Position Description

The Director, Regulatory Labeling, Advertising & 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.

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.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

Job Duties and Responsibilities

Core Responsibilities:

Labeling

• Lead the development, negotiation and lifecycle maintenance of global and US product labeling, including pre- and post- approval updates.
• Drive development and maintenance of Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI), ensuring alignment with global regulatory expectations.
• Establish and operationalize labeling strategies that result in clear, concise, compliant and scientifically robust product labels.
• Provide regulatory leadership for labeling-related interactions with Health Authorities, including briefing documents and responses to inquiries.
• Ensure final labeling content meets internal standards and regulatory authority requirements prior to submission or implementation.

Advertising and Promotion

• Oversee regulatory review of US promotional and select non-promotional materials. across channels, ensuring compliance with FDA regulations and enforcement trends
• Serve as the regulatory lead and reviewer for Medical-Legal-Regulatory (MLR) review.
• Partner with Commercial, Medical Affairs and Legal to proactively identify and mitigate regulatory risk in promotional strategy and execution.
• Monitor and interpret FDA enforcement actions and policy developments related to advertising and promotion, translating insights into internal guidance and best practices.
• 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.
• Create and manage promotional submissions documents in the electronic database and partner with Regulatory Operations on submissions.

Governance, Process and Compliance

• Support or co‑lead the Labeling Review Committee (LRC) and provide regulatory oversight of labeling governance processes.
• Develop, maintain, and improve SOPs, workflows, tools, and training related to labeling and Ad/Prom review.
• Ensure inspection readiness and documentation compliance for labeling and promotional activities.
• Drive consistency and operational excellence across labeling and Ad/Prom processes globally.

Cross-Functional Leadership

• Act as a strategic regulatory advisor to Clinical, Safety, Medical Affairs, Commercial, Quality, and Regulatory Strategy teams.
• Lead and mentor internal staff and manage external vendors or consultants as needed.
• Contribute to broader regulatory strategy discussions.

Essential/Required Qualifications:

• Minimum of 10 years of regulatory experience in biotech or pharmaceutical companies.
• Experience supporting FDA interactions related to labeling and promotional compliance
• Experience with MLR review and developing Company Core Data Sheets
• Prior experience in cell and gene therapy or rare disease is strongly preferred.
• Proven ability to lead cross-functional teams and to operate in a matrixed organization, including leadership without direct authority.
• Advanced degree preferred (PharmD, PhD, MD, JD or equivalent degree)
• Excellent written and verbal communication skills.

Preferred Qualifications:

• Prior experience in cell and gene therapy or rare disease is strongly preferred.
• Ability to influence without authority and partner effectively with senior leaders.
• Strong attention to detail and accuracy with sound judgement and risk-based decision making.
• 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.

Key Competencies:

• Deep understanding of FDA regulations and guidance governing labeling and promotional materials.
• An aptitude for problem-solving and ability to quickly understand new science and technology and to resolve issues and conflicts.

Sr. Director, Process Development

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're not just landing a new role, you become part of a company that'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:

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.

This is a hybrid position in our Somerville, Massachusetts office with regular presence in our lab facility.

SUMMARY

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.  The role must partner successfully cross-functionally within Technical Development and across Technical Operations. 

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.

RESPONSIBILITIES

Strategy

• Provide strategic oversight and day-to-day management of process development workflows internally and externally.
• Collaborate with Analytical Sciences ensuring alignment with process development milestones and regulatory requirements.
• Propose and drive the development of continuous improvements in process, from the smallest detail in execution to an entire unit operation.
• 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.

Continuous Improvement and Process Optimization

• Lead a high-performing team of scientists in the design and development of process improvements, leveraging both internal experiments and external vendors.
• Drive high quality execution of rapid optimization cycles and successful comparability studies.
• Drive innovation in continuous improvement activities whether through novel unit operation development or designing the ideal custom consumable part that improves manufacturability.
• Ensure all new processes are developed with a "right first time" approach to facilitate seamless transition to a GMP environment.

External

• 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.
• Oversight of the design and execution of external process development activities, ensuring development activities are equivalent to internal standards.

Cross-Functional Leadership & Compliance

• Collaborate across CMC to support regulatory submissions and inquiries.
• Author and review high-quality technical reports, SOPs, and CMC sections of regulatory filings.
• 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.
• Manage resource allocation and timelines to ensure program delivery.

Qualifications

• Education: Ph.D. in Chemical Engineering, Biochemical Engineering, Biotechnology or a related scientific discipline.
• 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.
• 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.
• 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.
• Communication: Exceptional verbal and written communication skills, with the ability to translate complex process development data and decisions into strategic insights for senior leadership.

