{"jobs":[{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7733235","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":3393440,"location":{"name":"United States"},"metadata":null,"id":7733235,"updated_at":"2026-05-12T14:35:03-04:00","requisition_id":"4462","title":"Director, Apheresis Operations","company_name":"Genetix Biotherapeutics","first_published":"2026-03-18T15:32:26-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Position Description\u0026lt;/strong\u0026gt;:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director, Apheresis Operations, is a leadership role within Patient Operations and is responsible for providing strategic and operational oversight of the apheresis operations team that supports Genetix’s three commercially approved therapies. This role is field based and requires frequent travel to Qualified Treatment Centers (QTC) to engage with our customers and care teams in-person. This role will develop and expand the strategic partnerships and relationships with external partners and evolve the internal team to meet the demands of our growing commercial business. The ideal candidate will enhance and expand on the existing technical and medical knowledge of the organization. The apheresis operations team is a highly skilled and technically knowledgeable group of individuals responsible for: 1) QTC onboarding, training, qualification, 2) data analytics and metric tracking on collections, 3) onsite/remote cell collection support and optimization, and 4) final Drug Product infusion support.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This role partners closely with Manufacturing, Quality, Commercial, Patient Management \u0026amp;amp; Logistics, Medical, and Systems Teams to ensure uninterrupted, world class patient and customer support.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This position is a US Remote position. Domestic travel 50% or more of the time is required for this role.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Duties and Responsibilities\u0026lt;/strong\u0026gt;:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Core Responsibilities\u0026lt;/strong\u0026gt;:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead, engage, evolve, and elevate the Apheresis Operations team to match evolution of our commercial business\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Extensive technical expertise, with strong focus on medical and apheresis operations experience\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Gather and analyze key data metrics, perform KPI tracking to inform continued improvements to our process and patient journey experience\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Field Responsibilities\u0026lt;/strong\u0026gt;:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Travel domestically, 50% or more of the time across our national QTC network for engaging internal and external collection teams, cell therapy labs, treating physicians and teams, and patients as required to provide individualized, white glove customer service and establish partnership with teams involved\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Set the standard of relationship management and communications for the apheresis operations team, provide internal team coaching and field training\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Other Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Serve as subject matter expert for internal and external apheresis education\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with Quality, Technical Development \u0026amp;amp; Operations, and Commercial teams to build a robust treatment center network including center selection, qualification, training and ongoing support\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee and drive the strategy and process improvements for QTC qualification, training, ongoing support\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure compliance with regulatory standards and requirements, oversee management of team owned quality system records, (deviations, CAPAs, change controls, proactive initiatives)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive the identification, sharing, and adaptation of best practices cross-functionally and between centers that will improve overall treatment experience of our patients\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential/Required Qualifications\u0026lt;/strong\u0026gt;:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required\u0026lt;/strong\u0026gt;:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor of Science in Nursing (BSN), Registered Nurse (RN), Qualification in Apheresis (QIA) preferred, or minimally, Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;10+ years of progressive experience in Apheresis Operations, Cell and Gene Therapy, Commercial Operations, Treatment Centers\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prior people leadership experience at the Associate Director or Director level within the industry\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience leading a field-based team, and working in the field\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge of GMP regulations (FDA, EMA, ICH)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Direct apheresis experience within the last 5 years\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Domestic travel, 50% or more of the time\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Passion for bringing curative therapies to patients\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Preferred Qualifications\u0026lt;/strong\u0026gt;:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Experience within Sickle Cell Disease, Beta Thalassemia, and autologous cell and gene therapy\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience working in BioPharma\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Competencies\u0026lt;/strong\u0026gt;:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Primary focus on driving process improvements which have a demonstrable impact on the business\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Enhance apheresis technical knowledge, utilizing this expertise to educate internal and external groups. Key focus on how to improve collections, show up with executive presence at conferences, drive and oversee apheresis summits to be a leader in the industry\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent communication and partnership with internal and external groups and individuals\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Detail oriented, anchor to and utilize data to drive sound business decisions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strategic thinking, with an ability to translate into operational plans\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to adapt to fluctuating relationship dynamics with internal and external partners\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent listening and conflict management skills. Team player, flexible to the needs of a wide range of personalities\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$220,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$276,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":70242,"name":"Patient Supply","child_ids":[],"parent_id":33678}],"offices":[{"id":22344,"name":"US Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7545683","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":3340133,"location":{"name":"Somerville, Massachusetts"},"metadata":null,"id":7545683,"updated_at":"2026-04-29T12:03:57-04:00","requisition_id":"4432","title":"Director of Scientific Communications \u0026 Evidence Generation ","company_name":"Genetix Biotherapeutics","first_published":"2026-01-16T17:17:45-05:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Position Summary:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director of Scientific Communications \u0026amp;amp; Evidence Generation will be responsible for developing a plan for disseminating the company’s scientific data (manuscripts, abstracts, posters, presentations); as well as identifying clinical evidence gaps, overseeing non-registrational research, and collaborating with cross-functional teams to generate real-world evidence (RWE), health economics and outcomes research (HEOR), and investigator-sponsored research (ISR) to support product value and safety profiles. This role requires strong scientific writing skills, advance understanding of industry best practices related to publication-related and research-related compliance, as well as cross-functional leadership savvy.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Responsibilities:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Scientific Communications \u0026amp;amp; Publication Planning\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Develop and maintain and 18-month publication plan and lead the publication review process (abstracts, posters, oral presentations, manuscripts, review articles, etc) in compliance with GPP (Good Publication Practice) and ICMJE authorship criteria, as well as data transparency, and fair balance.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Utilize innovative formats (micro‑learning, interactive pathways, patient‑friendly visuals) and ensure accessibility for diverse audiences\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maximize the scientific impact of company data via the strategic selection of journals and congresses\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Collaborate with internal/external experts\u0026lt;/strong\u0026gt;and vendors to draft content and \u0026lt;strong\u0026gt;ensure the scientific accuracy\u0026lt;/strong\u0026gt; of all data to be presented.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain the enterprise scientific lexicon and core claims matrix; ensure consistency across materials and channels.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Data Generation:\u0026lt;/strong\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead the development of an integrated evidence generation plan (IEGP) aligned with overall medical affairs goals to address unmet needs in collaboration with Clinical Development, Regulatory, HEOR, and Commercial teams to avoid duplicative efforts.\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Evaluate and acquire new data sources (clinical trials, RWD, registries) to support evidence plans.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Create processes for synthesizing feedback from various sources, including field insights and advisory boards and analyze the data to uncover trends and actionable insights to guide scientific communication and strategic decision-making designed to effect change.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Conceptualize and execute non‑promotional education for multidisciplinary audiences (hematology, BMT/transplant, apheresis, transfusion medicine, genetic counseling, nursing), including webinars, symposia, workshops, and digital learning modules.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Establish content measurement frameworks (reach, engagement, knowledge lift, practice intent) and continuous improvement loops.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide operational management for Medical Affairs-led research, including RWE, HEOR, and ISR, including monitoring the contractual commitments of vendors and collaborators to ensure quality and timeline adherence.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure all evidence generation activities follow ICH-GCP guidelines, SOPs, and compliance requirements for post-marketing research.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Cross‑Functional Partnership\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Collaborate within Medical Affairs and with Clinical Development, Regulatory, Pharmacovigilance, Commercial, Market Access, and Patient Advocacy to ensure accuracy and balance across communications.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and deliver scientific training programs for internal teams (e.g., onboarding for MSLs/field medical; refresher modules on gene therapy mechanisms, safety monitoring, LTFU requirements)..\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Associated Responsibilities\u0026lt;/strong\u0026gt;:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Own Med Affairs content as well as related SOPs and work processes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure adherence to policies and procedures via audits.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and deliver monthly and quarterly updates to track progress and align on key priorities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and manage department budget\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead or co‑lead medical review for scientific materials; partner with Legal/Compliance/Regulatory on clear SOPs and guardrails.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;MD, PharmD, PhD in a biomedical field; experience in hematology or Oncology or cell and gene therapy strongly preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;8+ years\u0026lt;/strong\u0026gt; in Medical Affairs/Scientific Communications within biopharma, including publication planning and medical education leadership.