Vaxcyte

Founded in 2013, Vaxcyte is a clinical-stage vaccine innovation company based in San Carlos, California, dedicated to eliminating bacterial infections such as i

Associate Director, Process Validation

Location

California

Posted

17 hours ago

Salary

$174K - $203K / year

Seniority

Lead

Postgraduate Degree9 yrs expEnglish

Job Description

Associate Director, Process Validation

Vaxcyte

• 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. • Ensure alignment of validation activities with regulatory expectations and lifecycle management plans. • Develop and implement risk management frameworks, tools, and processes in collaboration with Quality. • Lead cross-functional risk assessments to identify, evaluate, and mitigate operational, technical, and regulatory risks. • Monitor and communicate risk trends and key risk indicators to stakeholders. • Support commercial manufacturing operations by ensuring processes remain in a validated and controlled state. • Contribute to lifecycle management activities, including process improvements and continued process verification. • Collaborate with Regulatory, CMC, Quality, Supply Chain, Procurement, and Engineering to support commercialization and supply continuity. • Partner with internal teams and external CMOs to ensure alignment on validation and risk strategies. • Provide guidance for validation of processes, systems, facilities, and methods within the commercial organization. • Support deviation investigations, ensuring timely resolution and sustained compliance. • Contribute to authoring and reviewing regulatory filings and responses to health authorities. • Effectively communicate the scientific and commercial rationale for validation and risk management strategies. • Provide leadership for execution of process validation and comparability activities, ensuring data integrity and compliance. • Provide guidance on raw material qualification strategies to ensure supply reliability. • Support validation activities across internal and external manufacturing networks. • Communicate process validation performance and risk insights to key stakeholders. • Build strong working relationships and influence across a matrixed organization. • Contribute as a key member of the Global MSAT organization to enable successful commercialization.

Job Requirements

  • Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 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, including:
  • 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
  • An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.

Benefits

  • The compensation package will be competitive and includes comprehensive benefits and an equity component.

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