; Billing Support\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous Paid Time Off, Sick Time, \u0026amp;amp; Paid Holidays\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Perks and Discounts with Tickets at Work and LifeMart\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Reward \u0026amp;amp; Recognition Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Career Development and Training\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-PE1\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-Field\u0026amp;nbsp;\u0026lt;/p\u0026gt;","departments":[{"id":4040125003,"name":"Oncology Sales","child_ids":[],"parent_id":4017399003}],"offices":[{"id":4061217003,"name":"Field","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7635833003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5720418003,"location":{"name":"Sanford, NC"},"metadata":null,"id":7635833003,"updated_at":"2026-04-13T16:15:13-04:00","requisition_id":"1336","title":"QA Specialist II - Operations","company_name":"Kyowa Kirin North America","first_published":"2026-02-19T08:19:01-05:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Quality Assurance Specialist Operations II plays a pivotal role in the launch and ongoing operations of the Quality Assurance organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC. Starting in a greenfield environment, you will help establish QA systems and processes, then transition into providing technical leadership through GMP readiness, technology transfer, and facility licensure for late clinical and commercial products.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;You will ensure that all GxP areas within the Site Operations maintain full compliance with current GxP standards and all applicable global, regional, and site procedures within Kyowa Kirin’s Quality Management System. This role offers a unique opportunity to shape a culture of quality from the ground up while contributing to the delivery of life-changing therapies.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Key responsibilities include executing core QA activities such as batch record review, Manufacturing Quality Assurance, QA oversight of warehouse, and incoming quality. You will collaborate cross-functionally to monitor site quality metrics, investigate deviations, and support continuous improvement initiatives. Leveraging the Global Quality Management System, you will ensure alignment with regulatory requirements, including data integrity standards. \u0026amp;nbsp;Through active participation in regulatory inspections and leadership in quality culture initiatives, you will help ensure the site operates with excellence, integrity, and accountability.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role reports into the Senior Manager, Quality Assurance\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Technical Skills, Knowledge, and Experience\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Apply advanced Quality Assurance expertise across GxP operations to support compliant manufacturing and ensure production goals are met.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Perform as Shop Floor QA / Manufacturing QA with presence on the manufacturing floor; able to stand for 3 or more hours.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Independently execute batch record review and approval, participate in Gemba walks, coordinate alarm responses, and conduct logbook audits to uphold operational integrity and regulatory compliance.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Participate in batch disposition and support final product release by verifying documentation and quality standards to enable timely and compliant delivery.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support Warehouse and Incoming Quality activities by ensuring materials meet defined specifications and quality requirements.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Review and approve Change Controls, CAPAs, and Deviations in Veeva to ensure timely execution and alignment with regulatory and quality standards.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Identify and escalate discrepancies or non-compliant entries within the Quality Management System (Veeva), collaborating with process owners to resolve issues and ensure records meet regulatory and internal standards.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Lead investigations of non-conformances, deviations, laboratory exceptions, and other cGMP issues; initiate CAPAs and communicate resolution plans to drive effective compliance.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Monitor and analyze site quality metrics—including Deviations, CAPAs, Change Controls, Equipment Failures, EM data trends, and Product Disposition Cycle-times to identify trends, support continuous improvement, and ensure compliance.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Review and approve procedures within Veeva, leveraging the global, regional, and local SOPs to ensure consistency and regulatory alignment.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Champion a culture of quality in all GxP areas within the Site Operations by providing subject matter expertise focused on patient-centric practices, sustainable compliance, and inspection readiness.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Participate in regulatory inspections by demonstrating site compliance and contributing to Quality Assurance activities.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Develop, monitor, and communicate progress against goals across functions, to the Site Leadership Team, and to key stakeholders to ensure alignment and accountability.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure compliance with current regulatory requirements for Data Integrity (ALCOA+) as applicable to paper and electronic records, including 21 CFR Part 11.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Individual contributor, with responsibility to lead or work with cross-functional project teams.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Education\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Bachelor’s degree in a technical or scientific discipline (e.g., Chemical Engineering, Chemistry, Biology, or related field) preferred, with a minimum of 2 years relevant experience in biopharmaceutical manufacturing also preferred.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Associate degree in a technical field and a minimum of 3 years of relevant experience in biopharmaceutical manufacturing.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;High school diploma or equivalent and a minimum 4 years of relevant experience in biopharmaceutical manufacturing.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience with start-up and operation of biopharmaceutical manufacturing processes is a plus.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Experience\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;At least 2 years of experience in a GxP regulated environment, with a focus on batch record review, batch disposition, Shop Floor QA, Manufacturing Quality Assurance, and/or Incoming Quality Assurance.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Performed QA batch disposition and final product release by verifying documentation accuracy and ensuring alignment with regulatory standards.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Reviewed and approved batch records, conducted Gemba walks, responded to alarms, and audited logbooks to maintain operational integrity and ensure compliance.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Reviewed and approved Change Controls, CAPAs, and/or Deviations, ensuring timely resolution and alignment with quality and regulatory expectations.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Performed investigations of non-conformances, deviations, and laboratory exceptions; initiated and followed through on CAPAs to ensure effective resolution.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Participated in regulatory inspections by demonstrating site compliance and executing QA activities aligned with inspection-readiness standards.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience using an Electronic Document Management System in the area of Document Management, Deviation, CAPA, Training, and/or Change Control.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Executed daily QA operations at the manufacturing site while collaborating cross-functionally to drive compliance and continuous improvement.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proficient in MS Office Suite.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proficient in using an Electronic Document Management System for documentation, workflow management, and compliance tracking.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Non-Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Results-oriented and able to navigate ambiguity.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ability to stand for 3 or more hours while on the shop floor.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ability to work a 2-2-3 schedule where each shift is 12 hours in length. \u0026amp;nbsp;During construction and commissioning, this position will follow a Monday–Friday day shift schedule. Once the facility is operational, the role will transition to a 2-2-3 day shift (7:00 AM – 7:00 PM). Shift flexibility may be required during production runs.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Respond promptly, take accountability, and manage tasks efficiently.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Communicate with care by actively listening and considering others\u0026#39; perspectives, fostering productive, engaging interactions, and managing relationships with kindness.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Contribute positively by recognizing achievements and encouraging a healthy work-life balance.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This position is an on-site and on the manufacturing floor\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be\u0026amp;nbsp;\u0026lt;strong\u0026gt;$40.48 per/hr to $49.47 per/hr.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company matching\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long-Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Service\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-JC1\u0026lt;/p\u0026gt;","departments":[{"id":4017396003,"name":"Quality Assurance","child_ids":[],"parent_id":null}],"offices":[{"id":4053087003,"name":"Sanford","location":"Sanford, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7749294003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5771010003,"location":{"name":"Sanford, NC"},"metadata":null,"id":7749294003,"updated_at":"2026-05-28T12:55:34-04:00","requisition_id":"1403","title":"Quality Engineer, Lead (QS\u0026C)","company_name":"Kyowa Kirin North America","first_published":"2026-05-28T10:17:48-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Kyowa Kirin\u0026amp;nbsp;is\u0026amp;nbsp;a\u0026amp;nbsp;Japanese-based company with\u0026amp;nbsp;a fast-growing global specialty pharmaceutical company that applies\u0026amp;nbsp;state-of-the-art\u0026amp;nbsp;biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease. \u0026amp;nbsp;Our\u0026amp;nbsp;collective\u0026amp;nbsp;goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist,\u0026amp;nbsp;from drug discovery to product development and commercialization.