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Understanding of hemoglobinopathies (SCD, β‑thalassemia), cell‑based gene therapy modalities, safety monitoring (including long‑term follow‑up), and registry/RWE experience is preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience building omnichannel education programs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Fluency with compliance frameworks (GPP, ICMJE, ACCME, OIG, PhRMA Code) and medical review processes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exceptional scientific writing, editorial judgment, and stakeholder management; comfortable engaging with KOLs, investigators, and advocacy leaders.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$214,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$255,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":33597,"name":"Medical Affairs","child_ids":[],"parent_id":33664}],"offices":[{"id":86122,"name":"Somerville","location":"Somerville, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7953707","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":3453315,"location":{"name":"Somerville, MA"},"metadata":null,"id":7953707,"updated_at":"2026-05-22T09:27:56-04:00","requisition_id":"4486","title":"Director, Pricing, Contracting \u0026 Analytics","company_name":"Genetix Biotherapeutics","first_published":"2026-05-22T07:59:13-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix Biotherapeutics Market Access, Advocacy \u0026amp;amp; Policy team (MAAP) is focused on helping patients access our therapies to deliver on our mission to transform lives through curative therapies for patients with rare, genetic diseases. This committed group is looking for our newest team member to enable authentic, collaborative engagement with the stakeholders and communities that we serve and to support operations across Market Access. Come work with a dedicated, expert group of employees and contribute to a purpose-driven organization that is shaping the future of gene therapy.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;The Director of Pricing, Contracting \u0026amp;amp; Analytics is an individual contributor role within Market Access, with broad ownership across payer contracting, including outcomes-based agreements, government pricing, and analytics. This person is the operational and strategic lead for the company\u0026#39;s payer contract portfolio and is accountable for a set of functions that are compliance-sensitive, deadline-driven, and both strategically and operationally complex. This role requires detailed management and execution, while thinking strategically about contracting and access in a competitive and evolving market. A highly cross-functional position that interfaces regularly with Finance, Legal, Field Payer Team, Patient Services \u0026amp;amp; Channel Operations, payers, external vendor partners, and leadership.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Pricing and Payer Contracting\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Manage payer contracts for gene therapy portfolio for both commercial and government payers and across all stages of the contract lifecycle, including collaboration with cross-functional partners, external stakeholders, and legal counsel\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as the internal subject matter expert on contract terms, payer-specific dynamics, and therapy-specific outcomes to support collaboration with Field Payer Team, Legal, Finance, external vendor partners, and leadership\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop contracting strategies and pricing scenario analysis in response to changes in the treatment and payer landscape\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee compliance of contracts across payer types, including monitoring performance, addressing disputes, and ensuring terms are met\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Government Price Reporting\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Own regular government price reporting obligations in collaboration with third-party vendors and Finance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage pricing events and ensure timely, accurate submissions in compliance with federal and state regulations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain internal documentation to support compliance and audit readiness\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Analytics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Own payer coverage policy landscape analyses for internal teams and external partners\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead payer rebate validation and adjudication, across vendors and internal teams, with accountability for accuracy and support on rebate liabilities and exposure\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and execute gross-to-net modeling, and ad-hoc analytical requests from Finance and leadership\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Vendor Management\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Manage vendor relationships, holding vendors accountable to timelines and deliverables, and escalating issues as needed\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee current vendor workstreams spanning market access strategy and operations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Coordinate vendor activities with cross-functional internal teams to support ongoing business needs\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;strong\u0026gt;Experience:\u0026lt;/strong\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;8+ years of experience in pricing, market access, and payer contracting strategy within the pharmaceutical or biotech industry, including strategy consulting experience.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Expertise in coverage, access, and reimbursement for specialty pharmaceuticals; rare disease, cell and gene therapy and/or hospital-based product experience a plus\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience managing a payer contract portfolio, including contract negotiation, compliance monitoring, and cross-functional support; value-based contracting experience a plus.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Working knowledge of pricing mechanics, including AMP, Best Price, ASP, and government price reporting requirements; hands-on experience preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong business acumen with experience in financial modeling, rebate adjudication, and/or pricing analysis\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience managing external vendors and coordinating across multiple workstreams simultaneously.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Skills \u0026amp;amp; Competencies:\u0026lt;/strong\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Strong sense of urgency, accountability, and patient-centric focus.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent verbal and written communication with high emotional intelligence and active listening.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong quantitative and qualitative analytical, investigative, and critical thinking skills with ability to translate insights into action.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to work independently and manage a high volume of complex, ongoing responsibilities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to navigate sensitive information with discretion and strict adherence to compliance standards.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficiency in Microsoft Excel, Word, PowerPoint, and data entry systems.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Education:\u0026lt;/strong\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree required (preferred fields: Business, Finance, Healthcare Administration, Life Sciences). Relevant advanced degree a plus.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Other Requirements:\u0026lt;/strong\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Ability to work effectively in a fast-paced, evolving environment with competing priorities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Willingness to travel as needed.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$216,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$265,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":70252,"name":"Field Based Teams (AVES)","child_ids":[],"parent_id":33678}],"offices":[{"id":86122,"name":"Somerville","location":"Somerville, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7912663","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":3439955,"location":{"name":"Somerville, MA"},"metadata":null,"id":7912663,"updated_at":"2026-05-12T14:13:25-04:00","requisition_id":"4482","title":"Director, Regulatory Labeling and Advertising Promotion","company_name":"Genetix Biotherapeutics","first_published":"2026-05-11T08:39:58-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Position Description\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Director, Regulatory Labeling, Advertising \u0026amp;amp; Promotion (LAP) is responsible for leading global product labeling and U.S. advertising and promotion regulatory activities across the company’s portfolio. This role provides strategic and operational leadership to ensure labeling and promotional materials are scientifically accurate, compliant with regulatory requirements, and aligned with corporate and commercial objectives.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The position serves as a key regulatory partner to Clinical Development, Medical Affairs, Commercial, Legal, and Safety, and plays a central role in labeling strategy, lifecycle management, and promotional material review in a highly regulated environment, for cell and gene therapy products.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Job Duties and Responsibilities\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Core Responsibilities\u0026lt;/strong\u0026gt;:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Labeling\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead the development, negotiation and lifecycle maintenance of global and US product labeling, including pre- and post- approval updates.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive development and maintenance of Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI), ensuring alignment with global regulatory expectations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Establish and operationalize labeling strategies that result in clear, concise, compliant and scientifically robust product labels.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide regulatory leadership for labeling-related interactions with Health Authorities, including briefing documents and responses to inquiries.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure final labeling content meets internal standards and regulatory authority requirements prior to submission or implementation.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Advertising and Promotion\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Oversee regulatory review of US promotional and select non-promotional materials. across channels, ensuring compliance with FDA regulations and enforcement trends\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as the regulatory lead and reviewer for Medical-Legal-Regulatory (MLR) review.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with Commercial, Medical Affairs and Legal to proactively identify and mitigate regulatory risk in promotional strategy and execution.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Monitor and interpret FDA enforcement actions and policy developments related to advertising and promotion, translating insights into internal guidance and best practices.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop submission strategy for efficient and appropriate health authority review of promotional materials; and ensure the compliant and timely submission of promotional materials to Health Authorities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Create and manage promotional submissions documents in the electronic database and partner with Regulatory Operations on submissions.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Governance, Process and Compliance\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Support or co‑lead the Labeling Review Committee (LRC) and provide regulatory oversight of labeling governance processes.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop, maintain, and improve SOPs, workflows, tools, and training related to labeling and Ad/Prom review.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure inspection readiness and documentation compliance for labeling and promotional activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive consistency and operational excellence across labeling and Ad/Prom processes globally.