Associate Director, Process Validation, Risk Management

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🕒 April 3

🏄 California – Remote

🏄 California – Remote

💵 $174k - $203k / year

⏰ Full Time

🟠 Senior

🎲 Risk

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Vaxcyte

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to prevent and treat serious bacterial infections. The company develops broad-spectrum conjugate and novel protein vaccines—using modern synthetic chemistry and a proprietary cell-free protein synthesis platform licensed from Sutro Biopharma—to create difficult-to-make protein antigens more efficiently. Its lead programs are pneumococcal conjugate vaccine candidates VAX-31 (31-valent) and VAX-24 (24-valent) in Phase 2/3 studies, with earlier-stage candidates targeting Group A Strep and Shigella; Vaxcyte focuses on reducing invasive bacterial disease burden, antibiotic resistance consequences, and related morbidity in vulnerable populations.

📋 Description

• Lead and facilitate commercial process validation and risk management activities across Vaxcyte’s end-to-end manufacturing processes. • 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. • Report to the Sr. Director of Process Validation within the Global MSAT organization and collaborate on overall validation strategy. • Provide strategic and scientific leadership for process 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. • Travel - 10-30% domestic and international travel required.

🎯 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

• Comprehensive benefits • Equity component