--- title: 'Associate Director, Process Validation and Risk Management at Vaxcyte' canonical: 'https://feeny.ai/job/associate-director-process-validation-and-risk-management-vaxcyte-san-carlos-tfg43s3ahnb4' type: 'job' last_seen: '2026-09-07' --- # Associate Director, Process Validation and Risk Management at Vaxcyte - **Company:** Vaxcyte - **Location:** San Carlos California, United States - **Posted:** 2026-04-03 - **Last confirmed live:** 2026-09-07 - **Apply:** https://boards.greenhouse.io/vaxcyte/jobs/5173193008?gh_jid=5173193008 ## Job description Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance. WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values: *RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered. *AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind. *LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives. *MODEL EXCELLENCE:  The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making. Summary: 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. 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. This position will report to the Sr. Director of Process Validation within the Global MSAT organization and will collaborate on overall validation strategy, with primary responsibility for process validation execution and risk management frameworks supporting commercial manufacturing. Essential Functions: Process Validation Leadership - 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. Risk Management - 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. Commercialization & Lifecycle Support - 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. Cross-functional Interface - 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. Technical Oversight - Provide guidance for validation of processes, systems, facilities, and methods within the commercial organization. - Support deviation investigations, ensuring timely resolution and sustained compliance. Regulatory - 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. Process Validation & Comparability - Provide leadership for execution of process validation and comparability activities, ensuring data integrity and compliance. Raw Material & Network Support - Provide guidance on raw material qualification strategies to ensure supply reliability. - Support validation activities across internal and external manufacturing networks. Communication & Leadership - 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. Reports to: Senior Director, Process Validation Location: San Carlos, CA or North Carolina Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component. Salary Range: $174,000 – $203,000 (SF Bay Area). Salary ranges for non-California locations may vary. ## Equal Opportunity We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status. Recruitment Fraud Notice Please be aware of fraud or scams from individuals, organizations and/or internet sites claiming to represent Vaxcyte in recruitment activities. Vaxcyte has an established recruitment process for all positions prior to issuing an offer for employment and we will never extend unsolicited employment offers or ask candidates to provide financial or sensitive personal information as part of the application process. All legitimate communication from Vaxcyte will come from an official @vaxcyte.com email address. Qualified and interested candidates should apply to current openings at [vaxcyte.com/careers](https://vaxcyte.com/careers/). ## About Vaxcyte ## Company Overview - **One-liner**: Vaxcyte is a clinical-stage biotechnology company re-engineering how vaccines are made to eliminate bacterial infections, using a cell-free protein synthesis platform to develop high-fidelity, broad-spectrum vaccines. - **Entity Type**: Public (Ticker: PCVX) - **Headquarters**: San Carlos, California, United States - **Founded**: 2013 (as SutroVax; rebranded to Vaxcyte in 2020) - **Founders**: Not publicly available (the company emerged from Sutro Biopharma’s spin-out) ## Core Business - **Primary industry**: Biotechnology / Vaccines (Infectious Disease) - **Target customers**: Global healthcare systems, public health organizations, and ultimately patients (B2B/Institutional); the company develops vaccines for both pediatric and adult populations. - **Mission or purpose**: To protect humankind from the consequences of bacterial infections, eliminating diseases like invasive pneumococcal disease, Group A Strep, and Shigella. ## Products & Services - **VAX-31 (31-valent PCV)**: A broad-spectrum pneumococcal conjugate vaccine candidate in Phase 3 for adults and Phase 2 for infants. Designed to cover over 95% of circulating IPD serotypes in U.S. adults 50+ and ~94% in infants. FDA Breakthrough Therapy designation granted. - **VAX-24 (24-valent PCV)**: A pneumococcal conjugate vaccine candidate in Phase 2 for infants, designed to cover more serotypes than any infant PCV on the market today. - **VAX-A1 (Group A Strep)**: A preclinical conjugate vaccine candidate for Group A Strep, a disease with no currently approved vaccine. Phase 1 first-in-human study (adults) underway in Australia. - **VAX-GI (Shigella)**: A novel preclinical vaccine candidate targeting Shigella, a leading cause of diarrheal disease. - **Platform Technology**: A proprietary cell-free protein synthesis platform that enables site-specific, carrier-sparing conjugation to produce precisely targeted vaccines with enhanced immunogenicity. ## Market