Job Description
This role is accountable for end-to-end viral vector development, from construct design through clinical and commercial manufacturing support, and serves as a key partner across Research, Product Teams, Technical Operations, and Analytical functions.
The leader will balance deep technical expertise with executive-level influence, ensuring robust, scalable vector platforms while building a high-performing organization capable of supporting both ex vivo and emerging in vivo applications.
Reporting & Location
- Reports to: SVP, Global Head of Process Development
- Location: Santa Monica, CA Or Oceanside, CA
- On-site presence required
Key Responsibilities
Technical & Scientific Leadership
- Accountable for technical strategy for viral vector platforms across clinical and commercial scale, including complex tech transfers, external manufacturing partnerships, and late‑stage manufacturing readiness.
- Provide deep expertise in lentiviral vector (LVV) design, including construct architecture, promoter selection, and transgene optimization
- Lead viral vector process development, including:
- Upstream production systems (transient and stable)
- Downstream purification and recovery operations
- Drive process scale-up and technology transfer to clinical and commercial manufacturing sites (internal and external)
- Oversee LVV life cycle management and manufacturing support capabilities
- Lead initiatives to improve viral vector productivity, robustness, and cost of goods
- Advance next-generation capabilities, including:
- In vivo viral vector development
- Platform innovations and emerging delivery technologies
Cross-Functional & Product Development Leadership
- Ensure viral vector development decisions are optimized across the full cell therapy value chain, from transduction efficiency and cell performance to manufacturing robustness and CMC sustainability.
- Provide strategic leadership for viral vector on cross-functional Product Teams
- Partner closely with:
- Research to translate early concepts into developable and scalable vector designs
- T cell process development to align vector performance with cellular outcomes
- Analytical development to ensure appropriate characterization and control strategies
- Contribute to integrated product development, ensuring vector design and process decisions align with clinical and commercial objectives
- Drive alignment across functions in a matrixed environment, balancing competing priorities while maintaining product focus
CMC & Regulatory Engagement
- Strong working knowledge of cGMP regulations and compliance systems related to viral vector development, including inspection readiness, audit support, and direct engagement with regulatory agencies.
- Contribute to LVV CMC strategies, including phase-appropriate viral vector development and scale-up approaches
- Support regulatory filings and health authority interactions as a technical expert
- Provide input into comparability strategies for process changes, site transfers, and lifecycle evolution of LVV
Organizational Leadership & Talent Development
- Provide leadership oversight for viral vector development laboratories and GMP‑adjacent environments, ensuring facility readiness, compliance, and operational excellence in support of clinical and commercial programs.
- Demonstrated experience leading large organizations within a highly matrixed cell and gene therapy environment.
- Build, lead, and scale a high-performing viral vector development organization
- Recruit, develop, and retain top scientific and leadership talent
- Coach and develop future leaders, ensuring depth and succession within the organization
- Foster a culture of:
- Scientific rigor and accountability
- Ownership and execution
- Collaboration and transparency
Leadership, Communication & Executive Influence
- Demonstrate strong executive presence, with the ability to clearly communicate complex technical concepts to diverse audiences
- Influence decision-making at senior leadership and governance levels, providing clear, balanced perspectives on risks, trade-offs, and options
- Drive clarity in ambiguity, enabling teams to make timely and well-informed decisions
- Communicate effectively across:
- Technical teams
- Cross-functional stakeholders
- Executive leadership
- Build credibility as a trusted partner and advisor, both internally and externally
- Represent the organization in external collaborations, partnerships, and industry forums
Basic Qualifications
- PhD in Biochemical Engineering, Molecular Biology, Virology, or related field with 15+ years of experience (or MS with 18+ years)
- Extensive experience in viral vector development and manufacturing support for cell and/or gene therapy
- Demonstrated expertise in LVV and/or RVV systems
- End-to-end experience from early development through commercialization
- Strong understanding of:
- Viral vector development across phases
- Analytical characterization strategies
- Manufacturing and tech transfer considerations for viral vector
- Experience leading cell therapy programs (e.g., CAR-T)
- Proven ability to lead in a highly matrixed, cross-functional environment
- Track record of influencing portfolio and strategic decisions for successful drug development
Preferred Qualifications
- Exposure to in vivo gene delivery platforms
- Sound knowledge in RVV development and CMC aspects
Leadership Attributes
- Enterprise mindset — prioritizes product and patient impact over functional optimization
- Technical depth with judgment — knows when to go deep and when to elevate
- Clarity and decisiveness — simplifies complexity into actionable direction
- Talent builder — develops leaders, not just teams
- Strong influencing skills across matrixed environments
- Ability to integrate strategy with execution
