Vaxcyte
Associate Director, Commercial MSAT, Polysaccharide
Vaxcyte, San Carlos, California, United States, 94071
Associate Director, Commercial MSAT, Polysaccharide
Join our Mission to Protect Humankind! Vaxcyte is a clinical‑stage vaccine innovation company engineering high‑fidelity vaccines to protect humankind from bacterial diseases such as invasive pneumococcal disease, Group A Strep, and Shigella. Our path to success is clear and well‑defined, and Vaxcyte is set up to go the distance.
Summary The Associate Director, Commercial MSAT for Polysaccharides will lead and facilitate launch readiness and commercial supply of the polysaccharides used in glycoconjugate vaccines. 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. The incumbent will provide leadership to ensure the organization is equipped to effectively communicate the scientific and commercial rationale for critical raw material manufacturing processes to stakeholders, CMOs, and regulatory agencies. They will work to ensure on‑time execution and appropriate planning for commercial lifecycle management. The associate reports to the Director, Commercial MSAT for Polysaccharides and collaborates on overall program strategy, with primary responsibility for the polysaccharide drug substance intermediate.
Essential Functions
DS Commercialization – provide strategic and scientific leadership for polysaccharides, ensuring successful execution of launch plans and post‑launch commercial activities.
Organization – build a strong, highly‑skilled team for the global network, focusing on polysaccharide manufacturing processes and supporting resourcing recommendations.
Process robustness – continuously improve process understanding and robustness using staff and laboratory resources to monitor, trend, and optimize operations.
Interface – collaborate with cross‑functional teams across the network (Regulatory, CMC, Quality, Supply Chain, Procurement, Process Engineering) to drive successful development and commercial launch of carrier proteins for pipeline products.
Tech‑transfer new technologies – ensure robust processes exist to support technical transfers and integration of new technologies.
Support technical services – support internal and external manufacturing network, including materials management and data analytics.
Process validation and comparability – lead execution of process validation and comparability activities, communicating scientific and commercial rationale to the Manufacturing organization.
Regulatory – engage in technical reviewing and authoring of regulatory filings, responding to questions from health authorities, communicating rationale to Boards of Health.
Communicate – effectively and efficiently communicate process performance to key stakeholders, building strong working relationships with others.
Leadership – contribute as a member of the polysaccharide governance teams, ensuring efficient delivery of life‑enhancing therapies.
Travel – 10–30% travel required.
Requirements
Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with 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.
Extensive experience in biologic production processes, including bacterial fermentation, recovery, and purification across multiple operational scales; experience with polysaccharides and glycoconjugate vaccines highly preferred.
Leadership experience in MSAT or Process Development in supervisory and/or matrixed team roles.
Ability to leverage deep technical knowledge in a collaborative manner to establish strategic plans and achieve collective goals.
Excellent organization, problem solving, and strategic planning skills.
Highly skilled in verbal and written communication, interacting effectively with diverse backgrounds and perspectives.
Proactively recognizes needs and potential challenges, directing activities to implement effective solutions.
Ability to seek and analyze data from a variety of sources to support decisions and align others with the organization’s overall strategy.
Entrepreneurial and creative approach to developing new, innovative ideas that stretch the organization and push industry boundaries.
Reports to Director, Commercial MSAT, Polysaccharides
Location San Carlos, CA or North Carolina
Compensation The compensation package is 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.
EEO Statement 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 Associate Director, Commercial MSAT for Polysaccharides will lead and facilitate launch readiness and commercial supply of the polysaccharides used in glycoconjugate vaccines. 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. The incumbent will provide leadership to ensure the organization is equipped to effectively communicate the scientific and commercial rationale for critical raw material manufacturing processes to stakeholders, CMOs, and regulatory agencies. They will work to ensure on‑time execution and appropriate planning for commercial lifecycle management. The associate reports to the Director, Commercial MSAT for Polysaccharides and collaborates on overall program strategy, with primary responsibility for the polysaccharide drug substance intermediate.
Essential Functions
DS Commercialization – provide strategic and scientific leadership for polysaccharides, ensuring successful execution of launch plans and post‑launch commercial activities.
Organization – build a strong, highly‑skilled team for the global network, focusing on polysaccharide manufacturing processes and supporting resourcing recommendations.
Process robustness – continuously improve process understanding and robustness using staff and laboratory resources to monitor, trend, and optimize operations.
Interface – collaborate with cross‑functional teams across the network (Regulatory, CMC, Quality, Supply Chain, Procurement, Process Engineering) to drive successful development and commercial launch of carrier proteins for pipeline products.
Tech‑transfer new technologies – ensure robust processes exist to support technical transfers and integration of new technologies.
Support technical services – support internal and external manufacturing network, including materials management and data analytics.
Process validation and comparability – lead execution of process validation and comparability activities, communicating scientific and commercial rationale to the Manufacturing organization.
Regulatory – engage in technical reviewing and authoring of regulatory filings, responding to questions from health authorities, communicating rationale to Boards of Health.
Communicate – effectively and efficiently communicate process performance to key stakeholders, building strong working relationships with others.
Leadership – contribute as a member of the polysaccharide governance teams, ensuring efficient delivery of life‑enhancing therapies.
Travel – 10–30% travel required.
Requirements
Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, or related discipline with 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.
Extensive experience in biologic production processes, including bacterial fermentation, recovery, and purification across multiple operational scales; experience with polysaccharides and glycoconjugate vaccines highly preferred.
Leadership experience in MSAT or Process Development in supervisory and/or matrixed team roles.
Ability to leverage deep technical knowledge in a collaborative manner to establish strategic plans and achieve collective goals.
Excellent organization, problem solving, and strategic planning skills.
Highly skilled in verbal and written communication, interacting effectively with diverse backgrounds and perspectives.
Proactively recognizes needs and potential challenges, directing activities to implement effective solutions.
Ability to seek and analyze data from a variety of sources to support decisions and align others with the organization’s overall strategy.
Entrepreneurial and creative approach to developing new, innovative ideas that stretch the organization and push industry boundaries.
Reports to Director, Commercial MSAT, Polysaccharides
Location San Carlos, CA or North Carolina
Compensation The compensation package is 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.
EEO Statement 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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