SUMMARY

The Head of Product/Portfolio Management  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 and Head of Product Leadership, you will champion critical portions of Genetix’s leading assets with significant executive visibility and potential for patient impact.

RESPONSIBILITIES

• 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
• Incorporate the long-term vision to develop, optimize, and execute lifecycle management plans
• Drive the development and execution of the integrated cross-functional strategic and operational product plan and timelines
• Integrate cross-functional perspectives, ensuring technical rigor, emerging data, competition, and the evolving landscape in key markets are incorporated routinely to inform product direction
• Partner with functional leads and senior leadership to set product goals aligned with corporate goals
• Foster strong cross-functional team performance, empowering the team while driving alignment, accountability, prioritization, and timely decision making to deliver on product goals
• 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
• Establish clear product communications and deliver critical updates between teams and senior leaders, ensuring strategic alignment and awareness of changes to strategy or timelines
• Partner with corporate communications and the Executive Team to develop product communication strategies, positioning, and messaging
• Drive innovation and maximize long-term value creation by challenging the status quo

QUALIFICATIONS

• 10+ years of industry experience with 5+ years leading drug development programs/products or in life sciences consulting
• BA/BS degree required, advanced degree preferred (MBA, PharmD, PhD, MD)
• Deep understanding of drug development & commercialization
• Cell and gene therapy, rare disease, and hemoglobinopathy experience strongly preferred
• 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
• 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
• 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
• A strong collaborator who communicates in an open, direct, and timely manner
• Flexibility and the ability to nimbly adapt to changing conditions
• Motivated by patient focus and personal commitment to high performance and results
• Possesses high integrity and exceptional work ethic
• Strong experience with program management best practices
• Advanced PowerPoint efficiency

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

SUMMARY 

Manage Quality Approval (qualification) of vendors including R&D, GMP and treatment centers (apheresis collection centers and cell therapy labs) by performing qualification audits and routine (requalification) audits.

Oversee R&D compliance for Genetix clinical studies and Support other Quality Compliance functions, which may include but are not limited to:

• Planning and conducting internal audits
• Assisting with inspection readiness efforts
• Supporting GxP inspection readiness and regulatory inspections

RESPONSIBILITIES

• Collaborate with internal stakeholders (e.g., Apheresis Operations, Commercial, and Clinical Development) and external stakeholders to coordinate and prioritize audits
• Schedule and execute external and internal audits
• Ensure audit observations are communicated, tracked, and remediated in compliance with internal policies and applicable regulatory requirements
• Update approved vendor list, vendor and audit records and develop risk-based audit schedules
• Support annual budget development for outsourced audits
•  Manage Investigator Site Audit Plans for clinical studies
• Develop and present vendor metrics at Management Review
• Oversee R&D quality related activities
• 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
• Serve as compliance lead for clinical studies
• Ensure QA supporting documentation is submitted to the TMF, as applicable
• Serve as QA contact for review and approval of Clinical SOPs
• Perform Regulatory Document Reviews, as applicable
• Provide quality oversight across CGT clinical studies, ensuring GCP compliance, data integrity, and proper documentation throughout clinical execution
• 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.
• Act as the SME and primary point of contact for inspection management, providing real‑time regulatory guidance.
• Partner with Clinical Operations, Regulatory, and Vendor Management teams to identify and mitigate study specific quality risks throughout the trial lifecycle

QUALIFICATIONS

• 8-10 years of experience in gene therapy/cell therapy/biotech/or other related and regulated industry
• 8–10+ years of experience in R&D Quality
• Experience auditing investigator sites, GMP and R&D vendors and apheresis collection centers and cell therapy labs
• Knowledge of FACT/JACIE requirements
• Demonstrated experience in GCP compliance, clinical trial oversight, inspection readiness, and regulatory interaction
• Direct experience leading clinical deviations, CAPAs, change controls, and investigations
• Experience partnering with Clinical Operations, Regulatory, and cross‑functional stakeholders to manage clinical quality risks

 Preferred Qualifications

• Experience with CGT‑specific clinical QA such as:
• Apheresis and cell handling
• Chain‑of‑custody / chain‑of‑identity systems
• Strong understanding of CGT‑specific analytical and technical quality processes and technical Quality oversight.
• Excellent communication and stakeholder influence skills to support global, cross‑functional clinical programs

Position Summary

The Senior Director of Marketing - Gene Therapy will serve as a key commercial leader responsible for driving the strategy across a portfolio of three commercial gene therapy products, with primary responsibility for sickle cell disease (SCD). This role shapes the brands, accelerates patient access, strengthens treatment center engagement, and ensures durable growth across a dynamic ecosystem of patients, caregivers, providers, payers, advocacy partners, and community stakeholders.