\u0026amp;nbsp;\u0026amp;nbsp;The Sanford site is the first\u0026amp;nbsp;production\u0026amp;nbsp;facility in North\u0026amp;nbsp;America,\u0026amp;nbsp;and\u0026amp;nbsp;we are headquartered in Princeton, NJ, with offices in California\u0026amp;nbsp;and Mississauga, Ontario.\u0026lt;/span\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Summary of Job\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;: \u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;The Quality Engineer Lead is a key individual contributor role with functional Quality authority leading and ensuring quality and compliance during the startup and operation of Kyowa Kirin’s Sanford, NC Greenfield site. For this role, the Quality Engineer Lead will support quality oversite to the following areas: Facilities, Utilities, Maintenance, and Equipment otherwise referred to as FUME, including associated instruments and asset lifecycle systems. This role is responsible for building, implementing, and sustaining Quality Engineering processes that enable GMP operations and long-term regulatory compliance, inspection readiness, and audit defense including interactions with health authorities while ensuring compliant implementation and risk acceptance across FUME and Drug Substance manufacturing processes.\u0026lt;/span\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;This role independently prepares, presents, and defends Quality Engineering approaches and evidence during regulatory inspections, internal audits, and external audits.\u0026lt;/span\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;As an individual contributor, you will take a compassionate and people-focused approach to your work\u0026amp;nbsp;while\u0026amp;nbsp;collaborating\u0026amp;nbsp;with other\u0026amp;nbsp;functional groups,\u0026amp;nbsp;both internal\u0026amp;nbsp;and external,\u0026amp;nbsp;to create a supportive and inclusive environment\u0026amp;nbsp;that\u0026amp;nbsp;align\u0026amp;nbsp;with the organization’s values.\u0026amp;nbsp;Strong interpersonal skills,\u0026amp;nbsp;acknowledging\u0026amp;nbsp;diverse\u0026amp;nbsp;viewpoints,\u0026amp;nbsp;and\u0026amp;nbsp;building\u0026amp;nbsp;cross functional\u0026amp;nbsp;relationships\u0026amp;nbsp;will be the\u0026amp;nbsp;key driver\u0026amp;nbsp;to\u0026amp;nbsp;make decisions that meet both individual and team needs.\u0026amp;nbsp;Key drivers for this role\u0026amp;nbsp;require\u0026amp;nbsp;accountability/ownership\u0026amp;nbsp;for delivering results\u0026amp;nbsp;and completing tasks, adapting to challenges\u0026amp;nbsp;while\u0026amp;nbsp;taking the initiative\u0026amp;nbsp;to problem solve\u0026amp;nbsp;with opportunities to grow,\u0026amp;nbsp;helping achieve business goals\u0026amp;nbsp;and\u0026amp;nbsp;keeping\u0026amp;nbsp;the patient\u0026amp;nbsp;first.\u0026lt;/span\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;Reporting Relationship:\u0026lt;/span\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;This position reports to the Sr. Manager, Quality\u0026amp;nbsp;Systems\u0026amp;nbsp;\u0026amp;amp; Compliance.\u0026lt;/span\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;Essential Functions\u0026lt;/span\u0026gt;:\u0026lt;/span\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Technical Skills, Knowledge, and Experience \u0026lt;/span\u0026gt;\u0026lt;/strong\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;•    Act as the Quality Engineering lead for the Sanford site, owning priorities and outcomes and\u0026amp;nbsp;establish\u0026amp;nbsp;clear standards, workflows, and governance to ensure consistency and sustainability as the site grows. \u0026lt;/span\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;•    Lead and provide Quality oversight of GMP readiness activities for facility startup, including equipment, utilities, facilities, and process validation and documentation generation.\u0026lt;/span\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;•    Sustain compliance through lifecycle management of FUME systems, continuous improvement, and ongoing inspection readiness; confirm readiness of systems by reviewing evidence such as drawings, P\u0026amp;amp;IDs, validation deliverables, and turnover packages to ensure fitness for intended use. \u0026lt;/span\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;•    Drive structured problem solving for issues related to equipment, utilities, facilities, instruments, PMs, and calibrations and contribute to the creation of the Preventative Maintenance (PM) and calibration programs, including review of plans, intervals, and criticality assessments.\u0026lt;/span\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;•    Execute and/or provide quality technical leadership\u0026amp;nbsp;of\u0026amp;nbsp;change controls and risk assessments (e.g., FMEA, hazard analysis), including defining risk strategy, ensuring\u0026amp;nbsp;appropriate mitigation, and approving risk acceptance decisions of FUME systems. \u0026lt;/span\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;•    Drive structure problem-solving for issues related to equipment, utilities, facilities, calibrations, and PMs and ensure all activities are consistent with data integrity expectations, Part 11 requirements, and ALCOA++ principles.\u0026lt;/span\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;•    Partner with Engineering, Validation, and Maintenance Teams to\u0026amp;nbsp;maintain\u0026amp;nbsp;inspection-ready documentation and asset status and work collaboratively across teams to support startup activities and ensure compliant execution.\u0026lt;/span\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;•    Review and approve work orders, CQV protocols and reports, change controls, deviations and CAPAs associated with FUME systems, and serve as the Quality lead for FUME related internal, external, and regulatory audits, including inspection preparation, execution, and follow-up. \u0026lt;/span\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Non-Technical Skills\u0026lt;/span\u0026gt;\u0026lt;/strong\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Results-oriented and able to navigate ambiguity. Demonstrates the ability to set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational\u0026amp;nbsp;objectives. Responds promptly, takes accountability, and manages tasks efficiently. Adapts to change with clarity, patience, and understanding while influencing peers and key stakeholders through evolving challenges. In this role, you will\u0026amp;nbsp;exhibit\u0026amp;nbsp;strong organizational skills, attention to detail, and a solid work ethic while\u0026amp;nbsp;demonstrating\u0026amp;nbsp;cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others\u0026#39; perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing,\u0026amp;nbsp;maintaining\u0026amp;nbsp;a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.\u0026lt;/span\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Individual contributor, with responsibility to lead cross-functional project teams and provide Quality governance and influence decision making across FUME related initiatives. \u0026lt;/span\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;Job Requirements:\u0026lt;/span\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;Education\u0026lt;/span\u0026gt;\u0026lt;/strong\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;•    Bachelor’s degree in engineering\u0026amp;nbsp;or science related field\u0026amp;nbsp;required.\u0026lt;/span\u0026gt;\u0026amp;nbsp;\u0026lt;br\u0026gt;\u0026lt;span data-contrast=\u0026quot;auto\u0026quot;\u0026gt;•    Master’s degree in engineering or science related field considered a plus.\u0026lt;/span\u0026gt;\u0026lt;span data-ccp-props=\u0026quot;{}\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Experience\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;•\u0026amp;nbsp; \u0026amp;nbsp; Minimum 8 plus years of direct industry experience in a GxP-regulated environment with a focus on Quality Engineering; including demonstrated experience serving as a Quality SME during regulatory inspections and/or audits.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Demonstrated experience in qualification, validation, change control, and Quality Engineering activities.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Direct experience with PM and Calibration systems, equipment lifecycle management, or CMMS platforms highly preferred\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Familiarity with DS single-use biologics operations or greenfield startup environments is preferred.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;br\u0026gt;Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;br\u0026gt;This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.\u0026lt;br\u0026gt;This role may require travel up to 5% domestic and typically limited international travel.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be\u0026amp;nbsp;\u0026lt;strong\u0026gt;$129,000 to $177,300.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company matching\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long-Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Service\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-JC1\u0026lt;/p\u0026gt;","departments":[{"id":4063732003,"name":"Engineering","child_ids":[],"parent_id":4051418003}],"offices":[{"id":4053087003,"name":"Sanford","location":"Sanford, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7693438003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5747832003,"location":{"name":"Princeton, New Jersey"},"metadata":null,"id":7693438003,"updated_at":"2026-04-10T08:43:40-04:00","requisition_id":"1387","title":"Senior Director, GRA Development \u0026 Product Strategy Team Lead (Bone \u0026 Mineral)","company_name":"Kyowa Kirin North America","first_published":"2026-04-10T06:46:17-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior Director, GRA Development \u0026amp;amp; Product Strategy Team Lead is responsible for the developing and implementing regulatory strategies, while leading people amd managing global projects. This role oversees a team of Global Regulatory Leads (GRL) supporting global products and may serve as a Regional Regulatory Lead (RRL) based on business needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Define and drive global regulatory strategies for all products within the assigned disease area, ensuring alignment with enterprise objectives and maximizing product value.