Associate Director, Process Validation

The Associate Director, Process Validation and Risk Management will lead and facilitate commercial process validation and risk management activities across Vaxcyte's end-to-end manufacturing processes. This role focuses on technical strategy, execution, and cross-functional coordination to support commercial readiness, regulatory compliance, and lifecycle management.

What You Will Do

Provide strategic and scientific leadership for process validation (PPQ, CPV, lifecycle validation) across commercial programs. Lead and facilitate execution of validation strategies to support technology transfer, site readiness, and product launch.

Why It Might Be a Fit

This position requires a strong experience in biologics/vaccine manufacturing, including process validation, MSAT, technical operations, or late-stage development. The incumbent will provide leadership to ensure the organization is equipped to effectively design, execute, and communicate process validation and risk management strategies to internal stakeholders, external partners, and regulatory agencies.

Requirements

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline
• 9+ years of relevant experience for Ph.D., 11+ years for M.S./M.A., or 14+ years for B.S./B.A.
• Strong experience in biologics/vaccine manufacturing
• Process validation (PPQ/CPV)
• MSAT, technical operations, or late-stage development
• Technology transfer and commercialization
• Experience in quality risk management (ICH Q9) and regulatory expectations
• Demonstrated leadership in matrixed or cross-functional team environments
• Ability to apply deep technical knowledge to develop strategies and drive execution
• Strong problem-solving, organizational, and strategic planning skills
• Excellent communication and stakeholder engagement skills
• Ability to analyze data and align stakeholders with organizational strategy
• Innovative and entrepreneurial mindset to drive continuous improvement

Benefits

• Comprehensive benefits
• Equity component