Director, Global Drug Substance Commercialization

🔥 12 hours ago

🇺🇸 United States – Remote

💵 $223k - $261k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 1%

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Vaxcyte

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2013

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

Healthcare • Manufacturing • Biotechnology

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to prevent and treat serious bacterial infections. The company develops broad-spectrum conjugate and novel protein vaccines—using modern synthetic chemistry and a proprietary cell-free protein synthesis platform licensed from Sutro Biopharma—to create difficult-to-make protein antigens more efficiently. Its lead programs are pneumococcal conjugate vaccine candidates VAX-31 (31-valent) and VAX-24 (24-valent) in Phase 2/3 studies, with earlier-stage candidates targeting Group A Strep and Shigella; Vaxcyte focuses on reducing invasive bacterial disease burden, antibiotic resistance consequences, and related morbidity in vulnerable populations.

📋 Description

• Lead assigned commercialization workstreams and facilitate launch readiness and commercial supply of polysaccharides used in glycoconjugate vaccines • Lead technical launch planning and execution for regulatory filings, facility readiness, and launch supplies • Coordinate cross-functional efforts across Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering • Translate commercialization strategy into execution plans and ensure key technical milestones are completed • Develop technical capabilities and support resource and staffing recommendations • Improve process understanding and robustness by monitoring, trending, and optimizing operations • Identify, communicate, and escalate technical and supply risks • Provide technical oversight for technology transfers, new technologies, internal and external manufacturing sites, and CMOs • Lead process validation and comparability activities • Review and author regulatory filings and respond to health-authority questions • Communicate process performance and the scientific and commercial rationale for polysaccharide processes to internal and external stakeholders • Lead assigned polysaccharide commercialization programs and technical workstreams • Report to the Senior Director, Global Polysaccharide Commercialization Lead • Travel 10-30%

🎯 Requirements

• Degree(s) in Chemical or Biochemical Engineering, Chemistry, Biochemistry, 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 biologic production processes, including bacterial fermentation, recovery, and purification across multiple operational scales • Experience with polysaccharides and glycoconjugate vaccines highly preferred • Leadership experience in MSAT or Process Development in supervisory and/or matrixed team roles • Deep technical knowledge applied collaboratively to establish strategic plans and achieve collective goals • Excellent organization, problem solving and strategic planning skills • Highly skilled in verbal and written communication, with ability to interact effectively with people of diverse backgrounds and perspectives • Ability to recognize needs and challenges and implement 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 • 10-30% travel required

🏖️ Benefits

• Comprehensive benefits • Equity component