Job Description
- Accountable for end-to-end viral vector development (construct design through clinical and commercial manufacturing support), partnering across Research, Product Teams, Technical Operations, and Analytical functions.
- Balance deep technical expertise with executive-level influence to ensure robust, scalable vector platforms and build a high-performing organization supporting ex vivo and emerging in vivo applications.
Key Responsibilities
- Define technical strategy for viral vector platforms across clinical/commercial scale, including tech transfers, external manufacturing partnerships, and late-stage manufacturing readiness.
- Provide LVV design expertise (construct architecture, promoter selection, transgene optimization).
- Lead process development: upstream (transient and stable) and downstream purification/recovery.
- Drive process scale-up and tech transfer to internal/external manufacturing sites.
- Oversee LVV life cycle management and manufacturing support.
- Improve viral vector productivity, robustness, and cost of goods.
- Advance next-generation capabilities (in vivo vector development; platform/delivery innovations).
- Optimize decisions across the cell therapy value chain (transduction efficiency, cell performance, manufacturing robustness, CMC sustainability).
- Provide CMC and regulatory strategy input (cGMP compliance, inspection readiness, audit support; regulatory filings; comparability strategies).
- Provide leadership oversight for viral vector development labs/GMP-adjacent environments; build/scale the organization, recruit/develop/retain talent, and coach future leaders.
Basic Qualifications
- PhD (Biochemical Engineering, Molecular Biology, Virology, or related) + 15+ years; or MS + 18+ years.
- Extensive viral vector development and manufacturing support experience for cell and/or gene therapy.
- Demonstrated LVV and/or RVV expertise; end-to-end development to commercialization.
- Strong knowledge of viral vector development across phases, analytical characterization, and manufacturing/tech transfer.
- Experience leading cell therapy programs (e.g., CAR-T).
Preferred Qualifications
- Exposure to in vivo gene delivery platforms.
- Sound knowledge in RVV development and CMC aspects.
Location/Reporting
- Santa Monica, CA or Oceanside, CA; on-site presence required.
- Reports to: SVP, Global Head of Process Development.