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Cross-Functional Leadership\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Act as a strategic regulatory advisor to Clinical, Safety, Medical Affairs, Commercial, Quality, and Regulatory Strategy teams.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead and mentor internal staff and manage external vendors or consultants as needed.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to broader regulatory strategy discussions.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Essential/Required Qualifications\u0026lt;/strong\u0026gt;:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Minimum of 10 years of regulatory experience in biotech or pharmaceutical companies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience supporting FDA interactions related to labeling and promotional compliance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with MLR review and developing Company Core Data Sheets\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prior experience in cell and gene therapy or rare disease is strongly preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven ability to lead cross-functional teams and to operate in a matrixed organization, including leadership without direct authority.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent written and verbal communication skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Preferred Qualifications\u0026lt;/strong\u0026gt;:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Prior experience in cell and gene therapy or rare disease is strongly preferred.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to influence without authority and partner effectively with senior leaders.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong attention to detail and accuracy with sound judgement and risk-based decision making.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Entrepreneurial and self-directed, able to prioritize work to meet targets and timelines, motivates others, demonstrates tact and diplomacy, and has a flexible and positive solution-oriented approach.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Key Competencies\u0026lt;/strong\u0026gt;:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Deep understanding of FDA regulations and guidance governing labeling and promotional materials.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;An aptitude for problem-solving and ability to quickly understand new science and technology and to resolve issues and conflicts.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$215,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$253,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":33602,"name":"Regulatory","child_ids":[],"parent_id":33664}],"offices":[{"id":86122,"name":"Somerville","location":"Somerville, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7615467","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_optional","internal_job_id":3362291,"location":{"name":"Somerville, Massachusetts"},"metadata":null,"id":7615467,"updated_at":"2026-05-15T08:52:52-04:00","requisition_id":"4438","title":"Head of Product/Portfolio Management ","company_name":"Genetix Biotherapeutics","first_published":"2026-02-13T12:38:04-05:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;SUMMARY\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The \u0026lt;span data-olk-copy-source=\u0026quot;MessageBody\u0026quot;\u0026gt;Head of Product/Portfolio Management \u0026lt;/span\u0026gt;\u0026amp;nbsp;is a strategic leader for Genetix’ two FDA approved genetic therapies for the treatment of hemoglobinopathies. You will be responsible for establishing the long-term product strategy while enabling teams to achieve execution of lifecycle management plans. You will provide cross-functional leadership across drug development and lifecycle management execution to maximize long-term value for two commercial stage products. You will drive achievement of product goals and advancing Genetix’s leadership in transforming lives through curative therapies. The ideal candidate will be a strategic leader well-versed in drug development and commercial execution and a strong influencer who can integrate effectively while aligning stakeholders across different functions and levels of the organization. Reporting to the Chief of Staff \u0026amp;amp; Head of Corporate Development and Strategy, you will champion critical portions of Genetix’s leading assets with significant executive visibility and potential for patient impact.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;RESPONSIBILITIES\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead the cross-functional team consisting of senior leaders in Commercial, CMC, Regulatory, Medical, and Clinical, responsible for setting and achieving product vision and strategy\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Incorporate the long-term vision to develop, optimize, and execute lifecycle management plans\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive the development and execution of the integrated cross-functional strategic and operational product plan and timelines\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Integrate cross-functional perspectives, ensuring technical rigor, emerging data, competition, and the evolving landscape in key markets are incorporated routinely to inform product direction\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with functional leads and senior leadership to set product goals aligned with corporate goals\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Foster strong cross-functional team performance, empowering the team while driving alignment, accountability, prioritization, and timely decision making to deliver on product goals\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proactively anticipate issues and ensure contingency plans are put in place; identify barriers and problem-solve to mitigate them; identify opportunities and how to capture them\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Establish clear product communications and deliver critical updates between teams and senior leaders, ensuring strategic alignment and awareness of changes to strategy or timelines\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with corporate communications and the Executive Team to develop product communication strategies, positioning, and messaging\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive innovation and maximize long-term value creation by challenging the status quo\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;QUALIFICATIONS\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;10+ years of industry experience with 5+ years leading drug development programs/products or in life sciences consulting\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;BA/BS degree required, advanced degree preferred (MBA, PharmD, PhD, MD)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Deep understanding of drug development \u0026amp;amp; commercialization\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Cell and gene therapy, rare disease, and hemoglobinopathy experience strongly preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Fully and consistently demonstrates strong communication skills across all levels and functions – able to succinctly summarize complex issues (verbally and in writing) to move team forward\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;An authentic leader who builds and maintains strong relationships and trust, with exceptional ability to influence key stakeholders at all levels in a matrix environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to inspire, empower and motivate teams without direct authority to cultivate high performance by creating an environment that invites diverse perspectives, continual improvement, and opportunistic thinking\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A strong collaborator who communicates in an open, direct, and timely manner\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Flexibility and the ability to nimbly adapt to changing conditions\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Motivated by patient focus and personal commitment to high performance and results\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Possesses high integrity and exceptional work ethic\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong experience with program management best practices\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Advanced PowerPoint efficiency\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$263,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$323,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":346672,"name":"Business Operations","child_ids":[],"parent_id":346671}],"offices":[{"id":86122,"name":"Somerville","location":"Somerville, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7701282","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":3384848,"location":{"name":"Somerville, MA"},"metadata":null,"id":7701282,"updated_at":"2026-05-12T13:18:53-04:00","requisition_id":"4449","title":"Manager, Cost Accounting","company_name":"Genetix Biotherapeutics","first_published":"2026-03-10T15:08:45-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;SUMMARY\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Manager of Cost Accounting will own the accounting for the Company’s inventory and cost accounting, to ensure accurate, efficient reporting of the Company’s Cost of Goods Sold and related accounts. The role will work closely with the Accounting and Reporting team, operational accounting and FP\u0026amp;amp;A team, as well as with Procurement, Supply Chain and Manufacturing. You will also be responsible for ensuring and supporting the most efficient implementation of a systematic cost accounting module within NetSuite.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;RESPONSIBILITIES\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Accounting for and supporting the operational aspects for the Inventory cycle including COGs, Bill of Materials (BOM’s), inventory management \u0026amp;amp; reconciliations, variance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Responsibility for all aspects of the implementation of the inventory and COGS modules of NetSuite\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Managing and improving cost accounting models\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Managing the monthly, quarterly, and annual financial close process for costing and inventory module, to ensure accuracy of transactions, journal entries, account\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Generating accurate and timely inventory and costing reports to support continuous improvement initiatives.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborating with the finance team when preparing financial analysis of manufacturing variances, gross margin, and excess and obsolete inventory.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Reviewing standard costs quarterly\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Successfully partnering with FP\u0026amp;amp;A, technical accounting and the functional business owners in the annual budgeting and quarterly forecasting of manufacturing costs, monthly close and reporting of actual cost versus the budget and the most recent forecast and preparation of and explanation for key performance indicators.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Driving and supporting internal manufacturing finance controls and processes with a continuous improvement methodology.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Interacting with internal and external auditors, providing various analysis and audit schedules to ensure compliance with internal control procedures\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Other related tasks as needed\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;QUALIFICATIONS\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;7+ years of experience in cost accounting, with at least a Bachelor’s degree in\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Certification in Cost Accounting preferred but not\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience in cost accounting for the biotech / pharmaceutical manufacturing industries that has both internal and external manufacturing and testing costs.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience building and leading a\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Are familiar with NetSuite.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent business partnership and team development\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Results-orientation with the proven ability to execute on collaborative projects and develop subject matter expertise.