Associate Director, Global Drug Substance Commercialization

October 25

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Vaxcyte

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Description

• The Associate Director for Drug Substance (DS) Commercialization of Conjugation will lead and facilitate launch readiness and commercial supply of glycoconjugate drug substances, including the polysaccharide activation, conjugation, and associated raw materials. • 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 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 Executive Director for Global DS Commercialization. • The Associate Director will collaborate on overall program strategy, with primary responsibility and accountability for the conjugate 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.

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. • Extensive experience in conjugate production processes, including polysaccharide activation, conjugation to carrier proteins, and associated purification processes across multiple operational scales. Experience with glycoconjugate vaccines is highly preferred. • 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 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.

Benefits

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