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Senior Manager, Process Validation

Senior Manager, Process Validation

VaxcyteSan Carlos, CA, United States
4 days ago
Job type
  • Full-time
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 Senior Manager for End-to-End Process Validation & Technical Regulatory Liaison is accountable for leading the strategy and execution of global process validation activities across the vaccine drug substance portfolio. This role owns the planning, execution, and lifecycle management of process validation, ensuring compliance with regulatory expectations and industry best practices.

The Senior Manager provides leadership for cross-functional validation programs spanning polysaccharides, carrier proteins, conjugation, drug substance intermediates and drug product. This role is also accountable for authoring and reviewing regulatory documentation to support successful global filings, health authority interactions, and lifecycle management of commercialized products.

The position reports into the Senior Director for Global Process Validation and will collaborate on overall program strategy, with primary responsibility and accountability for validation strategy and regulatory deliverables.

Essential Functions :

  • End-to-End Process Validation

    • Lead strategy and execution of process validation, including process design, qualification, and continued verification.

  • Drive alignment with global health authority requirements (FDA, EMA, PMDA, etc.) for validation programs across multiple modalities.
  • Ensure technical robustness of validation approaches through risk assessments, process characterization, and CPV implementation.
  • Regulatory Documentation

    • Author and critically review regulatory submissions (INDs, BLAs / MAAs, supplements, responses to information requests, and briefing packages).

  • Translate complex technical data into clear, concise regulatory documentation aligned with global health authority expectations.
  • Serve as technical liaison with Regulatory Affairs to ensure timely and high-quality submissions.
  • Cross-Functional Leadership

    • Partner with MSAT, Process Development, Quality, Supply Chain, and Regulatory to ensure seamless execution of validation and regulatory deliverables.

  • Provide strategic input during technology transfers, lifecycle changes, and introduction of new manufacturing sites.
  • Support responses to health authority queries and participation in regulatory inspections.
  • Process Robustness & Lifecycle Management

    • Establish systems to monitor, trend, and improve process performance across the product lifecycle.

  • Lead technical assessments for process changes and comparability evaluations to maintain product quality and supply continuity.
  • Identify and implement best practices for sustaining process robustness and compliance.
  • Data Management

    • Acquire and gather data from manufacturing nodes throughout the supply chain to enable regulatory filings, process monitoring, and continuous improvement.

  • Support data verification for all commercial regulatory submissions.
  • Communication & Leadership

    • Communicate process validation strategy and outcomes effectively to senior leadership, regulatory bodies, and external partners.

  • Build and develop a high-performing team with expertise in validation and regulatory documentation.
  • Foster a culture of compliance, scientific rigor, and operational excellence.
  • Travel - 10-20% travel required to global manufacturing sites and regulatory interactions.

    • Requirements :

  • Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with minimum of 8+ years of relevant experience.
  • Demonstrated leadership in process validation, CPV, and regulatory submissions in a biologics or vaccine environment.
  • Broad technical knowledge across biologics processes (fermentation, purification, conjugation, formulation).
  • Proven experience authoring high-quality regulatory submissions and supporting health authority interactions.
  • Strong organizational, problem-solving, and strategic planning skills.
  • Excellent written and verbal communication skills with the ability to convey complex scientific concepts clearly.
  • Demonstrated ability to proactively identify risks and implement mitigation strategies.
  • Track record of building and mentoring teams to achieve collective goals.

    • Reports to : Senior Director, Process Validation

    Location : San Carlos, CA

    Compensation :

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

    Salary Range : $158,000 - $184,000 (SF Bay Area). Salary ranges for non-California locations may vary.

    Relocation :

    This role is not eligible for relocation assistance.

    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.

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    Validation Manager • San Carlos, CA, United States