The Senior Director of Marketing will also own field training to ensure consistent messaging aligned to the marketing strategy. This individual will lead cross functional optimization efforts, support field execution, and serve as a visible ambassador for the company’s commitment to transforming outcomes in SCD and rare genetic diseases.

This role partners closely with Sales, Market Access, Patient Services, Medical Affairs, Patient & Community Education, and Regulatory to ensure best in class patient and customer support and brand leadership.

Responsibilities

Marketing

• Own the end-to-end brand strategy for Lyfgenia (Primary Focus) and drive portfolio level storytelling that reinforces the company’s leadership in gene therapy and its value to patients, providers, and payers (e.g., disease education, positioning, messaging, value proposition, and competitive differentiation.)
• Develop integrated marketing plans that accelerate appropriate adoption while honoring the history, lived experience, and cultural context of the SCD community.
• Lead development of branded and unbranded campaigns across HCP, patient, caregiver, advocacy, and treatment center audiences including multichannel educational and engagement strategies across patient, HCP, treatment centers, caregiver, and advocacy stakeholders.
• Partner with Field Leadership to strengthen patient pull‑through and end‑to‑end journey support - from treatment consideration through infusion - with messaging, tools, and strategic guidance, ensuring alignment and high‑quality customer engagement.
• Serve as marketing lead for real‑world insights generation, post‑launch optimization, and strategic response to emerging data and competitive shifts.
• Maintain consistent operational excellence and rigorous performance tracking across all marketed programs to diagnose brand performance, guide action, and maximize ROI.
• Partner on congress strategy, symposia planning, and strategic KOL engagements for SCD and rare genetic disorders.
• Chair or co‑lead cross‑functional teams related to brand planning, insight generation, competitive intelligence, and commercialization readiness.
• Lead and develop a high‑performing marketing team, fostering accountability, customer empathy, and operational excellence.
• Manage agencies and vendors, ensuring high‑quality deliverables and efficient use of marketing budget.

Training

• Own the strategic direction of field force training, including new hire and ongoing initiatives, ensuring the field organization is fully equipped to communicate the science, navigate the treatment journey, and support treatment centers with confidence and clarity.

Required Education, Experience, or Qualifications (or equivalent)

Required: 

• Bachelor’s degree required; MBA or advanced life sciences degree preferred.
• 15+ years in biopharma marketing, including launch or post launch leadership in rare disease, gene therapy, or cell therapy.
• Experience leading training initiatives.
• Strong understanding of the SCD landscape, patient journey, cultural and historical dynamics, and operational requirements for the delivery of gene therapy.
• Proven ability to build and execute integrated marketing strategies across HCP, patient, and payer audiences.
• Demonstrated leadership in highly agile, cross functional environments.
• Exceptional communication, strategic thinking, and stakeholder management.

Preferred: 

• Experience within Sickle Cell Disease, Beta-Thalassemia
• Experience in autologous cell and gene therapy

Key Competencies: 

• Strong strategic and analytical acumen required to drive sound, data-driven business decisions
• Ability to translate science into customer driven value
• Cultural competence and authenticity
• Strong influence without authority, including executive-level presence
• Ability to translate strategy into operational plans with discipline
• Genuine Customer and patient empathy
• Team leadership and talent development
• Excellent communication and partnership with internal and external partners  

SUMMARY

The Sr.  Process Engineer MS&T – LVV Manufacturing is a technical leader responsible for sustaining, improving, and scaling GMP processes for Lentiviral Vector (LVV) manufacturing. This role serves as a key process owner across the product lifecycle, providing hands-on technical support for commercial manufacturing, technology transfer and continuous improvement.

You will partner closely with Manufacturing, Quality, Process Development, Analytical Development, Supply Chain, and external partners to ensure processes are compliant, robust, and capable of meeting commercial demand.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

RESPONSIBILITIES

MS&T Leadership

• Lead or support MS&T activities including process characterization, validation, comparability, and continued process verification (CPV)
• Drive process robustness, yield improvement, and cost-of-goods reduction initiatives
• Provide technical leadership for process deviations, investigations, and root cause analysis

• Serve as process SME within MS&T for assigned unit operations and LVV manufacturing processes.
• Provide real-time technical support for GMP manufacturing operations, including investigation of deviations, root cause analysis, and implementation of corrective and preventive actions (CAPAs).

