Director, Global Drug Substance Commercialization, Polysaccharide

Vaxcyte•San Carlos, CA

6d•$223,000 - $261,000•Remote

About The Position

The Director for Drug Substance Commercialization of Polysaccharides leads assigned commercialization workstreams and facilitates launch readiness and commercial supply of polysaccharides used in glycoconjugate vaccines. The role focuses on technical launch planning and execution, coordinating cross-functional efforts for regulatory filings, facility readiness, and launch supplies. It also ensures the organization can communicate the scientific and commercial rationale for critical raw material manufacturing processes to internal stakeholders, contract manufacturing organizations (CMOs), and regulatory agencies. The Director supports on-time execution and planning for commercial lifecycle management and collaborates on overall program strategy, with primary accountability for the polysaccharide component strategy. The position reports to the Senior Director, Global Polysaccharide Commercialization. Within Manufacturing Science and Technology (MSAT), the role supports the transition of vaccine processes from Process Development to Commercial, technical launch and commercialization strategy, and continuous improvement in process robustness throughout the product lifecycle. As part of Commercial Manufacturing and Supply Chain, MSAT provides technical and process support for end-to-end commercial manufacturing, including polysaccharides, carrier proteins, and conjugation across drug substances. Activities include technology transfer support, process characterization for validation, process improvement, evaluation of new process technologies, investigation of manufacturing issues, and lifecycle process robustness improvements. The role requires 10–30% travel and is remote in the United States. Relocation assistance is not available. Compensation includes comprehensive benefits and an equity component; the stated San Francisco Bay Area salary range is $223,000–$261,000, and ranges for non-California locations may vary.

Requirements

Degree in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or a related discipline.
Minimum relevant experience of 10+ years with a Ph.D., 12+ years with an M.S./M.A., or 16+ years with a B.S./B.A.
Extensive experience in biologic production processes, including bacterial fermentation, recovery, and purification across multiple operational scales.
Leadership experience in MSAT or Process Development in supervisory and/or matrixed team roles.
Ability to apply deep technical knowledge collaboratively to establish strategic plans and achieve collective goals.
Excellent organization, problem-solving, and strategic-planning skills.
Strong verbal and written communication skills and ability to interact effectively with people of diverse backgrounds and perspectives.
Ability to anticipate needs and challenges and direct activities toward effective solutions.
Ability to seek and analyze data from varied sources to support decisions and align others with organizational strategy.
Entrepreneurial and creative approach to developing innovative ideas that stretch the organization and push industry boundaries.
Ability to travel 10–30%.

Nice To Haves

Experience with polysaccharides and glycoconjugate vaccines is highly preferred.

Responsibilities

Provide strategic and scientific leadership for polysaccharides and translate strategy into execution plans, ensuring completion of technical milestones for launch and post-launch commercial activities.
Develop technical capabilities within the polysaccharide commercialization organization and support resource and staffing recommendations.
Continuously improve process understanding and robustness by monitoring, trending, and optimizing operations using organizational staff and laboratory resources.
Coordinate cross-functional deliverables with Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering.
Identify, communicate, and escalate technical and supply risks that could affect program execution or commercial supply.
Ensure robust processes support technical transfers and integration of new technologies, providing technical oversight across internal and external manufacturing sites.
Support the internal and external manufacturing network, including materials management and data analytics, and provide technical oversight of CMOs.
Lead execution of process validation and process comparability activities.
Review and author regulatory filings and respond to health authority questions; communicate the scientific and commercial rationale for polysaccharide processes to manufacturing stakeholders and health authorities.
Communicate process performance effectively to internal and external stakeholders and build strong working relationships.
Lead assigned polysaccharide commercialization programs and technical workstreams, coordinating execution across stakeholders and contributing to Global Manufacturing Operations.
Contribute to overall program strategy while holding primary responsibility and accountability for the polysaccharide component strategy.