Director, Global Drug Substance Commercialization, Critical Raw Materials

Director, Global Drug Substance Commercialization, Critical Raw Materials

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Join our Mission to Protect Humankind! Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from bacterial diseases. Working to eradicate or treat infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning.

Summary

The Director for Drug Substance (DS) Commercialization of Critical Raw Materials will lead and facilitate launch readiness and commercial supply of critical raw materials for production of eCRM and associated components for glycoconjugate vaccines. This role focuses on technical launch planning and execution by bringing best‑practices and coordinating cross‑functional efforts for regulatory filings, facility readiness, launch supplies and post‑launch process robustness initiatives.

Essential Functions

• DS Commercialization – Provide strategic and scientific leadership for critical raw materials with internal and external stakeholders, ensuring successful execution of launch plans and post‑launch commercial activities.

• Process robustness – Continuously improve process understanding and robustness using staff and laboratory resources across the organization to monitor, trend, and optimize operations.

• Interface – Collaborate with cross‑functional teams across Regulatory, Process Development, Quality, Supply Chain, Procurement, and DS Operations.

• Tech‑transfer new technologies – Ensure robust processes exist to support technical transfers and integration of new technologies.

• Support technical services – Support internal and external manufacturing network, including materials management and data analytics.

• Process validation and comparability – Provide leadership for the execution of process validation and comparability activities.

• Regulatory – Engage in technical reviewing and authoring of regulatory filings and respond to questions from health authorities.

• Communicate – Effectively communicate process performance to key stakeholders and build strong working relationships.

• Leadership – Contribute as strategy lead for assigned Critical Raw Materials and as member of DS Commercial MSAT team.

• Travel – 10‑30% travel required.

Requirements

• Degree(s) in Organic Chemistry, Biochemistry, Chemical or Biochemical Engineering, or related; minimum of 10+ years experience (Ph.D.), 12+ (M.S./M.A.), or 16+ (B.S./B.A.).

• Extensive experience in scale‑up, technology transfer, and manufacturing process technologies/unit operations.

• Experience in manufacturing equipment specification/qualification and commercial manufacturing in a GMP environment preferred.

• Leadership experience in MSAT or Process Development supervisory 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 verbal and written communication with ability to interact effectively with diverse backgrounds.

• Proactively recognizes needs and potential challenges, and directs activities to implement effective solutions.

• Analytical skills to seek and analyze data from various sources to support decisions and align others.

• An entrepreneurial and creative approach to developing new, innovative ideas that stretch the organization.

Reports to

Senior Director, Global Drug Substance Commercialization Lead, Protein

Location

San Carlos, CA

Compensation

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

Salary Range

$219,000 - $256,000 (SF Bay Area). Salary ranges for non‑California locations may vary.

Relocation

This role is not eligible for relocation assistance.

Equal Opportunity Statement

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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