Cross-Functional Collaboration

• Act as a key technical interface with Quality, Regulatory Affairs, Analytical, and External Manufacturing partners
• Support regulatory filings, responses, and lifecycle submissions
• Support technology transfer activities between development and external CDMOs.
• Collaborate with Quality and Regulatory teams to support inspections, audits, and regulatory submissions
• Represent LVV manufacturing in governance forums and senior leadership discussions

Leadership & Collaboration

• Support the overall CMC and manufacturing strategy for LVV production
• Collaborate closely with a CDMO network for technical support for manufacturing activities
• Establish a strong culture of accountability, continuous improvement, and technical rigor

QUALIFICATIONS 

Education and Experience

• Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree
• 5+ years of experience in manufacturing, MS&T or CMC roles in the biopharma industry,
• Deep experience managing contract manufacturing and external supply networks in LVV manufacturing
• Strategic thinker with strong technical skills and a hands-on operational leader

Skills and Competencies

• Demonstrated ability to lead cross-functional teams, manage complex projects, and influence at all levels of the organization
• Deep knowledge of cGMP, GDP, and regulatory requirements (FDA, EMA, ICH)
• Exceptional leadership, communication, and cross-functional collaboration skills

Position Summary:

The Director of Scientific Communications & 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.

Key Responsibilities:

Scientific Communications & Publication Planning

• 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.
• Utilize innovative formats (micro‑learning, interactive pathways, patient‑friendly visuals) and ensure accessibility for diverse audiences
• Maximize the scientific impact of company data via the strategic selection of journals and congresses
• Collaborate with internal/external expertsand vendors to draft content and ensure the scientific accuracy of all data to be presented.
• Maintain the enterprise scientific lexicon and core claims matrix; ensure consistency across materials and channels.

Data Generation: 

• 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. 
• Evaluate and acquire new data sources (clinical trials, RWD, registries) to support evidence plans.
• 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.
• 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.
• Establish content measurement frameworks (reach, engagement, knowledge lift, practice intent) and continuous improvement loops.
• 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.
• Ensure all evidence generation activities follow ICH-GCP guidelines, SOPs, and compliance requirements for post-marketing research.

Cross‑Functional Partnership

• Collaborate within Medical Affairs and with Clinical Development, Regulatory, Pharmacovigilance, Commercial, Market Access, and Patient Advocacy to ensure accuracy and balance across communications.
• 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)..

Associated Responsibilities:

• Own Med Affairs content as well as related SOPs and work processes.
• Ensure adherence to policies and procedures via audits.
• Develop and deliver monthly and quarterly updates to track progress and align on key priorities.
• Develop and manage department budget
• Lead or co‑lead medical review for scientific materials; partner with Legal/Compliance/Regulatory on clear SOPs and guardrails.

Qualifications:

• MD, PharmD, PhD in a biomedical field; experience in hematology or Oncology or cell and gene therapy strongly preferred.
• 8+ years in Medical Affairs/Scientific Communications within biopharma, including publication planning and medical education leadership.
• Understanding of hemoglobinopathies (SCD, β‑thalassemia), cell‑based gene therapy modalities, safety monitoring (including long‑term follow‑up), and registry/RWE experience is preferred
• Experience building omnichannel education programs.
• Fluency with compliance frameworks (GPP, ICMJE, ACCME, OIG, PhRMA Code) and medical review processes.
• Exceptional scientific writing, editorial judgment, and stakeholder management; comfortable engaging with KOLs, investigators, and advocacy leaders.

Position Description

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.

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.

This is a full-time hybrid position (3 days a week) in our Somerville, Massachusetts office.   

Specific Job Duties

• 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
• 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
• Lead regulatory CMC activities supporting commercial manufacturing, supply continuity, and inspection readiness, including responses to health authority questions and commitments
• 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
• Partner closely with Pharmaceutical Sciences, Technical Operations, Quality, Supply Chain, and Program Teams to ensure alignment between regulatory strategy and operational execution
• Provide regulatory oversight and approval of post-approval CMC documentation, ensuring consistency with approved dossiers and global regulatory requirements
• Drive adherence to global CMC regulatory standards and guidance (FDA, EMA, ICH) applicable to commercial and post-approval gene therapy products
• Contribute to and lead regulatory intelligence efforts related to post-approval expectations, emerging guidance, and evolving inspection trends impacting gene therapy products
• Mentor and develop Regulatory CMC team members, building scalable post-approval regulatory capabilities to support Genetix portfolio growth
• Represent Regulatory CMC on cross-functional governance forums, providing clear, risk-based regulatory recommendations

Required Education, Experience, or Qualifications

• Bachelor’s or Master’s degree in life sciences (biochemistry, chemistry, biology, biochemical engineering, or related field); PhD preferred
• Minimum of 15 years of biopharmaceutical industry experience, with significant experience in post-approval CMC regulatory affairs for cell and gene therapies
• Demonstrated experience leading post-approval submissions, including supplements, variations, and annual reports, and supporting health authority GMP inspections
• Strong working knowledge of commercial manufacturing and lifecycle management for complex biologics and gene therapy products
• Excellent written and verbal communication skills with proven ability to translate complex technical issues into clear regulatory strategies
• Proven leadership skills, including strategic thinking, people development, cross-functional influence, and decision-making in a matrix environment
• Deep understanding of GMP, CMC regulatory requirements, and global regulatory frameworks (FDA, EMA, ICH)
• Highly organized, detail-oriented, and solution-focused, with the ability to manage multiple priorities and drive execution to completion

