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Director of Device Development and Commercialization

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

Qualifications:A degree in a relevant scientific field (PhD preferred). Extensive experience in drug product development, particularly in the vaccine industry. Proven leadership skills with experience managing cross-functional teams. Strong understanding of regulatory requirements and submission processes. Excellent communication and problem-solving abilities.

About the job

Join Our Mission to Safeguard Humanity!

At Vaxcyte, we are pioneering innovative vaccine solutions designed to protect humanity from the severe and costly impacts of bacterial diseases. Our commitment extends to addressing critical infections such as invasive pneumococcal disease, Group A Strep, and Shigella. With a clear and defined pathway ahead, Vaxcyte is poised for success in the fight against bacterial infections.
 
Our Approach: We Value Both What We Do and How We Do It! Our collaborative efforts are driven by four core values:
 
*RETHINK CONVENTION: We inject creativity and diverse intellect into every aspect of our work, continually innovating the vaccine delivery process.
 
*AIM HIGH: We embrace ambitious goals, boldly tackling the complexities of biologics to safeguard human health.
 
*LEAD WITH HEART: Vaxcyte fosters a culture of kindness and inclusivity, encouraging robust discussions that propel our objectives.
 
*MODEL EXCELLENCE: Our challenges require a unified commitment to integrity, accountability, and clear communication.

Position Overview:

The Director of Device Development and Commercialization will oversee the VAX-31 drug product, an intricate biological entity consisting of 31 Drug Substances formulated as an adjuvanted suspension Drug Product. The role demands meticulous attention to the development of a pre-filled syringe (PFS) combination product for both clinical and commercial applications. We seek an enthusiastic and skilled professional to lead our Drug Product Development Team through essential development and regulatory milestones, ensuring our product's successful launch and distribution.

The VAX-31DP presents unique challenges in production, handling, and testing due to its suspension system. The director will navigate these complexities by managing their team and collaborating within a matrix structure across the broader Drug Product and commercial organization. Furthermore, it is essential to comprehend, manage, and effectively communicate these challenges to regulatory bodies through compelling submissions. Experience in the vaccine sector, particularly with adjuvants, is highly desirable.

About Vaxcyte, Inc.

Vaxcyte, Inc. is a clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines aimed at protecting humanity from bacterial diseases. Through our commitment to scientific excellence and innovation, we strive to eradicate severe infections and improve global health outcomes.

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