Standing - **Valuation/Market Cap**: ~$16.7 billion (as of early July 2026) - **Key Metric**: Total funding raised (private) is not applicable; as a public company, key metrics include cash position (~$2.0 billion as of Q1 2026) and R&D investment. The company is pre-revenue. - **Notable Investors/Partners**: Major institutional investors include Baker Bros. Advisors, Fidelity, and funds managed by BlackRock. Key partnership: exclusive license agreement with Sutro Biopharma for its cell-free protein synthesis platform. - **Growth Signals**: - Up to $1 billion commitment to expanding U.S. manufacturing with a new facility in North Carolina. - VAX-31 Phase 3 program (OPUS-1, OPUS-2, OPUS-3) topline data expected Q4 2026 – H1 2027. - Headcount growth: actively hiring across 100+ roles (Analytical, Commercial, Clinical, Conjugation, Quality, Regulatory). - Recognized as a Great Place to Work and Best Workplace in BioPharma (multiple years). ## Competitive Advantages - **Broadest-spectrum PCV candidates**: VAX-31 is the broadest-spectrum pneumococcal conjugate vaccine in the clinic, targeting up to 31 serotypes. - **Differentiated platform**: Cell-free protein synthesis allows for the creation of complex, high-fidelity vaccines that can overcome bacterial defense mechanisms (e.g., capsule-switching) that limit conventional cell-based vaccines. - **Carrier-sparing technology**: Site-specific conjugation enables a higher valency (more serotypes) without compromising immunogenicity or tolerability. - **Manufacturing scale**: Significant investment in U.S.-based production capacity provides a long-term supply chain advantage and aligns with "Investing in America" initiatives. ## Strategic Focus - **Primary**: Advance VAX-31 and VAX-24 through late-stage clinical trials to secure regulatory approval and establish a new standard of care for pneumococcal disease. - **Pipeline expansion**: Advance VAX-A1 (Group A Strep) and VAX-GI (Shigella) candidates through early clinical development. - **Manufacturing**: Scale up internal manufacturing capabilities to support commercial launch and global supply. - **Commercial readiness**: Building a commercial organization (e.g., hiring a VP of U.S. Market Access & Pricing, Senior Director of Product Launch) to prepare for potential VAX-31 launch. ## Why Work Here - **Culture**: Described as a "kindness-first" mindset with a focus on audacious goals, collaboration, and mutual support. Recognized as a *Great Place to Work* and *Best Workplace in BioPharma* (Fortune). - **Work Model**: Hybrid, Remote, and Onsite options available depending on role. San Carlos HQ offers a hybrid schedule. - **Total Rewards**: 100% paid health, dental, and vision insurance; 401k matching; flexible PTO and holidays; paid parental and sick leave; equity awards (stock options & RSUs); Employee Stock Purchase Plan; lifestyle spending account; mental health and wellness resources. - **Growth & Development**: Strong emphasis on learning culture, professional advancement through coaching, and career development programs. - **Mission-driven**: Employees are directly contributing to creating vaccines that protect every child born and every adult at risk from bacterial infections globally. ## Sources 1. [vaxcyte.com](https://vaxcyte.com/) 2. [vaxcyte.com/careers](https://vaxcyte.com/careers/) 3. [vaxcyte.com/job-listings](https://vaxcyte.com/job-listings/) 4. [vaxcyte.com/culture](https://vaxcyte.com/culture/) 5. [vaxcyte.com/pipeline](https://vaxcyte.com/pipeline/) ## Other roles at Vaxcyte - [Lab Compliance Manager](https://feeny.ai/job/lab-compliance-manager-vaxcyte-san-carlos-california-znaqawfbg3r6) — San Carlos California, United States - [Staff Engineer, Process Development and Manufacturing](https://feeny.ai/job/staff-engineer-process-development-and-manufacturing-vaxcyte-san-carlos-bhp8b915gpmn) — San Carlos California, United States - [Manager, Supplier & Internal Auditor](https://feeny.ai/job/manager-supplier-internal-auditor-vaxcyte-san-carlos-california-zshqy3z2ptnp) — San Carlos California, United States - [Sample Management Specialist (Contract)](https://feeny.ai/job/sample-management-specialist-contract-vaxcyte-san-carlos-california-7dxrr7ymb1jz) — San Carlos California, United States - [Senior Manager, Immunoassay Development](https://feeny.ai/job/senior-manager-immunoassay-development-vaxcyte-san-carlos-california-w23kqwk0742d) — San Carlos California, United States - [Lab Manager, Immunoassay Development](https://feeny.ai/job/lab-manager-immunoassay-development-vaxcyte-san-carlos-california-hhgxc5d71egf) — San Carlos California, United States - [Associate Scientist II, Immunoassay Development](https://feeny.ai/job/associate-scientist-ii-immunoassay-development-vaxcyte-san-carlos-california-ems6zhtbe7aj) — San Carlos California, United States - [Scientist, Immunoassay Development](https://feeny.ai/job/scientist-immunoassay-development-vaxcyte-san-carlos-california-datkfkv3dcne) — San Carlos California, United States - [Senior Project Manager, Regulatory CMC](https://feeny.ai/job/senior-project-manager-regulatory-cmc-vaxcyte-san-carlos-california-aa6p4rh4n0rp) — San Carlos California, United States - [Senior Scientist, Immunoassay Development, Critical Reagents & Reference Materials](https://feeny.ai/job/senior-scientist-immunoassay-development-critical-reagents-reference-materials-qpw7c993hnx7) — San Carlos California, United States