SUMMARY

The Senior Director, Analytical Sciences will provide strategic technical and operational leadership for the internal and external analytical development/GMP testing functions supporting our company’s gene therapy product portfolio. This role will oversee the design and execution of internal analytical testing for process development, drive the innovation of new analytical assays, and technically drive the end-to-end transfer and validation of these assays to external QC laboratories including technical investigations supporting GMP release.  The role must partner successfully cross-functionally within Technical Development and across Technical Operations.  This is a full-time hybrid position (3 days a week) in our Somerville, Massachusetts office.

The ideal candidate will bring deep expertise in cell and gene therapy (CGT) analytical development, a track record of successful assay development and tech transfers, and the leadership acumen to bridge the gap between early scientific assay development and commercial QC operations.

RESPONSIBILITIES

Analytical Strategy

• Provide strategic oversight and day-to-day management of analytical workflows internally and externally
• Define the analytical strategy for ensuring alignment with process development milestones and regulatory requirements
• Partner closely with Process Development to provide rapid analytical testing for process optimization and comparability studies.
• Propose and drive the development of life cycle management of analytical control strategies, including assay updates and assay replacements
• Actively participate in establishing the appropriate technical rigor and additional characterization assays needed to support strategic decisions for analytical comparability

New Assay Development & Innovation

• Lead a high-performing team of scientists in the design, development, qualification, and routine testing of novel assays
• Drive innovation in analytical platforms to improve assay sensitivity, throughput, and robustness, specifically tailored for complex cell therapies and considering the appropriate level of automation
• Ensure all new methods are developed with a "right first time" approach to facilitate seamless transition to a GMP environment

External (from Tech Transfer to Investigations)

• Acts as the ultimate technical authority for Analytical Sciences for the technical transfer of analytical methods from internal to external quality control laboratories
• Oversee the design and execution of method validation at external sites, ensuring successful implementation and compliance with regulatory standards.
• Manage troubleshooting, OOS/OOT investigations, and method lifecycle management with a focus on removing barriers to ensure the path to curative treatments remains clear.

Cross-Functional Leadership & Compliance

• Collaborate across CMC to support regulatory submissions and inquiries.
• Author and review high-quality technical reports, SOPs, and CMC sections of regulatory filings.
• Build and mentor a world-class analytical sciences team, fostering individual team member career development while in parallel maintaining a culture of scientific rigor and operational excellence.
• Manage resource allocation and timelines to ensure program delivery.

 Qualifications

• Education: Ph.D. in Biochemistry, Molecular Biology, Analytical Chemistry, or a related scientific discipline.
• Experience: 10+ years of progressive experience in the biopharmaceutical industry, with at least 5 years in a people management role specifically within Analytical Development for Cell and Gene Therapies, with title commensurate with experience.
• Technical Expertise: Deep hands-on and strategic knowledge of cell therapy analytical techniques (Multicolor Flow Cytometry, ddPCR, Cell-based Potency, ELISA, CFU, etc.). Ideal candidate will have prior CD34+ and/or viral vector experience.
• Track Record: Proven success in transferring and validating assays at external CDMOs/CROs and supporting successful regulatory filings (IND/BLA/MAA) including resolving root cause investigations.
• Communication: Exceptional verbal and written communication skills, with the ability to translate complex analytical data into strategic insights for senior leadership.

SUMMARY

The QA Manager, Training (LMS) will be responsible for the oversight, administration, and continuous improvement of the company’s electronic Learning Management System (Compliance Wire) to ensure compliance with FDA, EMA, ICH, and other global regulatory expectations for Cell and Gene Therapy (CGT) operations. This role ensures that training programs are effectively designed, executed, and documented to support a state of control across GxP functions, including Manufacturing, Quality, Supply Chain, MSAT, and Clinical Operations.

