Our client—a clinical-stage genomic medicine company—recently achieved a major regulatory milestone for its lead gene therapy program targeting a rare lysosomal storage disorder. Following positive clinical trial data, the FDA has aligned with the company on an Accelerated Approval pathway, using an intermediate clinical endpoint as the basis for submission. A Biologics License Application (BLA) is expected in 2026. Recent regulatory meetings have also clarified the Chemistry, Manufacturing, and Controls.

Our client is seeking a mission-driven and scientifically grounded Sr. Director to lead the formulation, MSAT, and fill/finish operations for late-stage gene therapy drug products. This leader will drive execution across formulation development, technology transfer, CDMO management, and regulatory readiness.

Key Responsibilities
- Lead the development and optimization of gene therapy formulations with a focus on stability and shelf life, especially for viral vector-based products (e.g., AAV).
- Oversee Fill/Finish strategy and execution in collaboration with CDMOs, with particular emphasis on aseptic processes and frozen product handling.
- Provide technical leadership to a team of 6 scientists; manage workload, performance development, and team structuring.
- Own the MSAT function and ensure late-stage readiness for regulatory filings including BLA.
- Serve as the primary technical liaison to Thermo Fisher and other CDMOs; influence, educate, and drive performance externally.
- Lead long-range planning for formulation department infrastructure: budgets, resource allocation, equipment, and cross-functional integration (Clinical, QA, Regulatory).

Key Requirements
- PhD or MS in Pharmaceutical Sciences, Chemistry, or related field with 10+ years of relevant experience.
- Demonstrated success in formulation development of biologics or gene therapy products; deep AAV knowledge preferred.
- Strong experience in MSAT, Fill/Finish, and CMC strategies for viral vector drug products.
- Late-stage development experience including IND amendments, BLA preparation, and regulatory interactions.
- Proven ability to manage and mentor technical teams.
- Effective communicator and collaborator, capable of influencing CDMO partners and internal stakeholders.
Willingness to be onsite most days and flexible to travel between multiple locations in the San Francisco Bay Area.
- Open to candidates requiring immigration visa transfer.

Application Instructions:
https://nwrp.catsone.com/careers/2072-General/jobs/166933

Target Pay Range: $265,000 - $312,000 per year
The anticipated salary range is for candidates who will work in the San Francisco Bay Area work locations. The final salary offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and length of experience with the job, type and length of experience within the industry, education, etc. The salary range may not apply to remote positions that work in other states. 

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