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$121,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$161,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":33610,"name":"General \u0026 Admin","child_ids":[33593,33590,33596,294469],"parent_id":null}],"offices":[{"id":86122,"name":"Somerville","location":"Somerville, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7960510","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":3456304,"location":{"name":"Somerville, MA"},"metadata":null,"id":7960510,"updated_at":"2026-06-12T14:11:09-04:00","requisition_id":"4487","title":"Manager, QA Operations Disposition","company_name":"Genetix Biotherapeutics","first_published":"2026-05-27T11:00:57-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;SUMMARY\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Manager, QA Operations Disposition role supports the release of externally manufactured drug products, viral vector materials, and qualified starting materials used in Genetix Cell \u0026amp;amp; Gene therapy (CGT) programs. This role ensures that incoming documentation packages meet internal quality standards and regulatory expectations while enabling timely product availability. The position plays a key role in maintaining compliant supply flow from external manufacturing partners and material vendors. The individual works cross-functionally with Quality, External Manufacturing, Supply Chain, and Technical Operations to ensure right-first-time disposition activities.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;RESPONSIBILITIES\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Perform quality review of executed batch records, CoAs, CoCs, deviation summaries, and supporting documentation for external drug product and viral vector manufacturing, ensuring compliance with cGMP and internal procedures.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Support timely disposition of vendor‑provided starting materials by reviewing supplier documentation, qualification records, and material release files.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Partner with External Manufacturing, MSAT, and Supply Chain to track batch status and document readiness, escalating issues to ensure on‑time release.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Document observations, data gaps, and quality concerns; coordinate with internal teams and external partners to drive resolution.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Maintain accurate records within electronic quality systems, including document management, deviations, and change control workflows.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Support continuous improvement initiatives aimed at strengthening lot disposition processes and external collaboration models.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Assist with preparation for audits and inspections by ensuring disposition documentation is complete, accurate, and inspection‑ready.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Support internal and external audits by preparing, organizing, and providing lot disposition documentation, including batch records, CoAs/CoCs, deviation summaries, and supporting evidence.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Assist in developing and implementing corrective and preventive actions (CAPAs) arising from audit observations related to lot disposition or external manufacturing documentation.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Support User Acceptance Testing and implementation of a digitalized CGT lot disposition process\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Proactively identify and drive operational excellence opportunities within the lot disposition process to enhance efficiency, reduce cycle time, and strengthen compliance.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;QUALIFICATIONS\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Bachelor’s degree in a STEM field (Biology, Biotechnology, Chemistry, Engineering, or related discipline).\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- 7+ years of experience in a regulated biopharmaceutical, biologics, or gene therapy manufacturing environment, with direct exposure to cGMP quality systems.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Demonstrated experience performing lot disposition, batch record review, or quality review activities for externally manufactured materials or products.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Experience collaborating with CMOs/CDMOs, including navigating external partner quality systems, document flows, and communication pathways.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Strong understanding of GMP documentation standards, including batch records, CoAs/CoCs, deviation investigations, and technical reports.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Proficiency with electronic systems such as eQMS, document management systems, LIMS, and/or batch record management platforms.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Ability to interpret and apply regulatory expectations from FDA, EMA, and ICH relevant to biologics, aseptic operations, and advanced therapy medicinal products (ATMPs).\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Excellent organizational, analytical, and communication skills, with ability to independently prioritize across multiple concurrent batches and partner sites.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;- Demonstrated ability to drive completion of documentation, investigations, and audits in collaboration with cross‑functional and external teams.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$118,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$166,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":33671,"name":"Quality Assurance","child_ids":[],"parent_id":33598}],"offices":[{"id":86122,"name":"Somerville","location":"Somerville, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7964131","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":3457675,"location":{"name":"Somerville, MA"},"metadata":null,"id":7964131,"updated_at":"2026-05-28T16:27:12-04:00","requisition_id":"4489","title":"Manager, Quality Assurance Operations","company_name":"Genetix Biotherapeutics","first_published":"2026-05-28T14:54:16-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Summary\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The ‘Manager, Quality Assurance Operations’ role is responsible for providing end-to-end quality oversight of Contract Manufacturing Organizations (CMOs) to ensure compliance with cGMP regulations, regulatory commitments, and Genetix quality standards. This role serves as a key quality partner to Manufacturing, MS\u0026amp;amp;T, Quality Control, and Patient Supply. The role is expected to serve as a CMO Lead point-of-contact and primary quality interface with external partners, driving proactive risk management, and Deviation and Change Control lifecycle management. The position ensures effective quality oversight through structured governance forums, review and approval of quality systems, and continuous monitoring of performance metrics.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Responsibilities\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• Provide on-call QA support for manufacturing operations, ensuring proactive identification, escalation, and mitigation of quality events and risks impacting ongoing manufacturing and product disposition\u0026lt;br\u0026gt;• Maintain a consistent and effective external oversight model, including leading QA-to-QA forums and guiding quality discussions in joint governance meetings with CMOs.\u0026lt;br\u0026gt;• Lead regular internal Deviation/Lab Investigation Management meetings, ensuring compliance, quality, and timeliness.\u0026lt;br\u0026gt;• Review and Approve internal and external CMO Deviations and Change Controls\u0026lt;br\u0026gt;• Serve as QA point-of-contact for Product Complaints, ensuring appropriate investigation, documentation, and closure.\u0026lt;br\u0026gt;• Perform Quality Impact Assessments for Change Controls, ensuring appropriate risk evaluation and mitigation.\u0026lt;br\u0026gt;• Represent Quality Assurance Operations in Manufacturing Tier meetings, ensuring alignment on quality risks, priorities, and escalation pathways.\u0026lt;br\u0026gt;• Represent Quality Assurance Operations in Change Control Review Board (CCRB) meetings.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;• Serve as QA reviewer and approver for: process validation protocols and reports, technical reports and supporting documentation, and internal and external validation deliverables\u0026lt;br\u0026gt;• Monitor CMO quality performance metrics, identify trends, and drive continuous improvement initiatives.\u0026lt;br\u0026gt;• Own and manage CMO Quality Agreements, including authoring, reviewing, negotiating, and maintaining compliance with current regulatory expectations.\u0026lt;br\u0026gt;• Author and review Annual Product Quality Reviews (APQRs) to ensure comprehensive evaluation of product and process performance.\u0026lt;br\u0026gt;• Identify trends, risks, and opportunities for improvement across the product lifecycle.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required Education, Experience, or Qualifications (or equivalent)\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;Education \u0026amp;amp; Experience\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• Bachelor’s degree in Life Sciences, Engineering, or related discipline (advanced degree preferred)\u0026lt;br\u0026gt;• 7+ years of experience in Quality Assurance within GMP-regulated biopharmaceutical or cell/gene therapy manufacturing\u0026lt;br\u0026gt;• Strong experience supporting CMO oversight and external manufacturing environments\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;Technical Skills\u0026lt;/span\u0026gt;\u0026lt;br\u0026gt;• Deep knowledge of: cGMP regulations (FDA, EMA, ICH guidelines), Deviation, CAPA, and investigation processes, Change Control systems and validation lifecycle\u0026lt;br\u0026gt;• Knowledge of lentiviral vector process preferred\u0026lt;br\u0026gt;• Knowledge of process validation preferred\u0026lt;br\u0026gt;• Strong understanding of cell/gene therapy manufacturing or biologics\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;span style=\u0026quot;text-decoration: underline;\u0026quot;\u0026gt;Leadership \u0026amp;amp; Competencies\u0026lt;/span\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated ability to lead cross-functional quality governance forums\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong risk-based decision-making and escalation capabilities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent communication, stakeholder management, and influential skills in internal and external settings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to operate effectively in a fast-paced, matrixed CMO environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;High attention to detail with an inspection-ready mindset\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;br\u0026gt;\u0026lt;strong\u0026gt;Key Success Factors\u0026lt;/strong\u0026gt;\u0026lt;br\u0026gt;• Proactive risk identification and escalation during manufacturing operations\u0026lt;br\u0026gt;• Timely closure and high-quality management of deviations and investigations\u0026lt;br\u0026gt;• Strong, compliant oversight of CMO operations and quality systems\u0026lt;br\u0026gt;• Effective cross-functional collaboration and governance leadership\u0026lt;br\u0026gt;• Continuous improvement of quality systems and performance metrics\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$118,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$166,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":33671,"name":"Quality Assurance","child_ids":[],"parent_id":33598}],"offices":[{"id":86122,"name":"Somerville","location":"Somerville, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7745912","data_compliance":[{"type":"gdpr","requires_consent":false,"requires_processing_consent":false,"requires_retention_consent":false,"retention_period":null,"demographic_data_consent_applies":false}],"education":"education_required","internal_job_id":3396835,"location":{"name":"Remote, US / Field Based"},"metadata":null,"id":7745912,"updated_at":"2026-05-22T12:14:46-04:00","requisition_id":"4463","title":"National Account Executive - Southeast","company_name":"Genetix Biotherapeutics","first_published":"2026-03-24T09:57:18-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;SUMMARY\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix Biotherapeutics\u0026#39; Market Access, Advocacy + Policy (MAAP) team is dedicated to helping patients access our innovative gene therapies.\u0026amp;nbsp; We\u0026#39;re seeking a mission-driven \u0026lt;strong\u0026gt;National Account Executive\u0026lt;/strong\u0026gt; to implement the strategic direction and execution of all payer engagements and access initiatives to ensure timely and sustained reimbursement for the company’s gene therapy portfolio. The National Account Executive is responsible for engaging commercial and government payers, executing innovative value-based agreements, and partnering with treatment centers to streamline access pathways. The ideal candidate brings deep expertise in payer strategy and engagement, contracting, treatment center collaboration, and leadership within specialty or gene therapy markets, coupled with a passion for ensuring patients can access transformative, one-time treatments.