The ideal candidate has strong experience with Compliance Wire, GxP training programs, and QA systems within advanced therapies, including CGT, autologous/allogeneic platforms, or viral vector manufacturing environments.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

RESPONSIBILITIES

• Serve as the system owner for the GxP Learning Management System (Compliance Wire), ensuring validated state, data integrity, and compliance with 21 CFR Part 11 and EU Annex 11 requirements.
• Develop, implement, and maintain training processes, procedures, and work instructions aligned with CGT regulatory requirements.
• Ensure that training curricula, assignments, and qualification requirements are current, risk-based, and aligned with job roles.
• Oversee training content lifecycle, including creation, review, approval, periodic review, and archival in Compliance Wire.
• Monitor training compliance metrics and ensure timely remediation of overdue or incomplete training.
• Collaborate with QA, Manufacturing, MSAT, QC, Supply Chain, and Clinical Operations to ensure training alignment with operational readiness for CGT activities.
• Support internal and external regulatory inspections by providing training records, system documentation, and SME-level responses.
• Lead deviation investigations or CAPAs related to LMS or training failures.
• Ensure GMP/GDP compliance for employees, contractors, and external partners involved in CGT workflows.
• Lead the development of competency-based training frameworks tailored for CGT manufacturing and quality operations.
• Implement improvements to training effectiveness, onboarding workflows, and qualification programs for roles such as aseptic operators, vector manufacturing personnel, and QTC oversight teams.
• Partner with functional leaders to evaluate training gaps and implement proactive training solutions.
• Manage periodic system evaluations and support upgrades or configuration changes within Compliance Wire.
• Act as the primary point of contact for all LMS-related questions and training system capabilities.
• Provide guidance to SMEs and content owners on training content development, assessments, and multimedia materials.
• Deliver training to employees on the use of Compliance Wire and GxP training requirements.

QUALIFICATIONS 

• Bachelor’s degree in Life Sciences, Biotechnology or a related field.
• Minimum 5 years of experience in biotechnology, pharmaceutical, or life sciences industry.
• 5–8+ years of Quality Assurance or training systems experience in a GxP environment; at least 3 years working specifically with Compliance Wire.
• Strong understanding of Cell and Gene Therapy regulations, including FDA guidance for ATMPs, EU ATMP frameworks, GTP (21 CFR 1271), and GMP/GDP expectations.
• Experience supporting audits and regulatory inspections.
• Experience in autologous or allogeneic CGT manufacturing, viral vector production, or Qualified Treatment Center (QTC) training programs.

 Preferred

• Experience designing competency-based training programs for high-risk operations (e.g., aseptic processing, cryopreservation, chain-of-custody/chain-of-identity workflows).
• Strong communication, problem‑solving, and cross‑functional leadership skills.
• Proactive approach to problem-solving, training effectiveness, and continuous improvement.

ABOUT THE ROLE

The Medical Affairs group is driven by our responsibility to patients, our engaging science, and our opportunity to help the scientific community understand what Genetix is working on. Medical Affairs team serves as a trusted and reliable source of information about Genetix’s science to healthcare providers around the world. Through scientific and medical communications, we link the innovative science from our labs and clinical research to the patients in the clinic.

As the only company with three FDA approved gene therapy products, we have accomplished a lot and now we are driven to bring these therapies to a growing number of deserving patients. They have waited a long time for the cutting-edge science to be brought to the clinic, a goal now accomplished by amazing Genetix team. We move with a sense of urgency that reflects our commitment to people suffering from severe genetic diseases and we remember to support each other and have fun doing it!

RESPONSIBILITIES

As a Regional Medical Director Gene Therapy, you would be an integral part of Medical Affairs and will develop and implement the medical strategy for a gene therapy portfolio, ensuring alignment across various internal and external functions.

• Develop and execute Medical Affairs strategy: This includes contributing to the comprehensive strategy for gene therapy across sickle cell disease (SCD) and transfusion dependent thalassemia (TDT) ensuring alignment with the overall company strategy and develop medical plans with company’s goals and milestones. 
• Build external relationships: Develop external relationships to provide scientific and clinical information on our therapies to key HCP and bring actionable insights from the KOL and treating physicians. Scientific exchange is a key element of this role.
• Provide medical leadership to Genetix’s cross-functional teams: Offer medical expertise and input to other teams including commercial, clinical, operations, payor, and advocacy, ensuring a strong and consistent medical voice is represented. 
• Contribute to medical education and communications: Develop and support the creation of medical education materials, scientific communications, and publications. 
• Researching and exploring scientific presentations and publications: Collect the latest data from publications and presentations, gather competitive intelligence in the relevant areas of activity, and summarize key findings for the internal team.
• Ensure compliance: Maintain compliance with applicable company policies and regulations. Ensure that activities including the management, generation, and dissemination of clinical and non-clinical data are conducted with integrity and scientific accuracy. 

