Director, Global Drug Substance Commercialization, Conjugation

🕒 September 17

🏄 California, North Carolina – Remote

🏄 California – Remote 🌲 North Carolina – Remote

💵 $210k - $245k / year

⏰ Full Time

🔴 Lead

👔 Director

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 and facilitate launch readiness and commercial supply of glycoconjugate drug substances, including polysaccharide activation, conjugation, and associated raw materials • Lead technical launch planning and execution for regulatory filings, facility readiness, and launch supplies • Ensure effective communication of scientific and commercial rationale for critical raw material manufacturing processes to internal stakeholders, CMOs, and regulatory agencies • Plan and execute commercial lifecycle management activities • Provide strategic and scientific leadership for polysaccharide activation and conjugation processes • Build and develop a highly skilled global conjugation manufacturing team and support staffing recommendations • Continuously improve process understanding and robustness by monitoring, trending, and optimizing operations • Collaborate with Regulatory, CMC, Quality, Supply Chain, Procurement, and Process Engineering teams • Support technical transfers and integration of new technologies • Support internal and external manufacturing networks, materials management, and data analytics • Lead process validation and comparability activities • Review and author regulatory filings and respond to health authority questions • Communicate process performance to internal and external stakeholders • Serve as DS Commercialization lead for Conjugation within Global Manufacturing Operations

🎯 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 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 • 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 • 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 various 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 • Remote work arrangement