Sr. Director, Manufacturing and MST (4437)

Genetix Biotherapeutics•Somerville, MA

8d•Hybrid

About The Position

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. SUMMARY The Senior Director of Manufacturing & MS&T (Manufacturing Science & Technology) is a strategic and operational leader responsible for overseeing drug product commercial manufacturing operations, technology transfer, and process development support for the company’s gene therapy product portfolio. This role ensures that manufacturing processes are robust, compliant, scalable, and continuously improved to meet commercial demand and regulatory expectations. The Senior Director will partner cross-functionally across Technical Operations and Qulaity to drive high-quality execution across internal development and external manufacturing networks. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

Requirements

Bachelor’s degree in Engineering, Life Sciences, or related field; advanced degree (MBA or MS) preferred
15+ years of experience in manufacturing, MS&T or CMC roles in the biopharma industry, with at least 7 years in a senior leadership role
Deep experience managing contract manufacturing and external supply networks, ideally in cell and gene therapy or other complex modalities
Strong understanding of GMP compliance, quality systems, and regulatory expectations for advanced therapies
Strategic thinker with strong financial acumen and a hands-on, results-driven leadership style
Demonstrated ability to lead cross-functional teams, manage complex projects, and influence at all levels of the organization
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
Strong demonstrated leadership across multiple functions within Technical Operations
Strategic thinker with hands-on operational expertise in manufacturing of cell & gene therapies

Nice To Haves

Experience with closed, automated, or semi-automated cell therapy manufacturing platforms

Responsibilities

Provide strategic oversight and day-to-day management of GMP manufacturing for gene therapy products across internal development labs and CDMOs.
Ensure operations meet safety, quality, cost, and delivery targets while maintaining a culture of compliance and operational excellence.
Develop and execute manufacturing readiness strategies commercial production, including staffing, capacity planning, and resource management.
Oversee a team that leads investigations, root cause analyses, and CAPA implementation for manufacturing deviations.
Oversee Person-in-Plant leadership to ensure proper governance and oversight of CDMO manufacturing
Serve as the technical owner of commercial and late-stage processes, providing subject-matter leadership for drug product manufacturing
Oversee technology transfer activities from Process Development to GMP manufacturing, ensuring seamless scaling and process robustness.
Oversee process validation strategy, continued process verification (CPV), and lifecycle management.
Drive process improvements, new technologies, and comparability studies to enhance consistency, yield, and cost efficiency
Partner closely with Quality to ensure alignment on compliance, product release timelines, and regulatory inspections.
Collaborate with Regulatory Affairs to prepare CMC sections of regulatory submissions (IND, IMPD, BLA/MAA) and respond to health authority questions.
Engage with Supply Chain/Logistics on raw material strategy, vendor qualification, and secondary material planning
Provide executive-level communication and program updates to senior leadership and governance committees
Act as a key member of the CMC Drug Product Team, contributing to the overall CMC and manufacturing strategy
Foster a high-performance culture, setting clear expectations, developing talent, and enabling team growth
Establish a strong culture of accountability, continuous improvement, and technical rigor