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Lead and develop a team of Global Regulatory Leads (GRLs), setting direction, building capabilities, and fostering a high-performance, accountable culture.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Shape and integrate regulatory strategy into global product development and lifecycle plans in close partnership with cross-functional stakeholders.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Oversee and ensure execution of regulatory strategies, including global submissions, approvals, and post-approval activities across assigned products and projects.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Direct and represent the organization in interactions with health authorities, including leading negotiations and overseeing agency meeting strategy and execution.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Guide and approve global regulatory submission plans, including marketing applications, labeling (e.g., CCDS), and key lifecycle deliverables.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Manage and coordinate regulatory activities, timelines, and deliverables across internal teams and external partners, ensuring alignment and on-time execution.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure compliance with global regulatory requirements, internal policies, and GxP standards, including support for inspections, audits, and governance processes.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Assess and communicate regulatory risks, emerging trends, and competitive intelligence, escalating issues and recommending mitigation strategies as appropriate.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Drive operational excellence by leading process improvements, standardization efforts (e.g., SOPs/WIs), and adoption of best practices across Regulatory Affairs.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Oversee external partnerships and due diligence activities, including vendor selection, alliance management, and regulatory support for business development transactions.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Contribute to organizational leadership, including participation in RA Functional Teams (RAFTs), budget oversight, and fostering collaboration across Regulatory Affairs and the broader organization.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Establish and maintain global labeling strategy, including oversight of Company Core Data Sheet (CCDS) development and alignment with regional labeling requirements.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Allocate and optimize regulatory resources across the portfolio, ensuring effective prioritization and support for key business objectives.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Recruit and build organizational capability by leading talent acquisition, succession planning, and ongoing training initiatives within the regulatory function.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure alignment with Vision 2030, company Core Values, Kabegoe Principles, and the Global Regulatory Affairs Vision.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Education\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline required. \u0026amp;nbsp;Advanced degree (e.g., MS, PhD, PharmD, MBA) is preferred but not required; relevant industry experience may be considered in lieu of advanced education.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Experience\u0026lt;/em\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Minimum 12+ years extensive regulatory affairs experience within the pharmaceutical, biotechnology, or related industry, including global development and lifecycle management, with a focus on bone and mineral disease areas.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proven leadership experience, including managing and developing high-performing regulatory teams and/or leading through other leaders (e.g., GRLs)\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Demonstrated success in developing and executing global regulatory strategies across multiple regions and product stages (development through post-approval)\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Significant experience interacting with health authorities, including leading regulatory agency meetings and negotiations\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Cross-functional leadership experience, with a strong track record of influencing stakeholders and driving alignment across complex, matrixed organizations\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience supporting business development activities, including regulatory due diligence for in-licensing, out-licensing, or partnerships Strong collaboration across cross-functional teams including regulatory affairs, government affairs, clinical, legal, and R\u0026amp;amp;D.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;em\u0026gt;Technical Skills\u0026lt;/em\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Deep knowledge of global regulatory frameworks and guidelines, including major markets (e.g., FDA, EMA, ICH,PMDA) and their application to drug development and lifecycle management\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Expertise in regulatory submissions and approvals, including INDs/CTAs, NDAs/BLAs/MAAs, and post-approval variations\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Strong understanding of global labeling requirements, including development and maintenance of Company Core Data Sheets (CCDS)\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Advanced regulatory strategy development and risk management skills, with the ability to anticipate challenges and drive solutions\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Familiarity with GxP requirements and regulatory compliance standards, including inspection and audit readiness\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proficiency in regulatory systems, tools, and document management platforms used for submissions, tracking, and compliance\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Strong organizational and project management skills with the ability to manage multiple initiatives simultaneously.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Exceptional communication and influencing skills, with the ability to clearly articulate complex regulatory strategies, risks, and requirements to diverse audiences, including health authorities, senior leadership, and cross-functional teams, to drive alignment and informed decision-making.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Strong proficiency MS Office Suite.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Working Conditions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Requires up to domestic and international travel.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be \u0026lt;strong\u0026gt;$265,000-$285,000\u0026lt;/strong\u0026gt;. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company match\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Services\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-TT1 #Hybrid #Princeton\u0026lt;/p\u0026gt;","departments":[{"id":4017397003,"name":"Regulatory Affairs","child_ids":[],"parent_id":null}],"offices":[{"id":4010013003,"name":"Princeton","location":"Princeton, New Jersey, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7726597003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5761178003,"location":{"name":"Sanford, NC"},"metadata":null,"id":7726597003,"updated_at":"2026-05-06T16:55:23-04:00","requisition_id":"1396","title":"Senior Maintenance and Utilities Technician","company_name":"Kyowa Kirin North America","first_published":"2026-05-06T16:55:23-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As the Senior Maintenance and Utilities Technician, this role ensures the reliable operation and maintenance of facility utilities and equipment at our biopharmaceutical manufacturing site by applying advanced expertise in GMP, regulatory compliance, and technical troubleshooting. You manage complex projects, mentor other technicians, and implement best practices to enhance team performance and efficiency. By proactively addressing maintenance needs and minimizing downtime, you maintain a clean, safe, and compliant production environment.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role reports into the Manager, Maintenance and Utilities\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Technical Skills, Knowledge, and Experience\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Perform scheduled inspections, preventive maintenance, and corrective repairs on bioprocessing equipment such as bioreactors, centrifuges, and filtration units to ensure optimal performance and reliability.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Execute preventive and corrective maintenance on facility utilities, including boilers, chillers, air compressors, WFI water systems, HVAC systems, and other critical infrastructure as required.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proactively diagnose complex equipment malfunctions, conduct timely repairs, and implement long-term solutions to prevent recurrence; escalate unresolved or critical issues to appropriate management or technical experts, providing clear documentation and recommendations.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Demonstrate a strong commitment to safety by adhering to all Environmental, Health, and Safety (EHS) policies and proactively identifying and mitigating potential hazards.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Provide technical support for the start-up, commissioning, and turnover of new systems throughout the site, ensuring seamless integration and compliance.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Maintain accurate and comprehensive maintenance records in compliance with GMP (Good Manufacturing Practices), FDA regulations, and audit requirements.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate closely with process engineers, quality assurance, manufacturing staff, and other cross-functional teams to resolve technical issues and support operational goals.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Mentor and provide technical guidance to other technicians and contractors, fostering knowledge sharing and professional development.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Document root causes of equipment failures and recommend effective, long-term solutions to enhance reliability and efficiency.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Plan and execute site shutdowns effectively, ensuring minimal disruption to operations while maintaining safety, compliance, and schedule adherence.