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;As a member of the Market Access Advocacy and Policy team (MAAP) you will be working alongside some of the most committed, creative, and experienced individuals in the cell and gene therapy industry to break new ground so that patients can access our FDA-approved gene therapies, patients who often have no therapeutic alternatives to battle progressive, debilitating, and life-shortening diseases. We are passionate about the science behind our gene therapies and the tremendous value we believe these one-time administered, potentially curative therapies bring to patients, their families, the healthcare system, and society overall. Everyone on our team has external-facing responsibilities, so we aim to be integrated and data- and evidence-driven to capitalize on the dynamic flow of information and insights across stakeholders (always being sure to maintain the highest standards of compliance). Join us if you work best in a fast-paced and highly collaborative environment!\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;*THIS IS A FIELD BASED POSITION AND WILL COVER THE SOUTHEAST REGION: Florida, Georgia, Louisiana, Arkansas, Mississippi, Alabama\u0026lt;/p\u0026gt;\n\u0026lt;div id=\u0026quot;focus_scorecard_attributes\u0026quot; class=\u0026quot;content-box content-box-alt\u0026quot;\u0026gt;\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;RESPONSIBILITIES\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Meet access goals and ensure medical coverage pathways are consistent with FDA approved prescribing information\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with Qualified Treatment Center (QTC) Account Liaisons, Marketing, Patient Support Team and Medical Value Liaisons and other Genetix stakeholders to identify access barriers and ensure patient access\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Implement strategies and tactics to support individual patient access and reimbursement (e.g., coverage, coding) across payer segments\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as the primary, regional point-of-contact for Genetix’s Qualified Treatment Center network for all market access-related issues.\u0026amp;nbsp; Proactively educate QTC around state Medicaid and commercial payer coverage criteria, PA process and requirements as well as addressing account specific educational gaps in our treatment process and pathway.\u0026amp;nbsp; Create confidence in the access pathway for our therapies by leveraging published medical policies and patient approvals across the QTC network and aligning all messaging to our market access engagement strategy\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and maintain core relationships with the business functions at Genetix’s QTCs with a focus on patient pull through, including but not limited to, managed care contracting, CFO and revenue cycle, government affairs, billing department leads, along with hospital quality and legal teams, gene therapy coordinators, financial coordinators and PA and appeals support\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proactively work in a preventative measure with QTCs to establish hygienic PA submissions to alleviate incomplete submissions or administrative inaccuracies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Consistently engage National and Regional commercial payers, FFS and Managed Medicaid plans, and Federal payers to positively influence decision makers in areas of clinical criteria and medical policy.\u0026amp;nbsp; Present, negotiate and execute Value Based Agreements (VBA) at the payer level to facilitate timely access to FDA-approved Genetix therapies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Negotiate and manage value contracts with assigned payers for optimal Genetix product access\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Respond to ad hoc requests by small regional payers in assigned territory\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Work within the payer ecosystem to identify delays or friction in the approval process, develop a plan, and implement a timely resolution.\u0026amp;nbsp; Provide support and pull through strategies to the QTCs when to overcome delays within the process ex: PA requirements and any PA denials, distribution channel preference etc.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Educate QTCs with Letter of Intent on considerations for case rate agreements to reduce delays.\u0026amp;nbsp; Connect QTCs with other QTCs for best practice sharing or connect them with appropriate decision makers at the health plan for issue escalation and resolution.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Identify and leverage contacts within the payers and connect those payer stakeholders with the QTC to streamline PA review and approval processes\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Work cross-functionally within the POD team structure to ensure alignment across Genetix’s stakeholders and that QTCs receive surround sound support at every step in the patient journey; these cross functional partners include: apheresis, patient support, field medical, legal and contracting, and working closely with the QTC account leads to mitigate and/or remove barriers to care at the consult and treatment phases of the patient journey.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Work closely with Medical Value Liaison (MVL) in tandem for targeted situations e.g. PA prep, appeals, policy and coverage influence\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Share insights and feedback from across market access stakeholders (with a focus on payers and financial decision makers at QTCs)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Encourage and facilitate QTC patient’s enrollment into Genetix’s patient support program\u0026amp;nbsp;to enrich the patient treatment journey\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain the utmost standard of professionalism and compliance in all internal and external engagements\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;QUALIFICATIONS\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;10 years of experience in the biotech/pharma field with a bachelor’s degree required; master’s degree in a relevant health or finance related field preferred\u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A track record of success engaging tertiary and quaternary clinical and research institutions and integrated delivery networks on market access issues \u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Comprehensive understanding of the current and evolving US payer landscape within cell and gene therapies or complex therapies from a both medical and pharmacy benefit perspective\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong clinical aptitude/acumen\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Deep knowledge of U.S. markets and understanding of Commercial Payers, PBMs, Stop Loss and Reinsurance and Government Payers (FFS and Managed Medicaid, Medicare, and TRICARE)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Established relationships with Pharmacy Directors, Medical Directors, and other key stakeholders with assigned accounts\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated knowledge and specialty pharmacy and buy and bill procurement models across commercial and government payers; recent experience preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated expertise as a subject matter expert (SME) for assigned key payer accounts with experience in navigating complex vertically integrated orgs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience negotiating and implementing outcomes-based or other alternative payment models preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Exceptional customer business planning, tactical planning, and successful execution skills\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;High degree of attention to detail including proven ability to manage multiple, competing priorities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026lt;strong\u0026gt;Travel 50%\u0026lt;/strong\u0026gt;\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;div class=\u0026quot;ewa-rteLine\u0026quot;\u0026gt;\u0026lt;strong\u0026gt;Additional Information:\u0026lt;/strong\u0026gt;\u0026lt;/div\u0026gt;\n\u0026lt;div class=\u0026quot;ewa-rteLine\u0026quot;\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter shutdown, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, generous commuter subsidy, and much more.\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$204,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$271,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":70252,"name":"Field Based Teams (AVES)","child_ids":[],"parent_id":33678}],"offices":[{"id":266558,"name":"Field-based","location":"Field","child_ids":[],"parent_id":null},{"id":22344,"name":"US Remote","location":null,"child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7974214","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":3461097,"location":{"name":"Somerville, MA"},"metadata":null,"id":7974214,"updated_at":"2026-06-01T13:08:21-04:00","requisition_id":"4490","title":"Payroll and T\u0026E Specialist","company_name":"Genetix Biotherapeutics","first_published":"2026-06-01T13:08:21-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;SUMMARY\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;We are seeking a detail-oriented and dependable Payroll and T\u0026amp;amp;E Specialist to support the accurate and timely processing of multi-state payroll and employee expense reimbursements. This individual contributor role is responsible for payroll and employee expense administration, employee payroll support, compliance monitoring, and maintaining payroll records while partnering closely with HR and Finance teams. The ideal candidate will have hands-on experience with ADP payroll platforms, SAP Concur spend management software, strong analytical skills, and the ability to manage payroll and T\u0026amp;amp;E activities in a fast-paced environment with a high degree of accuracy and confidentiality.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;RESPONSIBILITIE\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;S \u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Process biweekly and/or semi-monthly payroll accurately and on schedule using ADP payroll systems\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review employee expense reports for compliance with policy and process reimbursements using Concur.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Review and audit payroll data including timecards, earnings, deductions, taxes, and benefit withholdings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain employee payroll records and ensure compliance with federal, state, and local payroll regulations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Process new hires, terminations, compensation changes, garnishments, bonuses, and off-cycle payrolls\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Respond to employee inquiries related to payroll, taxes, direct deposit, and deductions in a professional and timely manner\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Reconcile payroll reports and assist with month-end, quarter-end, and year-end payroll activities including W-2 processing\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with HR and Finance to ensure accurate employee data and payroll reporting\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assist with payroll audits and support compliance documentation requests\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;QUALIFICATIONS \u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;3+ years of payroll and expense report processing experience\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Hands-on experience with ADP Workforce Now, NetSuite and SAP Concur, strongly preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience processing multi-state payroll\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Working knowledge of payroll tax regulations, wage and hour laws, and payroll best practices\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficiency in Microsoft Office suite, particularly Excel, required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to prioritize tasks, meet deadlines, and work independently\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;High level of discretion and professionalism when handling confidential information\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$88,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$120,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":33590,"name":"Finance","child_ids":[],"parent_id":33610}],"offices":[{"id":86122,"name":"Somerville","location":"Somerville, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7773646","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":3403863,"location":{"name":"Somerville, Massachusetts, United States"},"metadata":null,"id":7773646,"updated_at":"2026-04-29T12:03:57-04:00","requisition_id":"4472","title":"QA Manager, Qualified Treatment Center Oversight","company_name":"Genetix Biotherapeutics","first_published":"2026-04-01T15:16:54-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;SUMMARY\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Quality Assurance Manager, Qualified Treatment Centers will provide QA oversight for onboarding and routine operations at QTCs supporting Genetix’s commercial gene therapies. Additionally, the incumbent in this highly visible role will support building scalable QA processes as Genetix continues to grow, creating energized, efficient, and effective teams internally collaborating with Apheresis Operations, Global Supply Chain (Patient Supply) and Quality Compliance. Day to day responsibilities include establishing and maintaining Quality Agreements with QTCs, primary QA oversight of change controls managing QTC onboarding, QA approval and resolution of QTC-related quality documentation. In addition, support for quality system record management related to collecting and transporting apheresis products and the quality oversight of QTC use of Genetix traceability systems.