Director, Global Drug Substance Commercialization, Polysaccharide

Vaxcyte•San Carlos, CA

7d•$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, and supports timely planning and execution of commercial lifecycle management. Reporting to the Senior Director for Global Polysaccharide Commercialization, the Director collaborates on overall program strategy and is primarily accountable for the polysaccharide component strategy. 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 process robustness throughout the product lifecycle. MSAT provides technical and process support for end-to-end commercial manufacturing across polysaccharides, carrier proteins, and conjugation, including technology transfer, process characterization for validation, process improvement, evaluation of new technologies, and investigation of manufacturing issues. The position is remote in the United States and requires 10–30% travel. The listed salary range is $223,000–$261,000 for the San Francisco Bay Area; ranges for non-California locations may vary. The compensation package includes comprehensive benefits and an equity component. Relocation assistance is not available.

Requirements

Degree in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, or a related discipline.
Minimum relevant experience: 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.
Highly skilled verbal and written communication, with the ability to interact effectively with people of diverse backgrounds and perspectives.
Ability to proactively recognize needs and potential challenges and direct activities to implement effective solutions.
Ability to seek and analyze data from a variety of 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.

Nice To Haves

Experience with polysaccharides and glycoconjugate vaccines is highly preferred.

Responsibilities

Provide strategic and scientific leadership for polysaccharides with internal and external stakeholders, translating strategy into execution plans and ensuring completion of key technical milestones for launch and post-launch commercial activities.
Develop technical capabilities within the polysaccharide commercialization organization and support resource and staffing recommendations to achieve program and organizational objectives.
Continuously improve process understanding and robustness by using organizational staff and laboratory resources to monitor, trend, and optimize operations.
Coordinate cross-functional deliverables across Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering for development and commercial launch of pipeline polysaccharides.
Identify, communicate, and escalate technical and supply risks that may 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 to support reliable manufacturing and commercial supply.
Lead process validation and process comparability activities and communicate the scientific and commercial rationale for polysaccharide processes to the Manufacturing organization.
Review and author regulatory filings and respond to health authority questions; communicate the scientific and commercial rationale for polysaccharide processes to Boards of Health for commercialization submissions.
Communicate process performance effectively to internal and external stakeholders, building strong working relationships and communicating clearly and persuasively.
Lead assigned polysaccharide commercialization programs and technical workstreams, coordinate execution across stakeholders, and contribute to the Global Manufacturing Operations organization.
Travel 10–30%.