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Individual contributor, with responsibility to lead or work with cross-functional project teams.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Education/Experience\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp; \u0026amp;nbsp;•\u0026amp;nbsp; \u0026amp;nbsp; High School Diploma with 3-5 years relevant experience.\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Associates/Bachelor’s Degree and 1-3 years of relevant experience.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Demonstrate proficiency in CMMS platforms such as D365 EAM, SAP PM, Maximo, or equivalent systems to manage calibration schedules, documentation, and asset history.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate effectively with internal stakeholders and service partners to deliver high-quality, customer-focused calibration and maintenance solutions.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Communicate clearly and professionally, both verbally and in writing, to ensure accurate documentation and effective coordination across teams.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Apply strong organizational skills and attention to detail to maintain data integrity, ensure compliance, and achieve audit readiness.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Demonstrated ability to develop, coordinate, and execute planned shutdowns, ensuring adherence to timelines, safety protocols, and operational requirements.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Non-Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Results-oriented and able to navigate ambiguity.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Respond promptly, take accountability, and manage tasks efficiently.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Communicate with care by actively listening and considering others\u0026#39; perspectives, fostering productive, engaging interactions, and managing relationships with kindness.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Contribute positively by recognizing achievements and encouraging a healthy work-life balance.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Physical Demands:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Must be able to work in a regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Requires up to 5% of domestic travel, based on business needs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;This position follows a Monday–Friday day shift (8AM to 4:30 PM).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;This position is designated as essential to site operations, as such the employee may be required to report to the facility or remain on-site during certain operational or emergency situations to ensure business continuity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;On-call availability may be required to support urgent operational needs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Must be able to perform the physical requirements of the role, including occasionally lifting to 50 lbs; Reasonable accommodation will be provided as required by law.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Regularly works in environments with exposure to machinery, noise, and physical hazards. Appropriate personal protective equipment (PPE) is required at all times.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be\u0026amp;nbsp;\u0026lt;strong\u0026gt;$35 to $48 per/hour.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company matching\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Discretionary Profit Sharing\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long-Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Service\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-JC1\u0026lt;/p\u0026gt;","departments":[{"id":4063734003,"name":"Maintenance","child_ids":[],"parent_id":4051418003}],"offices":[{"id":4053087003,"name":"Sanford","location":"Sanford, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7724465003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5760374003,"location":{"name":"Sanford, NC"},"metadata":null,"id":7724465003,"updated_at":"2026-05-05T08:42:26-04:00","requisition_id":"1393","title":"Senior MSAT Engineer (Upstream)","company_name":"Kyowa Kirin North America","first_published":"2026-05-05T08:38:38-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary of Job\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior MSAT Engineer will play a critical role in providing technical leadership for the technical transfer, manufacturing, and testing of clinical and commercial drug substances. The position requires a deep understanding of monoclonal Antibody (mAb) manufacturing processes and bioanalytical assays to ensure monitoring, troubleshooting and continuous improvement at the new Kyowa Kirin North America mAb drug substance manufacturing facility in Sanford, NC.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role plays a critical role in facilitating the transfer of clinical and commercial drug substance manufacturing from other Kyowa Kirin sites or CMOs. Collaborating with internal and external teams, this role will drive the development of robust manufacturing processes and ensure seamless technology transfers. With deep expertise in mAb drug substance manufacturing and analytical methods, the Senior MSAT Engineer will lead transfer efforts for both new and existing products, ensuring efficiency, compliance, and operational readiness.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;strong\u0026gt;Essential Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Technical leadership\u0026lt;/strong\u0026gt;: Provide technical knowledge and insight, project management, and leadership for the commercialization of mAb drug substances.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Process management:\u0026lt;/strong\u0026gt; Lead the transfer of drug substance processes to and from the manufacturing facility. Evaluate and optimize processes to improve efficiency and quality.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Troubleshooting:\u0026lt;/strong\u0026gt; Lead investigations and perform troubleshooting following process deviations, trends, or issues. This includes designing and performing small-scale experiments/studies in lab to support technology transfer or investigations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Design of Experiments (DoE):\u0026lt;/strong\u0026gt; Plan, conduct, and analyze DoE using appropriate statistical tools to drive process optimization and problem-solving.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Change Control:\u0026lt;/strong\u0026gt; Create and implement corrective actions utilizing the site’s change control process.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Collaboration and Alignment:\u0026lt;/strong\u0026gt; Collaborate and align with Global R\u0026amp;amp;D and CMC, CDMOs, Process Engineering, Manufacturing, QA, QC to ensure processes are transferred and maintained effectively.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Documentation:\u0026lt;/strong\u0026gt; Author and review technical reports, process transfer summaries, and other documents. Review manufacturing batch records and provide technical inputs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Trending/Reporting: \u0026lt;/strong\u0026gt;Maintain process databases and monitor batch-to batch consistency of operations. Support preparation of Continued Process Verification and Annual Product Reviews\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Compliance:\u0026lt;/strong\u0026gt; Ensuring that changes to processes and methods are documented and carried out in compliance with cGMP requirements. Write change controls, perform impact assessment, and collaborate with QA and manufacturing on establishment and execution of change action plan.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Reporting and Presentations:\u0026lt;/strong\u0026gt; Design, develop, and execute relevant project status and data reporting, lead discussions regarding investigations, and facilitate alignment in individual and group settings.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Education\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;BS, MS or PhD in Pharmaceutical Sciences, Engineering or related Life Sciences is required (MS/PhD preferred).\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Experience\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Experience with MSAT, Process development, Process engineering, Tech transfer preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Minimum 5 years of experience with purification in the biotech industry.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Industry experience in mAb upstream/cell culture and harvest process preferred\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Direct experience in technical transfer (Process scale-up and site-to-site transfer) in the biotech industry.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with deviation, investigation, RCA, CAPA, and continuous process monitoring\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated project management skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent analytical and communication abilities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Good understanding of Good Manufacturing practices and applicable regulations (e.g., ICH regulations).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with starting up and operating a biopharma manufacturing facility is a plus.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Process and analytical skills\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Expertise in bench-scale mAb upstream operations and the use of bioanalytical instruments.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficient in statistical analysis and DoE to optimize process parameters.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced competency in MS Office Suite for data management and reporting.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Non-Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;Results-oriented and able to navigate ambiguity, you set clear outcomes, track progress, follow through on commitments, and ensure your actions lead to measurable results that advance organizational objectives. Respond promptly, take accountability, and manage tasks efficiently. Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges. Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment. Communicate with care by actively listening and considering others\u0026#39; perspectives, fostering productive, engaging interactions, and managing relationships with kindness. Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset. Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment. Contribute positively by recognizing achievements and encouraging a healthy work-life balance. Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain. Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions. Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Initially working on a construction site and ultimately in a biotech manufacturing site in Sanford, NC.\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;\u0026lt;strong\u0026gt;Work is 100% on-site. \u0026amp;nbsp;This is not a hybrid or remote role. \u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Working Conditions: Requires up to 50% domestic and international travel,\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be\u0026amp;nbsp;\u0026lt;strong\u0026gt;$135,000 to $155,000.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company matching\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Discretionary Profit Sharing\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long-Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Service\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-PE1\u0026lt;/p\u0026gt;","departments":[{"id":4051418003,"name":"Manufacturing","child_ids":[4063734003,4063732003,4063733003],"parent_id":null}],"offices":[{"id":4053087003,"name":"Sanford","location":"Sanford, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7726370003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5761092003,"location":{"name":"Sanford, NC"},"metadata":null,"id":7726370003,"updated_at":"2026-05-07T14:55:32-04:00","requisition_id":"1395","title":"Specialist II, Quality Control - Microbiology","company_name":"Kyowa Kirin North America","first_published":"2026-05-07T14:55:32-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Summary of Job:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The\u0026amp;nbsp;\u0026lt;strong\u0026gt;Specialist II, Quality Control Microbiology\u0026lt;/strong\u0026gt;\u0026amp;nbsp;plays a key role in establishing and executing microbiological testing activities within the QC organization at Kyowa Kirin’s new monoclonal antibody drug substance manufacturing facility in Sanford, NC. This position begins in a greenfield environment and evolves through GMP readiness, technology transfer, and facility licensure for Phase III and early commercial products.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;You apply technical knowledge to routine and moderately complex microbiological tasks, collaborate across functions, and begin demonstrating independent problem-solving. Responsibilities include executing microbiological methods, maintaining compliance with current GxP standards, and ensuring alignment with global, regional, and site-specific procedures within Kyowa Kirin’s Quality Management System. This role is essential to building a reliable, compliant, and science-driven QC Microbiology function that supports the broader manufacturing and quality strategy.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As an individual contributor, you will take a compassionate and people-focused approach to your work. You will proactively collaborate with others to create a supportive and inclusive environment, always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Reporting Relationship: Senior Manager, Quality Control\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Essential Functions:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Technical Skills, Knowledge, and Experience:\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Perform routine and moderately complex microbiological tasks to enable QC operations and contribute to business processes. Collaborate cross-functionally during early-stage site activities, including identifying user requirements and prioritizing implementation of equipment, instruments, analytical methods, and electronic quality systems (e.g., LIMS, ELN, LES).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Execute and assist in the qualification and transfer of compendial and non-routine microbiological methods in accordance with GxP standards, SOPs, and specifications. Techniques include bioburden (TAMC/TYMC), bacterial endotoxins (LAL), growth promotion, microbial identification, and rapid microbiological methods.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Apply working knowledge of sampling, culturing, microscopy, and aseptic techniques across a variety of sample types (e.g., water, air, gases, raw materials, surfaces, in-process, drug substance, stability, investigations).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to the development and maintenance of site-specific QC procedures within the global Veeva electronic Quality Management System (QMS) to enable operational readiness of the Microbiology Laboratory.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in Site Risk Management activities, documenting risk-based decisions using compliant methodologies and supporting data. Collaborate with peers to apply risk principles in daily QC operations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Implement GxP procedures related to the Environmental and Utility Monitoring Program and Contamination Control Strategy in coordination with cross-functional teams.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Train and qualify team members in microbiological methods and contamination control practices. Assist in onboarding junior staff and contractors per approved staffing plans.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist with utilities qualification and environmental monitoring performance qualification (EMPQ) to ensure facility readiness and alignment with production goals.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review validation and qualification documentation for facility systems, microbiological instruments, and computerized systems to confirm commissioning and operational readiness.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate and perform sampling and testing activities. Review QC laboratory results for accuracy and completeness under moderate supervision.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain core lab operations, including gowning protocols, personnel and material flow, sample handling, inventory management, lab safety, waste disposal, and cleaning procedures.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prepare and contribute to laboratory reports, including microbial trend reports, EM/UM recoveries, excursion reports, OOS, and invalid assay documentation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with Operations, Quality Assurance, and Compliance teams to align QC Microbiology activities with global and regional policies and inspection readiness expectations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Participate in investigations of non-conformances, deviations, and laboratory exceptions. Assist in drafting and implementing corrective and preventive actions (CAPAs).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Monitor and report key performance indicators (KPIs) for Site Quality Metrics, including deviations, CAPAs, change controls, OOS, invalid assays, OOT, equipment failures, EM data trends, stability trends, and product disposition cycle times.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrate ownership of assigned tasks and contribute technical input to build a reliable, compliant, and science-driven QC Microbiology function aligned with Kyowa Kirin’s manufacturing and quality strategy.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Track progress against individual and team goals and communicate updates to the Site Leadership Team and key stakeholders.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Subordinates: Individual Contributor with responsibility to lead or work with cross-functional project teams.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Job Requirements:\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree in Microbiology, Biotechnology, or a related Life Sciences discipline required.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Master’s degree or graduate-level studies preferred.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Experience\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Minimum of 2 to 4 years of experience in a Quality Control Microbiology laboratory, providing technical and compliance expertise within GxP-regulated biopharmaceutical manufacturing operations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience investigating microbial contamination incidents, laboratory non-conformances (e.g., OOS), and interpreting data within the framework of Quality Management Systems (QMS), laboratory controls, and applicable regulatory standards.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience contributing to the start-up of a QC Microbiology laboratory in a new facility is a plus.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Familiarity with engineering and GxP documentation related to equipment, facilities, and process qualification efforts (e.g., validation protocols, reports, test plans, verification plans, validation master plans, site master file) is also preferred.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Proficient in MS Office Suite, and Lean Labs or Agile Lean.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Non-Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Results-oriented and able to navigate ambiguity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Respond promptly, take accountability, and manage tasks efficiently, and adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Communicate with care by actively listening and considering others\u0026#39; perspectives, fostering productive, engaging interactions, and managing relationships with kindness.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset and promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute positively by recognizing achievements and encouraging a healthy work-life balance and collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Apply an enterprise-wide, holistic mindset, working beyond siloed thinking to deliver cohesive, integrated solutions.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Results-oriented and able to navigate ambiguity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives and respond promptly, take accountability, and manage tasks efficiently.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges and exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Communicate with care by actively listening and considering others\u0026#39; perspectives, fostering productive, engaging interactions, and managing relationships with kindness.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset and promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute positively by recognizing achievements and encouraging a healthy work-life balance and collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Resourceful and proactive, challenge the status quo, drive innovation, and develop creative solutions.