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;RESPONSIBILITIE\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;S \u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Ensuring compliance with quality expectations and industry guidelines in the areas of Good Tissue Practices (GTP), Good Manufacturing Practice (GMP) and Good Documentation Practice (GDocP) for apheresis products and Genetix QTCs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Building relationships with QA partners at QTCs, ensuring quality issues are tracked and resolved in a timely manner and working across the internal Genetix functional network in providing quality oversight of our QTC external partnerships\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensuring an appropriate, consistent, and harmonized quality approach is standard across all QTCs through Quality Agreement initiation, review, execution, and maintenance\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Tracking and trending quality system event generation at QTCs, providing periodic updates to management\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Reviewing and approving documents including apheresis collection records, policies and procedures, deviations, investigations, and partner CAPA action plans\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Reviewing and approving internal deviations, CAPA, and Change Control, performing Failure Mode and Effect Analyses, root cause analyses, and CAPA effectiveness check as required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Developing, monitoring and improving Quality processes which are scalable and sustainable to meet the organization’s growing needs while supporting the development, implementation, and revision of corporate quality systems\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assisting with internal and external Quality Audits\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Fostering a Quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions)\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;QUALIFICATIONS\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;BS/BA and a minimum of 7+ years working experience in cell therapy (or applicable) environment. Experience in a hospital setting preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge of FACT accreditation requirements and their application for collection of apheresis and/or cell therapy lab preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong knowledge of GTP regulations and guidance documents\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience with quality agreements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated leadership within cross-functional teams with identifying areas of improvement, then participating in the design and delivery of improvements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Technical understanding of biopharmaceutical production, with experience in cell and gene therapy a plus.\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;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$115,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$140,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":33671,"name":"Quality Assurance","child_ids":[],"parent_id":33598}],"offices":[{"id":86122,"name":"Somerville","location":"Somerville, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7883262","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":3429738,"location":{"name":"Somerville, Massachusetts, United States"},"metadata":null,"id":7883262,"updated_at":"2026-06-01T06:41:37-04:00","requisition_id":"4480","title":"Sr. Director Process Development","company_name":"Genetix Biotherapeutics","first_published":"2026-05-04T09:28:17-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Sr. Director, Process Development\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;This is a hybrid position in our Somerville, Massachusetts office with regular presence in our lab facility.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;SUMMARY\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior Director, Process Development, will provide strategic technical and operational leadership for the Process Development team within Technical Development supporting our company’s gene therapy product portfolio. This role will oversee the design and execution of process development, drive continuous improvement initiatives, advance new unit operations, and technically drive the end-to-end transfer to external manufacturing.\u0026amp;nbsp; The role must partner successfully cross-functionally within Technical Development and across Technical Operations.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The ideal candidate will bring deep expertise in cell and gene therapy (CGT) process development, a track record of successful prior innovations, and the leadership acumen to bridge the gap from the laboratory to routine manufacturing.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;RESPONSIBILITIES\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Strategy\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide strategic oversight and day-to-day management of process development workflows internally and externally.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with Analytical Sciences ensuring alignment with process development milestones and regulatory requirements.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Propose and drive the development of continuous improvements in process, from the smallest detail in execution to an entire unit operation.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Actively participate in establishing the appropriate technical rigor needed to support strategic decisions including appropriate utilization of small-scale models and the scale down model qualification.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Continuous Improvement and Process Optimization\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead a high-performing team of scientists in the design and development of process improvements, leveraging both internal experiments and external vendors.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive high quality execution of rapid optimization cycles and successful comparability studies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive innovation in continuous improvement activities whether through novel unit operation development or designing the ideal custom consumable part that improves manufacturability.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure all new processes are developed with a \u0026quot;right first time\u0026quot; approach to facilitate seamless transition to a GMP environment.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;External\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Acts as the ultimate technical authority for Process Development, starting with first principles and best practices for process development and extending to strategic approach externally.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversight of the design and execution of external process development activities, ensuring development activities are equivalent to internal standards.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Cross-Functional Leadership \u0026amp;amp; Compliance\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Collaborate across CMC to support regulatory submissions and inquiries.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Author and review high-quality technical reports, SOPs, and CMC sections of regulatory filings.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Build and mentor a world-class process development team, fostering individual team member development while in parallel maintaining a culture of scientific rigor and operational excellence.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage resource allocation and timelines to ensure program delivery.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Qualifications\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Education: Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology or a related scientific discipline.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience: 10+ years of progressive experience in the biopharmaceutical industry, with at least 5 years in a people management role specifically within Process Development for Cell and Gene Therapies.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Technical Expertise: Deep hands-on and strategic knowledge of best practices in process development supporting cell therapy manufacturing. Ideal candidate will have prior CD34+ and/or viral vector experience. Understanding of analytical techniques such as flow cytometry, PCR, etc. that are core to cell therapy product quality is required.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Track Record: Proven success in developing and transferring processes to external CDMOs and supporting successful regulatory filings (IND/BLA/MAA) including resolving root cause investigations.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Communication: Exceptional verbal and written communication skills, with the ability to translate complex process development data and decisions into strategic insights for senior leadership.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$267,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$285,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":33669,"name":"Process Development","child_ids":[],"parent_id":33598}],"offices":[{"id":86122,"name":"Somerville","location":"Somerville, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7713770","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":3388263,"location":{"name":"Somerville, MA"},"metadata":null,"id":7713770,"updated_at":"2026-04-29T12:03:57-04:00","requisition_id":"4455","title":"Sr. Director, Regulatory CMC","company_name":"Genetix Biotherapeutics","first_published":"2026-03-12T16:54:35-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;h4\u0026gt;Position Description\u0026lt;/h4\u0026gt;\n\u0026lt;p\u0026gt;The Senior Director, Regulatory CMC is responsible for defining and executing global CMC regulatory strategy for approved and late-stage gene therapy products, with a strong emphasis on lifecycle management, change management, and sustained regulatory compliance. This role provides strategic regulatory leadership across Genetix programs, ensuring efficient implementation of post-approval manufacturing, analytical, and control changes while maintaining product supply and inspection readiness.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior Director serves as a key regulatory partner to Technical Operations, Quality, and Supply Chain, and acts as the primary CMC regulatory interface with global health authorities for post-approval activities, including supplements, variations, annual reports, and inspection support.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong data-olk-copy-source=\u0026quot;MessageBody\u0026quot;\u0026gt;This is a full-time hybrid position (3 days a week) in our Somerville, Massachusetts office.