QUALIFICATIONS

• Medical degree (MD or equivalent) degree, or advanced scientific or clinical training (for example, Ph.D., PharmD or MSN) with at least 5 years of previous combined experience in relevant patient care and/or Medical Affairs.
• Ability to build and maintain relationships with key opinion leaders and other external stakeholders. 
• Previous experience in Hematopoietic Stem Cell Transplantation, Cell and Gene Therapy or other biologic therapies is required; experience with hemoglobinopathies such as TDT and SCD are also valued.
• Strong scientific expertise and the ability to explain complex concepts clearly is required.
• Residence in Texas, Southern California or Northeast US preferred.
• Must have the ability to travel frequently to the treatment centers, referring practices, academic conferences and other engagements.
• Excellent communication, presentation, and interpersonal skills. Ability to lead technical and business discussions internally and externally.

SUMMARY

The Manager, Quality Systems, is responsible for overseeing key elements of the Quality Management System (QMS) that support manufacture, and release of gene therapy products. This role manages the end‑to‑end Complaint and Recall programs, ensures accurate and timely Quality Metrics reporting, drives closure of open quality system records, and supports continuous improvement initiatives and SOP lifecycle management.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

RESPONSIBILITIES

• Oversee intake, triage, investigation, and closure of product quality complaints. Ensure complaint investigations are thorough, scientifically sound, and completed within required timelines.
• Manage the recall initiation, assessment, communication, and documentation process in compliance with regulatory expectations. Maintain recall readiness, including procedures, training, and mock recall exercises.
• Lead collection, analysis, and reporting of Quality Metrics (e.g., complaint cycle time, deviation aging, CAPA effectiveness)
• Lead routine cross‑functional meetings to review and drive timely closure of deviations, CAPAs, change controls, complaints, and other QMS records. Track action items, assign ownership, and ensure adherence to deadlines.
• Serve as the QA reviewer/approver of internal quality system records.
• Lead and support SOP revisions ensuring clarity, compliance, and alignment with business processes.
• Facilitate cross‑functional reviews, training, and implementation of updated procedures.
• Support quality improvement initiatives that enhance QMS performance, efficiency, compliance, and data integrity.
• Support internal audits and inspections.

QUALIFICATIONS

• Bachelor's or Master's degree in Life Sciences, Engineering, or related field.
• Minimum 5 years of experience in biotechnology, pharmaceutical, or life sciences industry.
• Experience with electronic QMS platforms (e.g., Veeva Vault).
• Strong communication, problem‑solving, and cross‑functional leadership skills.

SUMMARY

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&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. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

RESPONSIBILITIES

• Accounting for and supporting the operational aspects for the Inventory cycle including COGs, Bill of Materials (BOM’s), inventory management & reconciliations, variance
• Responsibility for all aspects of the implementation of the inventory and COGS modules of NetSuite
• Managing and improving cost accounting models
• Managing the monthly, quarterly, and annual financial close process for costing and inventory module, to ensure accuracy of transactions, journal entries, account
• Generating accurate and timely inventory and costing reports to support continuous improvement initiatives.
• Collaborating with the finance team when preparing financial analysis of manufacturing variances, gross margin, and excess and obsolete inventory.
• Reviewing standard costs quarterly
• Successfully partnering with FP&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.
• Driving and supporting internal manufacturing finance controls and processes with a continuous improvement methodology.
• Interacting with internal and external auditors, providing various analysis and audit schedules to ensure compliance with internal control procedures
• Other related tasks as needed

 QUALIFICATIONS

• 7+ years of experience in cost accounting, with at least a Bachelor’s degree in
• Certification in Cost Accounting preferred but not
• Experience in cost accounting for the biotech / pharmaceutical manufacturing industries that has both internal and external manufacturing and testing costs.
• Experience building and leading a
• Are familiar with NetSuite.
• Excellent business partnership and team development
• Results-orientation with the proven ability to execute on collaborative projects and develop subject matter expertise.

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.

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.

This role is a full time hybrid position (3 days a week in the office) located in our Somerville, Massachusetts office.

RESPONSIBILITIES

• Lead Commercial CMC teams and drive execution of CMC activities aligned with program, regulatory, and supply objectives
• Develop, maintain, and actively manage integrated CMC project plans, including timelines, dependencies, critical path activities, and decision points
• Establish and maintain a CMC risk registry; proactively identify risks, define mitigation strategies, and escalate issues to prevent program delays
• Lead cross‑functional coordination across Manufacturing, Quality, Analytical Development, Regulatory CMC, Supply Chain, and external partners to resolve complex CMC issues
• Manage CMC execution in collaboration with key external partners, ensuring accountability to scope, timeline, and deliverables for key commercial milestones
• Prepare and deliver concise, data‑driven updates to senior leadership and governance forums on CMC status, risks, and execution options
• Co‑lead CMC team meetings and governance forums, applying strong meeting management practices to enable timely decision‑making and follow‑through
• Promote a culture of ownership, accountability, and continuous improvement across CMC project teams

