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. 

Summary:

The Director for Drug Substance (DS) Commercialization of Critical Raw Materials will lead and facilitate launch readiness and commercial supply of critical raw materials for production of eCRM and associated components for glycoconjugate vaccines. In this role the incumbent will serve as the technical lead and SME on biologic raw material processes . This role focuses on technical launch planning and execution by bringing best-practices and coordinating cross-functional efforts for regulatory filings, facility readiness, launch supplies and post-launch process robustness initiatives.

This role also provides leadership to ensure that the organization is equipped to effectively communicate the scientific and commercial rationale for critical raw material manufacturing processes to internal stakeholders, relevant CMOs, and to regulatory agencies. The incumbent will work with the organization to ensure on-time execution and appropriate planning for commercial lifecycle management.

This position will be reporting into the Sr. Director for Global DS Commercialization, Protein. The Director will collaborate on overall program strategy, with primary responsibility and accountability for assigned critical raw material strategy, subject matter expertise and associated regulatory filings and supporting studies.

Global Manufacturing Science and Technology (GMSAT) is responsible for successfully and seamlessly transitioning the vaccine process from Process Development to Commercial, developing and executing technical launch and commercialization strategy, continuously improving process robustness through to end of lifecycle, and ensuring best possible patient outcomes while creating value for the enterprise. As part of the Technical Operations organization, GMSAT will lead the technical and process support for end-to-end commercial manufacturing, including Polysaccharides, Carrier Proteins, and Conjugation across all Drug Substances (DS). The range of activities will include technology transfer support, process characterization experiments in support of validation, process improvement, evaluation of novel process technologies, investigation of process related manufacturing issues, ensuring continuous improvement in process robustness throughout the product life cycle, etc. 

Essential Functions:

• DS Commercialization – Provide strategic and scientific leadership for critical raw materials with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities.
• Process robustness – Continuously improve process understanding and process robustness using staff and laboratory resources across the organization to monitor, trend, and optimize operations.
• Interface - Collaboration with cross-functional teams across the network, including Regulatory, Process Development, Quality, Supply Chain, Procurement, and DS Operations, to drive the successful development and commercial launch of critical raw materials for pipeline products.
• Tech-transfer new technologies - Ensure robust processes exist to support technical transfers and integration of new technologies.
• Support technical services - Support of our internal and external manufacturing network, including materials management and data analytics.
• Process validation and comparability - Provide leadership for the execution of process validation and process comparability activities. Effectively communicate the scientific and commercial rationale for raw material processes to the Manufacturing organization for commercialization
• Regulatory - Engage In technical reviewing and authoring of regulatory filings and responding to questions received from health authorities. Effectively communicate the scientific and commercial rationale for DS processes to the Boards of Health for regulatory submissions for commercialization.
• Communicate - Effectively and efficiently communicate process performance to key stakeholders (internal-facing and external-facing). Connect and build strong working relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
• Leadership - Contribute as Strategy lead for assigned Critical Raw Materials and as member of the DS Commercial MSAT team, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients.
• Travel - 10-30% travel required.

Requirements: 

• Degree(s) in Organic Chemistry, Biochemistry, Chemical or Biochemical Engineering, or related discipline with a minimum of 10+ years of relevant experience for Ph.D., 12+ years for M.S./M.A., or 16+ years for B.S./B.A.
• Extensive experience in scale-up, technology transfer, and relevant manufacturing process technologies /unit operations, including fermentation, recovery and purification at commercial scale. Experience with cell free protein synthesis and associated critical raw materials desired.
• Experience in manufacturing equipment specification/qualification and commercial manufacturing in a GMP environment is preferred. Experience working with Contract Manufacturing Organizations is desired.
• Leadership experience in MSAT or Process Development in supervisory and/or matrixed team roles.
• Able to leverage deep technical knowledge in a collaborative manner to troubleshoot technical challenges, establish strategic plans, and achieve collective goals.
• Excellent organization, problem solving and strategic planning skills.
• Highly skilled in both verbal and written communication with the ability to interact effectively with people of diverse backgrounds and perspectives.
• Proactively recognizes needs and potential challenges, and directs activities to implement effective solutions.
• The ability to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy.
• An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.