\u0026amp;nbsp;\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;h4\u0026gt;Specific Job Duties\u0026lt;/h4\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Provide strategic leadership for post-approval CMC lifecycle management activities for Genetix gene therapy products, including planning and execution of global supplements, variations, and annual regulatory filings\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Own and drive global CMC change management strategy, assessing manufacturing, analytical, raw material, facility, and control strategy changes and defining optimal and aggressie regulatory pathways for implementation\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness, including responses to health authority questions and commitments\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as the primary regulatory CMC lead for post-approval health authority interactions, including Type C/Scientific Advice meetings, responses to information requests, and support of GMP inspections\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner closely with Pharmaceutical Sciences, Technical Operations, Quality, Supply Chain, and Program Teams to ensure alignment between regulatory strategy and operational execution\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide regulatory oversight and approval of post-approval CMC documentation, ensuring consistency with approved dossiers and global regulatory requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive adherence to global CMC regulatory standards and guidance (FDA, EMA, ICH) applicable to commercial and post-approval gene therapy products\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Contribute to and lead regulatory intelligence efforts related to post-approval expectations, emerging guidance, and evolving inspection trends impacting gene therapy products\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Mentor and develop Regulatory CMC team members, building scalable post-approval regulatory capabilities to support Genetix portfolio growth\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Represent Regulatory CMC on cross-functional governance forums, providing clear, risk-based regulatory recommendations\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;h4\u0026gt;Required Education, Experience, or Qualifications\u0026lt;/h4\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s or Master’s degree in life sciences (biochemistry, chemistry, biology, biochemical engineering, or related field); PhD preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Minimum of 15 years of biopharmaceutical industry experience, with significant experience in post-approval CMC regulatory affairs for cell and gene therapies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience leading post-approval submissions, including supplements, variations, and annual reports, and supporting health authority GMP inspections\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong working knowledge of commercial manufacturing and lifecycle management for complex biologics and gene therapy products\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent written and verbal communication skills with proven ability to translate complex technical issues into clear regulatory strategies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven leadership skills, including strategic thinking, people development, cross-functional influence, and decision-making in a matrix environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Deep understanding of GMP, CMC regulatory requirements, and global regulatory frameworks (FDA, EMA, ICH)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Highly organized, detail-oriented, and solution-focused, with the ability to manage multiple priorities and drive execution to completion\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$156,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$316,500 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":33602,"name":"Regulatory","child_ids":[],"parent_id":33664}],"offices":[{"id":86122,"name":"Somerville","location":"Somerville, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7814964","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":3412556,"location":{"name":"Somerville, MA"},"metadata":null,"id":7814964,"updated_at":"2026-04-29T12:03:57-04:00","requisition_id":"4476","title":"Sr. Manager, CMC Project Management","company_name":"Genetix Biotherapeutics","first_published":"2026-04-14T10:10:21-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;The CMC Project Manager is responsible for driving cross‑functional execution of Commercial CMC programs for approved cell and gene therapy products. This role partners closely with CMC functional leaders and teams to ensure disciplined planning, risk management, and delivery of post‑approval commitments that support uninterrupted commercial supply.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;A primary focus of the role will be leading a CMC sub‑team, including coordination with an external partners, to deliver a critical commercial milestones. This position operates in a highly matrixed environment and requires strong project leadership, clear communication, and the ability to manage complex interdependencies across CMC functions.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;This role is a full time hybrid position (3 days a week in the office) located in our Somerville, Massachusetts office.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;RESPONSIBILITIES\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Lead Commercial CMC teams and drive execution of CMC activities aligned with program, regulatory, and supply objectives\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop, maintain, and actively manage integrated CMC project plans, including timelines, dependencies, critical path activities, and decision points\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Establish and maintain a CMC risk registry; proactively identify risks, define mitigation strategies, and escalate issues to prevent program delays\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Lead cross‑functional coordination across Manufacturing, Quality, Analytical Development, Regulatory CMC, Supply Chain, and external partners to resolve complex CMC issues\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage CMC execution in collaboration with key external partners, ensuring accountability to scope, timeline, and deliverables for key commercial milestones\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prepare and deliver concise, data‑driven updates to senior leadership and governance forums on CMC status, risks, and execution options\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Co‑lead CMC team meetings and governance forums, applying strong meeting management practices to enable timely decision‑making and follow‑through\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Promote a culture of ownership, accountability, and continuous improvement across CMC project teams\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;QUALIFICATIONS\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s, Master’s, or Ph.D. in life sciences or a related discipline, or equivalent industry experience\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Minimum of 6 years of biopharmaceutical industry experience; experience supporting late‑stage or commercial programs strongly preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;At least 2 years of project management experience or demonstrated success leading cross‑functional teams in a fast‑paced biotech or pharmaceutical environment\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proven ability to manage complex, cross‑functional programs, identify and mitigate risk, and drive execution in a matrixed organization\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong working knowledge of CMC development, manufacturing, and quality concepts; cell and gene therapy experience is a strong plus\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficiency with project management and collaboration tools, including Microsoft Project, PowerPoint, Excel, and OneNote\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong organizational skills with the ability to manage multiple priorities and shifting timelines\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated ability to translate complex technical plans into clear, actionable communication for technical and non‑technical stakeholders\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$136,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$179,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":70241,"name":"Drug Product Manufacturing","child_ids":[],"parent_id":33598}],"offices":[{"id":86122,"name":"Somerville","location":"Somerville, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7814860","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":3412515,"location":{"name":"Somerville, Massachusetts"},"metadata":null,"id":7814860,"updated_at":"2026-05-20T08:58:30-04:00","requisition_id":"4475","title":"Sr. Manager, Insights, Analytics, and Market Research ","company_name":"Genetix Biotherapeutics","first_published":"2026-05-15T13:11:44-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;SUMMARY\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior Manager, Insights, Analytics, and Market Research will be a key architect of Genetix’s commercial intelligence capabilities. You will build the company’s centralized market research function, drive commercial forecasting and KPI management, and translate data into insights that sharpen strategy and drive proactive decision-making across the commercial organization. This role spans primary research, predictive modeling, KPI tracking, and competitive intelligence — and requires someone who is equally comfortable in a spreadsheet and a boardroom. This is an opportunity to have outsized impact at a lean, mission-driven company where your work directly shapes how we reach and serve patients with life-altering rare diseases.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;This is a Hybrid position (3 days a week) based in our Somerville – Assembly Row, Massachusetts office\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;RESPONSIBILITIES\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;em\u0026gt;Analytics, Forecasting \u0026amp;amp; Commercial Strategy – data-driven decision making\u0026lt;/em\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Partner with functions across the commercial organization to establish and scale analytics capabilities that enable proactive, evidence-based decision-making\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive long-term demand and commercial forecasting for our portfolio, building and maintaining models that support strategic planning, resource allocation, and financial decision-making; track actuals against forecast and communicate variances and implications to company leadership\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop predictive models that incorporate market dynamics and upstream KPIs to identify company risks and opportunities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and maintain dashboards, reports, and KPI frameworks to track brand performance, market dynamics, and the competitive landscape\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Synthesize data and insights into clear, compelling narratives and contribute meaningfully to brand planning, opportunity assessments, and commercial strategy.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Work cross-functionally to support company business development initiatives\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;\u0026lt;em\u0026gt;Market Research – build Genetix’s centralized market research function\u0026lt;/em\u0026gt;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Design and execute primary research — qualitative and quantitative — to capture HCP and patient perspectives on our gene therapies, the treatment experience, and the competitive landscape.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Maintain a continuous pulse on how prescribers, patients, and caregivers think about our therapies relative to standard of care and emerging alternatives based on field insights\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Manage research vendors and agencies, ensuring high-quality deliverables\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;KEY COMPETENCIES\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Creative, solutions-oriented thinker who challenges conventional approaches and explores new tools and methods\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;High ownership and bias toward action\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong analytical and quantitative acumen; able to build rigorous models and distill complexity into clear strategic direction\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent communication and storytelling skills; translates data and models into crisp, persuasive narratives for senior audiences\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaborative, low-ego style with the ability to influence cross-functionally\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Genuine empathy for patients living with rare diseases and the clinicians and caregivers who support them\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;QUALIFICATIONS\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Required:\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelor’s degree required\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;3-10 years of experience in life sciences insight generation \u0026amp;amp; analytics (life sciences consulting, \u0026lt;span data-olk-copy-source=\u0026quot;MessageBody\u0026quot;\u0026gt;healthcare investing\u0026lt;/span\u0026gt;, healthcare equity research, or an analytically rigorous role at a commercial-stage pharma or biotech company); experience in rare disease, hematology, or gene/cell therapy preferred (not required)\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience building or contributing to commercial forecasting models, demand models, or quantitative business analyses\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Proficiency in advanced Microsoft Excel capabilities and leveraging AI tools (e.g., Claude, Microsoft Copilot) to analyze data and generate insights\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience designing or managing primary market research (qualitative and/or quantitative).