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Senior Manager, Global Drug Substance Commercialization, Conjugation

VaxcyteSan Carlos, California, United States
On-site Full-time $165K/yr - $193K/yr

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Experience Level

Senior Level Manager

Qualifications

Proven experience in drug substance commercialization and product launch. Strong understanding of regulatory requirements and experience with Health Authority submissions. Exceptional written and verbal communication skills. Diverse background in cross-functional team leadership. Ability to navigate complex challenges with innovative solutions.

About the job

Join Our Mission to Safeguard Humanity!

Vaxcyte is at the forefront of vaccine innovation, dedicated to developing high-fidelity vaccines aimed at protecting humanity from serious bacterial diseases. Our commitment to eradicating or effectively treating infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. With a clear and well-defined path ahead, Vaxcyte is positioned for long-term success.
 
Our approach is defined by our core values:
 
*RETHINK CONVENTION: We embrace creative and intellectual diversity to innovate and continuously improve vaccine delivery.
 
*AIM HIGH: We pursue our collective audacious goal of developing the most complex biologics to protect humanity.
 
*LEAD WITH HEART: At Vaxcyte, we lead with kindness and inclusivity, fostering collaborative discussions that propel our business objectives.
 
*MODEL EXCELLENCE: Our significant challenges demand a shared commitment to integrity, accountability, equality, and clear communication.

Role Summary:

The Senior Manager for Drug Substance (DS) Commercialization will oversee the launch readiness and commercial supply of the conjugate drug substance. This role will facilitate the transition of the conjugate product strategy from the Process Development team to Manufacturing Science and Technology (MSAT) during the late stages of product development. Key responsibilities include technical launch planning and execution, implementing best practices, and coordinating cross-functional efforts for regulatory submissions, facility preparations, and launch materials.

The successful candidate will provide leadership to ensure effective communication of the scientific and commercial rationale for the conjugation process to internal stakeholders, relevant Contract Manufacturing Organizations (CMOs), and regulatory bodies. Exceptional written communication skills are essential, particularly in authoring submissions to Health Authorities (IND/BLA). The ability to collaborate with individuals from diverse backgrounds and perspectives is crucial for success in this role.

About Vaxcyte

At Vaxcyte, we are committed to pioneering vaccine technologies that address the global health challenges posed by bacterial diseases. Our team is driven by a shared mission to innovate and deliver solutions that safeguard public health.

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