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Physical Demands:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Initially this position requires working on a construction site and ultimately in a biotech manufacturing laboratory. Must be able to work in an office and regulated manufacturing environment, including construction/start-up phases. During the construction and start-up phases, employees may be required to wear appropriate personal protective equipment (PPE), including hard hats, safety glasses, steel-toe boots, and high-visibility vests. Once transitioned to the GMP laboratory environment, PPE will include lab coats, gloves, safety goggles, and other gear as defined by site safety protocols. \u0026lt;strong\u0026gt;This position is based on-site in Sanford, NC. Work is 100% on-site. Other standard company policies for flexible work arrangements do not apply to this role.\u0026lt;/strong\u0026gt; \u0026lt;strong\u0026gt;This is not a hybrid or remote role\u0026lt;/strong\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Working Conditions: Requires up to 10% domestic and limited international travel. Travel to Japan may be required for training and qualification activities during technology transfer process.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be\u0026amp;nbsp;$76,200 to $104,800. \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company matching\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long-Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Service\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#L!-JC1\u0026lt;/p\u0026gt;","departments":[{"id":4051418003,"name":"Manufacturing","child_ids":[4063734003,4063732003,4063733003],"parent_id":null}],"offices":[{"id":4053087003,"name":"Sanford","location":"Sanford, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7728440003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5762278003,"location":{"name":"Sanford, NC"},"metadata":null,"id":7728440003,"updated_at":"2026-06-01T09:04:57-04:00","requisition_id":"1399","title":"Sr. Manager, Supply Chain","company_name":"Kyowa Kirin North America","first_published":"2026-05-08T11:35:13-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior Manager, Supply Chain is responsible for leading Supply Chain at the Sanford Manufacturing Site. The Senior manager will ensure the reliable and efficient supply of clinical and commercial drug products to regional \u0026amp;amp; global supply chains. This role is a key contributor to the planning team (locally, regionally and globally); supporting all aspects of materials management, product supply and inventory management, enabling the extraction of business insights from data, establishing and evaluating key performance indicators, and using continuous improvement methodologies to improve the overall process robustness of the supply chain. This role will be responsible for supporting the management of Drug Substance supply and inventory, associated activities within our ERP/MRP, demand, capacity, serialization, and inventory management systems (Plan/Source/Make/Deliver) and is a functional subject matter expert in the related processes. The Senior Manager, Supply Chain leads product operations including Warehouse and Distribution site operations using digital \u0026amp;amp; team facilitation capabilities to ensure the reliable flow of products.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential Functions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Represents the Sanford Manufacturing Site in the monthly demand/supply planning processes (S\u0026amp;amp;OE, S\u0026amp;amp;OP, etc).\u0026lt;br\u0026gt;• Develops and optimizes inventory strategies for KKNC products and owns business processes related to supply chain execution via ERP/MRP functionality.\u0026lt;br\u0026gt;• Responsible for master data management for direct materials, inclusive of Bill of Materials maintenance for existing \u0026amp;amp; launch products.\u0026lt;br\u0026gt;• Assists in the facilitation of the Requisition to Pay processes related to ongoing management of the business\u0026lt;br\u0026gt;• Develop and govern the process through which production schedules are developed and managed within the value streams, including prioritization logic, constraint management, process controls, and flex/buffer strategies while achieving company revenue goals, customer service goals, inventory, and lean productivity goals\u0026lt;br\u0026gt;•\u0026amp;nbsp;Understand and highlight capacity constraints and work collaboratively with Manufacturing on resolution across resources and constraints.\u0026lt;br\u0026gt;•\u0026amp;nbsp;Develop and implement inventory management strategies that support supply plant health \u0026amp;amp; resilience, minimize risk of E\u0026amp;amp;O for both finished goods (manufactured drug substance) and raw materials, while balancing inventory and availability goals.\u0026lt;br\u0026gt;• Uses continuous improvement methodologies to evaluate process gaps, improve cross-functional performance, and elevate efficiency and efficacy.\u0026lt;br\u0026gt;• Develops SOPS, Work Instructions, and Job-Aids to ensure the robustness of planning execution and is the owner of supply chain maps. Leads project management activities for improvement initiatives / strategic initiatives.\u0026lt;br\u0026gt;• Supports the development and management of Sanford Manufacturing Site supply chain needs inclusive of logistics, warehousing, planning, digitization, and supports the annual strategy deployment process and while contributing to the growth of a high-performing team.\u0026lt;br\u0026gt;• Establishes, monitors, and improves business performance metrics and improvement targets to ensure best in class operations are realized\u0026lt;br\u0026gt;•Establishes change management plans inclusive of ERP update deployment, required testing, UAT’s and user adoption activity\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Requirements:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Education\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;Bachelor’s Degree Required, with focus in Supply Chain Management, Industrial Engineering, or other business management subject area or related field.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Experience\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;5+ years direct Supply Chain Management / Operations experience ideally within Life Sciences manufacturing, or highly regulated industry, preferably within a manufacturing site environment.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;em\u0026gt;Technical Skills\u0026lt;/em\u0026gt;\u0026lt;br\u0026gt;•Deep knowledge in planning processes: S\u0026amp;amp;OP, New Product Introduction, Forecasting, Demand, Supply, Material \u0026amp;amp; Inventory Planning\u0026lt;br\u0026gt;•Understanding of Manufacturing site Supply Chain operations, inclusive of Logistics, Packaging, Warehouse Management operations.\u0026lt;br\u0026gt;•High Level of Proficiency using and driving effectivity of ERP, such as SAP, JDE, Preferably MS D365\u0026lt;br\u0026gt;•Proficiency with planning and business insights tools (APO, Kinaxis, O9 Solutions), PowerBI, Qlikview, and legacy business management software (MS Office Suite)\u0026lt;br\u0026gt;•Knowledge of and capability to effectively use continuous improvement / process improvement methodologies and tools (such as LEAN Six Sigma, Toyota Production System)\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Non-Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;•Results-oriented you set clear outcomes, track progress, follow through on commitments and ensure your actions lead to measurable results that advance organizational objectives.\u0026lt;br\u0026gt;•Solutions minded with strong critical thinking \u0026amp;amp; analytical skills\u0026lt;br\u0026gt;•Strong Interpersonal \u0026amp;amp; communication (verbal \u0026amp;amp; written) skills are required.\u0026lt;br\u0026gt;•Risk/Resiliency Modeling \u0026amp;amp; Contingency Planning experience is preferred\u0026lt;br\u0026gt;•Ability to thrive in a matrixed, diverse-culture environment\u0026lt;br\u0026gt;•Action-oriented and accountable, desiring results.\u0026lt;br\u0026gt;•Desires to be part of a High-Performing Team and to promote the development of High-Performing team members.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Physical Demands:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Initially working on a construction site and ultimately in a biotech manufacturing facility in Sanford, NC. Work is 100% on-site. This is not a hybrid or remote role.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Working Conditions:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Requires up to 10% domestic and international travel\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be\u0026amp;nbsp;\u0026lt;strong\u0026gt;$154,400 to $171,600.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company matching\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long-Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Service\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-TT1 #On-Site #Sanford\u0026amp;nbsp;\u0026lt;/p\u0026gt;","departments":[{"id":4017401003,"name":"Supply Chain","child_ids":[],"parent_id":null}],"offices":[{"id":4053087003,"name":"Sanford","location":"Sanford, North Carolina, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7758775003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5775416003,"location":{"name":"Princeton, New Jersey"},"metadata":null,"id":7758775003,"updated_at":"2026-06-03T11:55:00-04:00","requisition_id":"1406","title":"Sr. Medical Director, Global Medical Affairs (Myeloid malignancies)                                                ","company_name":"Kyowa Kirin North America","first_published":"2026-06-03T11:55:00-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This position requires being onsite two days a week in our Princeton, NJ HQ. This is note a remote opportunity.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary of Job:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior Medical Director, Global Medical Affairs – Oncology is responsible for leading the development and execution of global medical affairs strategies for oncology programs, with a focus on myeloid malignancies. This role provides medical and scientific leadership across assigned assets and supports the integration of medical strategies with broader corporate objectives. The incumbent will lead global medical activities related to evidence generation, scientific communication, and external engagement, including collaboration with alliance partners and key external stakeholders. The position works cross-functionally with Clinical Development, Commercial, Regulatory, Market Access, and other internal teams to ensure alignment and effective execution of medical affairs initiatives.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role requires deep expertise in oncology and or hematology, strong strategic and analytical capabilities, and the ability to lead complex, cross-functional initiatives in a global environment.