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Director of Global Drug Substance Commercialization for Critical Raw Materials

Vaxcyte, Inc.San Carlos, California, United States
On-site Full-time $219K/yr - $256K/yr

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Experience Level

Senior Level Manager

Qualifications

Proven experience in drug substance commercialization and supply chain management, particularly in biologics. Strong technical knowledge of raw material processes used in vaccine production. Exceptional project management skills with a track record of successful launch planning and execution. Excellent communication skills for engaging with diverse stakeholders, including regulatory agencies. Ability to work collaboratively across multiple functions to drive project success. Advanced degree in a relevant scientific or engineering discipline preferred.

About the job

Join Our Mission to Protect Humanity!

Vaxcyte is a pioneering clinical-stage vaccine innovation firm dedicated to engineering high-fidelity vaccines designed to safeguard humanity against the dire and costly consequences of bacterial diseases. Our mission extends to eradicating or treating bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella—this is merely the start of our journey. With a clear and well-defined path to success, Vaxcyte is poised to make a significant impact.
 
Our approach is as crucial as the outcomes! Our collaborative efforts are anchored by four fundamental core values:
 
*RETHINK CONVENTION: We infuse creativity and intellectual diversity into every aspect of our work, continuously innovating the delivery of vaccines.
 
*AIM HIGH: We passionately pursue our ambitious goal to develop the most complex biologics ever attempted for the protection of humankind.
 
*LEAD WITH HEART: At Vaxcyte, everyone is a leader, embracing a kindness-first, inclusive approach that fosters collaboration and robust debate to advance our business objectives.
 
*MODEL EXCELLENCE: The magnitude of our challenges necessitates a collective commitment to integrity, accountability, equality, and transparency in our communications and decision-making.

Position Overview:

The Director of Drug Substance (DS) Commercialization for Critical Raw Materials will spearhead the launch readiness and commercial supply of essential raw materials for the production of engineered Critical Raw Materials (eCRM) and related components for glycoconjugate vaccines. This role encompasses serving as the technical lead and Subject Matter Expert (SME) on biologic raw material processes. The primary focus is on technical launch planning and execution, utilizing best practices while coordinating cross-functional efforts for regulatory submissions, facility readiness, launch supplies, and post-launch process robustness initiatives.

This position also involves providing leadership to ensure effective communication regarding the scientific and commercial rationale behind critical raw material manufacturing processes to internal stakeholders, Contract Manufacturing Organizations (CMOs), and regulatory agencies. The incumbent will collaborate with the organization to guarantee timely execution and meticulous planning for commercial lifecycle management.

This position reports to the Senior Director of Global DS Commercialization, Protein.

About Vaxcyte, Inc.

Vaxcyte, Inc. is at the forefront of vaccine innovation, focused on developing high-fidelity vaccines to combat bacterial diseases. Our mission is not just to treat but to eradicate serious health threats posed by bacterial infections, ensuring a healthier future for all. Join us in our quest to make a lasting impact in global health.

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