Director, Global Drug Substance Commercialization

October 11

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Vaxcyte

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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. • The Director for Drug Substance (DS) Commercialization will lead and facilitate launch readiness and commercial supply of critical raw materials for 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. • Provides leadership to ensure effective communication of scientific and commercial rationale for critical raw material manufacturing processes to internal stakeholders and regulatory agencies. • This position will collaborate with the Sr. Director for Global DS Commercialization, Protein, and has primary responsibility for the critical raw material strategy. • MSAT is responsible for transitioning the vaccine process from Development to Commercial, ensuring best possible patient outcomes while creating value for the enterprise.

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 chemical synthesis, scale-up, technology transfer, and relevant manufacturing process technologies /unit operations, including multi-step synthesis, route selection, chromatography, crystallization, solid form, etc. • Experience in small molecule manufacturing equipment specification/qualification and commercial manufacturing in a GMP environment is preferred. Experience working with Contract Manufacturing Organizations is desired. • Technical knowledge of bacterial fermentation, recovery, and purification at commercial scale 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.