Vaxcyte, Inc
Senior Manager, Process Validation
Vaxcyte, Inc, San Carlos, California, United States, 94071
Senior Manager for End-to-End Process Validation & Technical Regulatory Liaison
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.
Provides leadership for cross-functional validation programs spanning polysaccharides, carrier proteins, conjugation, drug substance intermediates and drug product. Authors and reviews regulatory documentation to support successful global filings, health authority interactions, and lifecycle management of commercialized products. Reports into the Senior Director for Global Process Validation.
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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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.
Provides leadership for cross-functional validation programs spanning polysaccharides, carrier proteins, conjugation, drug substance intermediates and drug product. Authors and reviews regulatory documentation to support successful global filings, health authority interactions, and lifecycle management of commercialized products. Reports into the Senior Director for Global Process Validation.
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.
#J-18808-Ljbffr