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. 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, 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.
Reports to: Executive Director, Global DS Commercialization Lead
Location: San Carlos, CA, Raleigh-Durham, NC, or Remote
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $190,000 – $197,000 (SF Bay Area). Salary ranges for non-California locations may vary.
Vaxcyte, Inc.
825 Industrial Road, Suite 300
San Carlos, CA 94070
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.