QUALIFICATIONS

• Bachelor’s, Master’s, or Ph.D. in life sciences or a related discipline, or equivalent industry experience
• Minimum of 6 years of biopharmaceutical industry experience; experience supporting late‑stage or commercial programs strongly preferred
• At least 2 years of project management experience or demonstrated success leading cross‑functional teams in a fast‑paced biotech or pharmaceutical environment
• Proven ability to manage complex, cross‑functional programs, identify and mitigate risk, and drive execution in a matrixed organization
• Strong working knowledge of CMC development, manufacturing, and quality concepts; cell and gene therapy experience is a strong plus
• Proficiency with project management and collaboration tools, including Microsoft Project, PowerPoint, Excel, and OneNote
• Strong organizational skills with the ability to manage multiple priorities and shifting timelines
• Demonstrated ability to translate complex technical plans into clear, actionable communication for technical and non‑technical stakeholders

SUMMARY 

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.

This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

RESPONSIBILITIES

• 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
• 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
• Ensuring an appropriate, consistent, and harmonized quality approach is standard across all QTCs through Quality Agreement initiation, review, execution, and maintenance
• Tracking and trending quality system event generation at QTCs, providing periodic updates to management
• Reviewing and approving documents including apheresis collection records, policies and procedures, deviations, investigations, and partner CAPA action plans
• Reviewing and approving internal deviations, CAPA, and Change Control, performing Failure Mode and Effect Analyses, root cause analyses, and CAPA effectiveness check as required
• 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
• Assisting with internal and external Quality Audits
• Fostering a Quality mindset throughout the company by ensuring consistent, risk-based and innovative thought processes are employed to advise and make decisions)

QUALIFICATIONS 

• BS/BA and a minimum of 7+ years working experience in cell therapy (or applicable) environment. Experience in a hospital setting preferred
• Knowledge of FACT accreditation requirements and their application for collection of apheresis and/or cell therapy lab preferred
• Strong knowledge of GTP regulations and guidance documents
• Experience with quality agreements
• Demonstrated leadership within cross-functional teams with identifying areas of improvement, then participating in the design and delivery of improvements
• Technical understanding of biopharmaceutical production, with experience in cell and gene therapy a plus.

SUMMARY

The Lead Specialist, QA Operations Lot Disposition supports timely and compliant release of externally manufactured drug product, viral vector materials, and vendor‑supplied starting materials used in gene therapy programs. This role serves as a subject‑matter resource within the team, guiding junior reviewers, coordinating documentation flow, and helping ensure right‑first‑time disposition packages. The Lead Specialist partners closely with External Manufacturing, Quality, Supply Chain, and Technical Operations to keep batch documentation on track and audit‑ready.

This is a full-time hybrid position (3 days a week) in our Somerville, Massachusetts office.   

RESPONSIBILITIES

• Coordinate completion and review of lot disposition packages, ensuring timely batch record, CoA/CoC, deviation, and supporting documentation readiness.
• Perform detailed quality review of batch records and supporting documents for external DP and viral vector manufacturing.
• Support review and release of vendor‑provided starting materials and raw materials used in gene therapy processes.
• Serve as a point of contact for documentation questions from internal teams and external manufacturing partners.
• Track lot status and proactively identify risks, gaps, or delays in documentation availability.
• Assist with investigation summaries, data reconciliation, and communication of document issues to cross‑functional teams.
• Support audit and inspection readiness by ensuring disposition files remain complete, accurate, and organized.
• Provide documentation and information during internal/external audits and help prepare responses.
• Drive and support process improvements and operational excellence initiatives related to the documentation and disposition workflow.
• Mentor or guide junior specialists on documentation expectations, quality standards, and system navigation.
• Support User Acceptance Testing and implementation of a digitalized CGT lot disposition process
• Proactively identify and drive operational excellence opportunities within the lot disposition process to enhance efficiency, reduce cycle time, and strengthen compliance.

QUALIFICATIONS

• Bachelor’s degree in a STEM discipline preferred (Biology, Biotechnology, Chemistry, Engineering).
• 4+ years of experience in a regulated biopharmaceutical, gene therapy, biologics, or medical device environment.
• Hands‑on experience with GMP documentation, batch record review, or lot disposition activities.
• Familiarity with external manufacturing environments (CMOs/CDMOs).
• Proficiency with electronic systems such as eQMS, document management platforms, or LIMS.
• Strong organizational skills with excellent attention to detail.
• Ability to interpret procedures, quality standards, and regulatory expectations.
• Effective communication skills for cross‑functional and external partner interaction.

 PREFERRED QULIFICATIONS:

• Experience with viral vector or biologics manufacturing.
• Exposure to raw material qualification or material release processes.
• Understanding of FDA regulations for advanced therapies.