Summary:

The Senior Manager for Drug Substance (DS) Commercialization has the responsibility for launch readiness and commercial supply of the conjugate drug substance. The conjugate product strategy will transition from the Process Development organization to Manufacturing Science and Technology (MSAT) during late-stage product development.  This role focuses on technical launch planning and execution by bringing best-practices and coordinating cross-functional efforts for regulatory filings, facility readiness, and launch supplies.

This role also provides leadership to ensure that the organization is equipped to effectively communicate the scientific and commercial rationale for conjugation process to internal stakeholders, relevant CMOs, and to regulatory agencies. The incumbent will be highly skilled in written communication, especially in regard to authoring Health Authority submissions (IND/BLA). The role will also require the ability to interact effectively with people of diverse backgrounds and perspectives. The incumbent will also work with the organization to ensure on-time execution and appropriate planning for commercial lifecycle management.

This position will be reporting into the Director for Global DS Commercialization, Conjugation. The Sr. Manager will collaborate on overall program strategy, with primary responsibility and accountability for the drug substance strategy. 

Manufacturing Science and Technology (MSAT) is responsible for successfully and seamlessly transitioning the vaccine process from Process Development to Commercial, developing and executing technical launch and commercialization strategy, continuously improving process robustness through to end of lifecycle, and ensuring best possible patient outcomes while creating value for the enterprise. As part of the Commercial Manufacturing and Supply Chain organization, MSAT will lead the technical and process support for end-to-end commercial manufacturing, including Polysaccharides, Carrier Proteins, Conjugation across all Drug Substances (DS). The range of activities will include DS technology transfer support, process characterization experiments in support of validation, process improvement, evaluation of novel process technologies, and investigation of process related manufacturing issues, ensuring continuous improvement in process robustness throughout the product life cycle etc. 

Essential Functions:

• DS Commercialization – Provide strategic and scientific leadership for polysaccharide to protein conjugation with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities.
• Organization – Build a strong and highly-skilled team for the global network with special focus on manufacturing processes. Support resourcing recommendations on staffing requirements to meet organizational goals.
• Process robustness – Continuously improve process understanding and process robustness by putting systems in place to monitor, trend, and optimize operations.
• Interface - Collaboration with cross-functional teams across the network, including Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering, to drive the successful development and commercial launch of the conjugate drug substance. Provides technical representation into initial technology transfer, product launch, product lifecycle, to the end of life/product retirement and for defining/developing the next generation of production technologies.
• Tech-transfer new technologies - Ensure robust processes exist to support technical transfers and integration of new technologies.
• Support technical services - Support of our internal and external manufacturing network, including materials management and data analytics.
• Process validation and comparability - Provide support for the execution of process validation and process comparability activities.
• Regulatory - Engage In technical reviewing and authoring of regulatory filings and responding to questions received from health authorities. Effectively communicate the scientific and commercial rationale for DS processes to the Boards of Health for regulatory submissions for commercialization.
• Communicate - Effectively and efficiently communicate process performance to key stakeholders (internal-facing and external-facing). Connect and build strong working relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.
• Executing for Results - Set clear and challenging goals and take accountability for driving results. Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.
• Leadership - Contribute with the DS Commercialization lead and as member of the Global Manufacturing Operations, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients. Delegate effectively, celebrate diversity within the team, and manage team performance with a strong focus on colleague development.
• Travel - 10-30% travel required.

Requirements: 

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with a minimum of 5+ years of relevant experience for Ph.D., 8+ years for M.S./M.A., or 12+ years for B.S./B.A.
• Experience in development, tech transfer, scale-up or production of polysaccharide/protein conjugate vaccines
• Experience in MSAT or Process Development in supervisory and/or matrixed team roles.
• Able to leverage deep technical knowledge in a collaborative manner to achieve collective goals.
• Excellent organization, problem solving and strategic planning skills.
• Highly skilled in both verbal and written communication, especially in regards to authoring Health Authority submissions (IND/BLA) with the ability to interact effectively with people of diverse backgrounds and perspectives.
• Proactively recognizes needs and potential challenges, and independently identifies and implements effective steps and solutions.
• The ability to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy.
• An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.