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong quantitative skills; familiarity with secondary data sources (e.g., IQVIA, Symphony Health) preferred\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent written and verbal communication skills with the ability to present to senior stakeholders clearly and concisely\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":346669,"name":"Patient Advocacy","child_ids":[],"parent_id":33678}],"offices":[{"id":86122,"name":"Somerville","location":"Somerville, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7953750","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":3452493,"location":{"name":"Somerville, MA"},"metadata":null,"id":7953750,"updated_at":"2026-05-22T08:29:01-04:00","requisition_id":"4485","title":"Sr. Manager, Quality CSV","company_name":"Genetix Biotherapeutics","first_published":"2026-05-22T08:29:01-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;SUMMARY \u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The Senior Manager, QA Computer System Validation (CSV) is responsible for\u0026amp;nbsp;QA\u0026amp;nbsp;oversight of\u0026amp;nbsp;the validation and compliance of\u0026amp;nbsp;GxP-regulated computerized systems ensuring they are implemented, maintained, and retired in accordance with global regulatory requirements, industry standards, and internal procedures.\u0026amp;nbsp;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;RESPONSIBILITIE\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;S \u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with IT to ensure internal CSV processes and procedures are aligned to GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9 (risk management), ICH Q10 (PQS), and FDA’s Computer Software Assurance (CSA) guidance.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide QA oversight for new system implementations, upgrades, integrations, cloud/SaaS solutions, and decommissioning activities.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Approve validation deliverables (validation/assurance planning, testing strategy, traceability, UAT, periodic review, and retirement/archival plan, risk assessments, protocols, reports).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure validated systems remain in a controlled state through change management, periodic review, deviation management, and CAPA.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Drive the shift from documentation‑heavy CSV to risk‑focused CSA, maximizing testing on features that impact patient safety, product quality, and data integrity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Own the company’s Data Integrity program for computerized systems (e.g., ALCOA+, audit trails, access controls/segregation of duties, e‑signatures, backup/restore, business continuity/disaster recovery, data retention and archival).\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as QA reviewer/approver of deviations, CAPAs, change controls and effectiveness checks.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support internal/external audits and inspections.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;QUALIFICATIONS\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Bachelors’ and/or master’s degree in computer systems, engineering or related field required.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;A minimum of 7 years of experience in the industry with 5 years of direct CSV experience in GxP environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Thorough knowledge and experience with change control process.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Prior involvement in regulatory inspections with strong inspection-readiness skills.\u0026amp;nbsp;\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Strong analytical and critical thinking skills.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ability to work independently and handle multiple projects in a fast-paced environment.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;High attention to detail and commitment to data integrity.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Collaboration and relationship-building across functional areas.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Hands-on experience with Veeva Vaults preferred.\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$170,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$180,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":33671,"name":"Quality Assurance","child_ids":[],"parent_id":33598}],"offices":[{"id":86122,"name":"Somerville","location":"Somerville, Massachusetts, United States","child_ids":[],"parent_id":null}]},{"absolute_url":"https://job-boards.greenhouse.io/genetixbiotherapeutics/jobs/7768823","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":3402442,"location":{"name":"Somerville, Massachusetts"},"metadata":null,"id":7768823,"updated_at":"2026-04-29T12:03:57-04:00","requisition_id":"4468","title":"Sr. Manager, R\u0026D Quality","company_name":"Genetix Biotherapeutics","first_published":"2026-03-31T12:07:21-04:00","language":"en","application_deadline":null,"content":"\u0026lt;div class=\u0026quot;content-intro\u0026quot;\u0026gt;\u0026lt;div\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContainer\u0026quot;\u0026gt;\n\u0026lt;div data-tid=\u0026quot;messageBodyContent\u0026quot;\u0026gt;\u0026amp;nbsp;\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;/div\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;About Genetix Biotherapeutics\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference. When you join Genetix, you\u0026#39;re not just landing a new role, you become part of a company that\u0026#39;s pursuing curative gene therapies to give patients and their families more days. We are doers, thinkers and collaborators who embrace and live by our values:\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;SUMMARY\u0026amp;nbsp;\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Manage Quality Approval (qualification) of vendors including R\u0026amp;amp;D, GMP and treatment centers (apheresis collection centers and cell therapy labs) by performing qualification audits and routine (requalification) audits.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Oversee R\u0026amp;amp;D compliance for Genetix clinical studies and Support other Quality Compliance functions, which may include but are not limited to:\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Planning and conducting internal audits\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Assisting with inspection readiness efforts\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Supporting GxP inspection readiness and regulatory inspections\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;RESPONSIBILITIE\u0026lt;/strong\u0026gt;\u0026lt;strong\u0026gt;S \u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Collaborate with internal stakeholders (e.g., Apheresis Operations, Commercial, and Clinical Development) and external stakeholders to coordinate and prioritize audits\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Schedule and execute external and internal audits\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure audit observations are communicated, tracked, and remediated in compliance with internal policies and applicable regulatory requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Update approved vendor list, vendor and audit records and develop risk-based audit schedules\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Support annual budget development for outsourced audits\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;\u0026amp;nbsp;Manage Investigator Site Audit Plans for clinical studies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Develop and present vendor metrics at Management Review\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Oversee R\u0026amp;amp;D quality related activities\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as QA contact for QMS records such as external and internal QMS records and lead investigations, deviations, change controls, and CAPAs, especially those involving CGT clinical operations, analytical activities, or site compliance related\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as compliance lead for clinical studies\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure QA supporting documentation is submitted to the TMF, as applicable\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Serve as QA contact for review and approval of Clinical SOPs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Perform Regulatory Document Reviews, as applicable\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Provide quality oversight across CGT clinical studies, ensuring GCP compliance, data integrity, and proper documentation throughout clinical execution\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Ensure clinical trial sites are inspection‑ready and provide quality guidance to external partners, CROs, and CGT clinical facilities, ensuring alignment with internal quality standards and regulatory requirements.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Act as the SME and primary point of contact for inspection management, providing real‑time regulatory guidance.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Partner with Clinical Operations, Regulatory, and Vendor Management teams to identify and mitigate study specific quality risks throughout the trial lifecycle\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;QUALIFICATIONS \u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;8-10 years of experience in gene therapy/cell therapy/biotech/or other related and regulated industry\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;8–10+ years of experience in R\u0026amp;amp;D Quality\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience auditing investigator sites, GMP and R\u0026amp;amp;D vendors and apheresis collection centers and cell therapy labs\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Knowledge of FACT/JACIE requirements\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Demonstrated experience in GCP compliance, clinical trial oversight, inspection readiness, and regulatory interaction\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Direct experience leading clinical deviations, CAPAs, change controls, and investigations\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Experience partnering with Clinical Operations, Regulatory, and cross‑functional stakeholders to manage clinical quality risks\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;p\u0026gt;\u0026amp;nbsp;\u0026lt;strong\u0026gt;Preferred Qualifications\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Experience with CGT‑specific clinical QA such as:\u0026lt;/li\u0026gt;\n\u0026lt;ul\u0026gt;\n\u0026lt;li\u0026gt;Apheresis and cell handling\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Chain‑of‑custody / chain‑of‑identity systems\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\n\u0026lt;li\u0026gt;Strong understanding of CGT‑specific analytical and technical quality processes and technical Quality oversight.\u0026lt;/li\u0026gt;\n\u0026lt;li\u0026gt;Excellent communication and stakeholder influence skills to support global, cross‑functional clinical programs\u0026lt;/li\u0026gt;\n\u0026lt;/ul\u0026gt;\u0026lt;div class=\u0026quot;content-pay-transparency\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;pay-input\u0026quot;\u0026gt;\u0026lt;div class=\u0026quot;description\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Additional Information\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;Genetix’s total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement \u0026amp;amp; loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.\u0026lt;/p\u0026gt;\n\u0026lt;p\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;title\u0026quot;\u0026gt;Pay Transparency\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;pay-range\u0026quot;\u0026gt;\u0026lt;span\u0026gt;$145,000\u0026lt;/span\u0026gt;\u0026lt;span class=\u0026quot;divider\u0026quot;\u0026gt;\u0026amp;mdash;\u0026lt;/span\u0026gt;\u0026lt;span\u0026gt;$195,000 USD\u0026lt;/span\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;/div\u0026gt;\u0026lt;div class=\u0026quot;content-conclusion\u0026quot;\u0026gt;\u0026lt;p\u0026gt;\u0026lt;strong\u0026gt;Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.\u0026amp;nbsp; All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.\u0026lt;/strong\u0026gt;\u0026lt;/p\u0026gt;\u0026lt;/div\u0026gt;","departments":[{"id":33671,"name":"Quality Assurance","child_ids":[],"parent_id":33598}],"offices":[{"id":86122,"name":"Somerville","location":"Somerville, Massachusetts, United States","child_ids":[],"parent_id":null}]}],"meta":{"total":17}}