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Essential Functions:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead the development and execution of global medical affairs strategies for assigned oncology assets, including pre-launch planning, lifecycle management, and long-term strategic initiatives focused on myeloid malignancies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as the primary global medical scientific lead for healthcare decision-makers and external stakeholders, facilitating scientific exchange regarding disease state management and the clinical and economic value of oncology products.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate cross-functionally with Clinical Development, Research \u0026amp;amp; Development, HEOR, Market Access, Commercial, Regulatory, and other internal stakeholders to ensure alignment of medical strategies with corporate and portfolio objectives.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead integrated evidence generation strategies and medical data generation plans, including company-sponsored clinical trials, investigator-sponsored studies, and real-world evidence initiatives.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide strategic medical leadership for alliance partnerships by collaborating with partner companies to align on shared medical strategies, evidence generation activities, and external engagement plans across joint oncology programs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee the execution and quality of ongoing medical affairs studies and activities to ensure scientific rigor, compliance with regulatory requirements, and alignment with organizational objectives.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify evidence gaps, emerging scientific trends, and external insights to inform medical strategy, portfolio development, lifecycle planning, and stakeholder engagement activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Build and maintain strategic relationships with key opinion leaders (KOLs), healthcare systems, advocacy organizations, payer organizations, and other external stakeholders globally.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Represent the organization at scientific congresses, advisory boards, investigator meetings, and other external forums to communicate medical and scientific data and support organizational thought leadership in oncology.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate global medical affairs activities with alliance partners and internal stakeholders to support seamless execution of shared medical initiatives and external engagement strategies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide leadership, coaching, and development for direct reports and/or junior medical affairs team members, including performance management, mentoring, and fostering a collaborative, high-performing team culture.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Supervise and manage assigned personnel, consultants, vendors, and external collaborators, as applicable, to ensure effective execution of medical affairs objectives and adherence to company policies and compliance standards.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Job Requirements:\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Medical Doctor. Board certification and/or subspecialty training in Oncology and/or Hematology preferred.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Experience\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Minimum of 10 years of experience in Medical Affairs within the pharmaceutical and/or biotechnology industry, including significant experience in oncology; hematology and/or myeloid malignancy experience strongly preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Combination of Global and Regional/Country Medical Affairs experience strongly preferred, including experience supporting global product strategy and execution.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience developing and executing global medical affairs strategies across multiple stages of the product lifecycle, including pre-launch and post-launch activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven track record of leading cross-functional initiatives and influencing matrixed teams across Medical Affairs, Clinical Development, Commercial, HEOR, Market Access, and Regulatory functions.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience leading evidence generation activities, including company-sponsored studies, investigator-sponsored research, and/or real-world evidence initiatives.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated success engaging with external stakeholders, including key opinion leaders (KOLs), healthcare decision-makers, advocacy organizations, and payer audiences in global markets.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven ability to collaborate effectively with alliance partners, external collaborators, and co-development/co-commercialization partners.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong people leadership capabilities, including mentoring, coaching, and direct management of medical affairs personnel and/or cross-functional teams.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven ability to represent the organization at scientific congresses, advisory boards, investigator meetings, and other external scientific forums.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge of HEOR disciplines, biostatistics, clinical trial design, and evidence-based medicine principles.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exceptional interpersonal, communication, presentation, and organizational skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strategic thinking with demonstrated ability to influence stakeholders across matrix environments.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge of oncology medical affairs, including evidence generation, scientific exchange, and product lifecycle support within global markets.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced understanding of HEOR disciplines, biostatistics, clinical trial design, real-world evidence, and evidence-based medicine principles.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong scientific acumen with the ability to interpret, analyze, and communicate complex clinical and scientific data to diverse stakeholder audiences.\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;Physical Demands:\u0026amp;nbsp;Normal office environment with prolonged sitting and extensive computer work.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Working Conditions: Requires up to 35% domestic and international travel\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be \u0026lt;strong\u0026gt;$256,800 to $335,400.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company match\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Services\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-JC1\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-Hybrid\u0026lt;/p\u0026gt;","departments":[{"id":4091935003,"name":"Global Medical Affairs","child_ids":[],"parent_id":null}],"offices":[{"id":4010013003,"name":"Princeton","location":"Princeton, New Jersey, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/kyowakirinusa90/jobs/7659665003","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"internal_job_id":5729956003,"location":{"name":"Sanford, NC"},"metadata":null,"id":7659665003,"updated_at":"2026-06-01T09:03:45-04:00","requisition_id":"1359","title":"Warehouse Associate II","company_name":"Kyowa Kirin North America","first_published":"2026-03-10T08:26:53-04:00","language":"en","application_deadline":null,"content":"\u0026lt;p\u0026gt;Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.\u0026amp;nbsp; A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As a Warehouse Associate II this individual supports the safe, compliant, and efficient movement of pharmaceutical products and raw materials within the warehouse environment. This role is responsible for receiving, storing, picking, packing, and shipping materials while adhering to strict regulatory requirements, including FDA, cGMP, and company SOPs. The Warehouse Associate plays a key role in maintaining inventory accuracy, ensuring product integrity, and supporting overall warehouse operations.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Receiving \u0026amp;amp; Inventory Management\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Receive incoming raw materials, components, and finished goods; verify accuracy against purchase orders and shipping documents.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Inspect incoming materials for damage, correct labeling, and compliance with specifications.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Accurately record inventory transactions in warehouse management systems (ERP). D365 experience is a plus.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Maintain organized storage areas according to cGMP, FEFO/FIFO, and safety guidelines.\u0026lt;br\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Picking, Packing \u0026amp;amp; Shipping\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Pick and stage materials for production and customer orders following established SOPs.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Package products securely to maintain product integrity and meet quality standards.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Prepare shipping documentation (e.g., packing slips, waybills, BOL).\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Coordinate with carriers to schedule and support outbound shipments.\u0026lt;br\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Regulatory Compliance \u0026amp;amp; Documentation\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Follow all FDA, cGMP, OSHA, and company-specific compliance requirements.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Complete all required logs, forms, and electronic records accurately and in real time.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support internal and external audits through proper documentation and workspace organization.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Material Handling \u0026amp;amp; Equipment\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Operate material-handling equipment such as pallet jacks, forklifts, reach trucks, or order pickers (with proper certification).\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure equipment is maintained in safe working condition and report any issues promptly.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Manage temperature controlled materials, including monitoring and documenting environmental conditions.