Exec Director, Viral Vector Process Development

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.
  • Oversee LVV life cycle management and manufacturing support capabilities.
  • Drive process scale-up and technology transfer to clinical and commercial manufacturing sites (internal and external).
  • 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.
  • 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.

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
• Strong understanding of: Viral vector development across phases, Analytical characterization strategies, Manufacturing and tech transfer considerations for viral vector
• 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