Exec Director, Viral Vector Process Development
About The Position
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. This role is 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) and 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 and platform innovations and emerging delivery technologies. 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, and 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. 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. 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, and collaboration and transparency. 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, and executive leadership. Build credibility as a trusted partner and advisor, both internally and externally. Represent the organization in external collaborations, partnerships, and industry forums.
Requirements
- 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
Nice To Haves
- Exposure to in vivo gene delivery platforms
- Sound knowledge in RVV development and CMC aspects
- 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
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
Benefits
- company-sponsored medical, dental, vision, and life insurance plans
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What This Job Offers
Job Type
Full-time
Career Level
Executive
Education Level
Ph.D. or professional degree