\u0026lt;br\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;General Warehouse Operations\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Maintain clean and hazard-free work areas in accordance with facility safety standards.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Participate in cycle counts and full physical inventory activities.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate with cross-functional teams including Quality, Manufacturing, and Supply Chain.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Support continuous improvement initiatives to enhance warehouse efficiency and compliance.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Serve as a role model for safety and GMP compliance.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate with Engineering, Automation, and Quality teams to support operational readiness.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Assist with troubleshooting and contribute to continuous improvement initiatives.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Ensure compliance with regulatory standards and adherence to established procedures.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As an individual contributor, you will take a compassionate and people-focused approach to your work, proactively collaborate with others to create a supportive and inclusive environment, and always acting in line with the organization’s values. By using strong interpersonal skills, you will work effectively with diverse viewpoints, manage relationships thoughtfully, and make decisions that meet both individual and team needs. You will be accountable for delivering results, adapting to challenges, and helping achieve business goals. Additionally, you will take ownership of your tasks, act with initiative, and continuously seek opportunities to learn and grow. You will handle change with resilience and clarity, staying flexible in a fast-paced environment while keeping the needs of patients at the center of your efforts.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role reports to the Director, Manufacturing\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Executes warehouse operations in accordance with standard work and work instructions for monoclonal antibody (mAb) production.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Performs all tasks in accordance with Safety and Compliance policies, current Good Manufacturing Practices (cGMP), and Data Integrity principles (ALCOA+), as well as other applicable regulatory requirements.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Escalates any actual or perceived non-compliance events, equipment issues, or process deviations in a timely and appropriate manner.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Identifies opportunities for process improvement and contributes to initiatives that enhance operational efficiency and reduce waste and demonstrates working knowledge of enterprise systems such as ERP, MES, PCS, QMS, and BMS.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Maintains cleanliness and organization of the warehouse area through routine cleaning and preventive maintenance in compliance with GMP and safety standards.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Trains and mentors new team members in warehouse processes, equipment operation, safety procedures, and company standards to support team development and consistency.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Individual contributor\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Education and Experience\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Bachelor’s degree in a technical or scientific discipline (e.g., Chemical Engineering, Chemistry, Biology, or related field) preferred, with relevant experience in biopharmaceutical manufacturing also preferred.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Associate degree in a technical field and at least 2 years of relevant experience in warehousing.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;High school diploma or equivalent and at least 4 years of relevant experience in warehousing.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience with start-up and operation of biopharmaceutical manufacturing processes is a plus.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;3–5 years of warehouse or distribution experience; pharmaceutical, medical device, or other regulated industry preferred.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Basic technical writing skills, such as reviewing or editing SOPs.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Forklift certification and Experience with temperature controlled and/or hazardous materials.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Prior experience in a pharmaceutical manufacturing or distribution facility.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proficient in Microsoft Office applications (e.g., Word, Excel, Outlook).\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Strong problem-solving and critical thinking abilities.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Experience with authoring or editing SOPs is a plus.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Familiarity with ERP, MES, BMS, and PCS systems is preferred.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Maintains clean and compliant warehouse environments in accordance with GMP and safety standards and demonstrates the ability to read and interpret technical documents, troubleshoot basic issues, and operate production equipment.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Proficient in English, with the ability to perform basic math and statistical calculations.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Non-Technical Skills\u0026lt;/strong\u0026gt;\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Results-oriented and able to navigate ambiguity.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Set clear outcomes, track progress, follow through on commitments, and ensure actions lead to measurable results that advance organizational objectives.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Respond promptly, take accountability, and manage tasks efficiently.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Adapt to change with clarity, patience, and understanding, guiding teams through evolving challenges.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Exhibit strong organizational skills, attention to detail, and a solid work ethic while demonstrating cultural sensitivity and the ability to foster alignment in a global environment.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Communicate with care by actively listening and considering others\u0026#39; perspectives, fostering productive, engaging interactions, and managing relationships with kindness.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Embrace personal growth through continuous learning and knowledge sharing, maintaining a growth mindset.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Promote inclusive collaboration by respecting diverse perspectives and creating a welcoming work environment.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Contribute positively by recognizing achievements and encouraging a healthy work-life balance.\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Collaborate with respect, integrity, and humility, prioritizing collective success over individual gain.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;During construction and commissioning, this position will follow a Monday–Friday day shift schedule. Once the facility is operational, the role will transition to a 2-2-3 day shift (7:00 AM – 7:00 PM). Shift flexibility may be required during production runs.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;The role will begin on a construction site and transition to a fully operational biopharmaceutical manufacturing facility in Sanford, NC.\u0026amp;nbsp;\u0026lt;br\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Must be able to safely lift up to 35 lbs. and move heavy objects such as material containers, bagged product, and pallets. Must be able to bend, stoop, navigate operational spaces. Must be able to stand for 3 or more hours while operating equipment.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;This role must seek assistance for all loads that are heavy or awkward and use mechanical devices whenever available. In this role, you should not lift more than 50 pounds without assistance.\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• \u0026amp;nbsp; \u0026amp;nbsp;Must be able to work in a regulated manufacturing environment, including construction/start-up phases, with appropriate PPE. Reasonable accommodation will be provided as required by law.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Requires up to 10% domestic and international travel.\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;This position is based on-site in Sanford, NC. Other standard company policies for flexible work arrangements do not apply to this role. This is not a hybrid or remote role.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The anticipated salary for this position will be\u0026amp;nbsp;\u0026lt;strong\u0026gt;$25 pr/hr to $37.50 pr/hr.\u0026lt;/strong\u0026gt; \u0026amp;nbsp;The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;401K with company matching\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Annual Bonus Program (Sales Bonus for Sales Jobs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;HSA \u0026amp;amp; FSA Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Well-Being and Work/Life Programs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Long-Term Incentive Program (subject to job level and performance)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Life \u0026amp;amp; Disability Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Concierge Service\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Pet Insurance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tuition Assistance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Employee Referral Awards\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at \u0026lt;u\u0026gt;usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. \u0026amp;nbsp;Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at\u0026lt;u\u0026gt; usprivacyoffice@kyowakirin.com\u0026lt;/u\u0026gt;.\u0026lt;/p\u0026gt;\n\u0026lt;h2 class=\u0026quot;jobSectionHeader\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Recruitment \u0026amp;amp; Staffing Agencies\u0026lt;/strong\u0026gt;\u0026lt;/h2\u0026gt;\n\u0026lt;p\u0026gt;Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;#LI-SH1\u0026lt;/p\u0026gt;","departments":[{"id":4051418003,"name":"Manufacturing","child_ids":[4063734003,4063732003,4063733003],"parent_id":null}],"offices":[{"id":4053087003,"name":"Sanford","location":"Sanford, North Carolina, United States","child_ids":[],"parent_id":null}]}],"meta":{"total":25}}