Director, Global Drug Substance Commercialization, Critical Raw Materials

🕒 March 18

🏄 California – Remote

🏄 California – Remote

💵 $219k - $256k / 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

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

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

• Provide strategic and scientific leadership for critical raw materials with internal and external stakeholders and ensure successful execution of launch plans and post-launch commercial activities. • Continuously improve process understanding and process robustness using staff and laboratory resources across the organization to monitor, trend, and optimize operations. • Collaboration with cross-functional teams across the network, including Regulatory, Process Development, Quality, Supply Chain, Procurement, and DS Operations, to drive the successful development and commercial launch of critical raw materials for pipeline products. • Ensure robust processes exist to support technical transfers and integration of new technologies. • Support of our internal and external manufacturing network, including materials management and data analytics. • Provide leadership for the execution of process validation and process comparability activities. Effectively communicate the scientific and commercial rationale for raw material processes to the Manufacturing organization for commercialization. • Engage in technical reviewing and authoring of regulatory filings and responding to questions received from health authorities. Effectively communicate the scientific and commercial rationale for DS processes to the Boards of Health for regulatory submissions for commercialization. • Effectively and efficiently communicate process performance to key stakeholders (internal-facing and external-facing). Connect and build strong working relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively. • Contribute as Strategy lead for assigned Critical Raw Materials and as member of the DS Commercial MSAT team, with an aim to ensure effective and efficient delivery of our life-enhancing therapies to our patients. • 10-30% travel required.

🎯 Requirements

• Degree(s) in Organic Chemistry, Biochemistry, Chemical or Biochemical Engineering, 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 scale-up, technology transfer, and relevant manufacturing process technologies /unit operations, including fermentation, recovery and purification at commercial scale. Experience with cell free protein synthesis and associated critical raw materials desired. • Experience in manufacturing equipment specification/qualification and commercial manufacturing in a GMP environment is preferred. Experience working with Contract Manufacturing Organizations is desired. • Leadership experience in MSAT or Process Development in supervisory and/or matrixed team roles. • Able to leverage deep technical knowledge in a collaborative manner to troubleshoot technical challenges, establish strategic plans, and achieve collective goals. • Excellent organization, problem solving and strategic planning skills. • Highly skilled in both verbal and written communication with the ability to interact effectively with people of diverse backgrounds and perspectives. • Proactively recognizes needs and potential challenges, and directs activities to implement effective solutions. • The ability to seek and analyze data from a variety of sources to support decisions and to align others with the organization's overall strategy. • An entrepreneurial and creative approach to developing new, innovative ideas that will stretch the organization and push the boundaries within the industry.

🏖️ Benefits

• The compensation package will be competitive and includes comprehensive benefits and an equity component.