Sr. Manager, Protein Upstream Development

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Job description

Join our Mission to Protect Humankind!

Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:

RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.

AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.

LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.

MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.

Summary:

Vaxcyte is looking for an experienced and driven technical leader to join Vaxcyte's Product Development organization as a Sr Manager of Upstream Development within the Protein Development and Manufacturing group. This is an exciting opportunity to join an outstanding team with a mission to advance drug substances and intermediates derived from cell free synthesis platform through clinical stage and commercial launch. Specifically, this candidate would be accountable for technical execution oversight of process characterization related to critical reagents for our cell free synthesis platform.

The successful candidate will have the following skills and qualities:

An experienced and skilled scientist with extensive expertise in late-stage upstream process development.
A strong technical leader experienced in providing mentoring and training of junior staff members.
An exceptional team player who works seamlessly with others, speaks up, and remains focused on achieving the best results to attain company goals.
A strong sense of ownership and accountability; commitment to Vaxcyte's mission of protecting humankind.
Essential Functions:

• Drive Quality by Design (QbD) based process development by conducting process risk assessments, analyzing critical process parameters (CPPs) to characterize microbial fermentation and primary recovery unit operations.
• Lead the planning and technical execution of process characterization strategy suitable for cell free critical reagents.
• Responsible for managing multiple projects and collaborating with Manufacturing Science and Technology (MSAT), Analytical Development/Quality Control (AD/QC), Quality Assurance (QA), Project Management (PM) and the supply chain teams to ensure project timelines and deliverables are met efficiently.
• Mentor and lead junior team members to accomplish project goals.
• Collaborate with clinical MSAT to implement scale-up/down models to support technology transfer and manufacturing activities.
• Represent fermentation upstream development at CMC meetings and with external partners.

Requirements:

• PhD in Chemical Engineering or Chemistry/Biochemistry with 5+ years of relevant Pharma/Biotech industry experience, or MS in Chemical Engineering or Chemistry/ Biochemistry with 8+ years of relevant Pharma/Biotech industry experience.
• Late-stage process development experience is strongly desirable.
• Strong technical expertise with microbial fermentation, primary recovery and bioprocess optimization.
• In-depth understanding of fermentation principles. Familiarity with various fermentation techniques, bioreactor configurations and process analytics/control systems.
• Sound understanding in basic protein biochemistry.
• Experience in primary recovery unit operations such as homogenization, centrifugation, and depth filtration.
• Experience with cell-free upstream technology a plus but not required.
• Adept in the application of Design of Experiments (DoE) methodology.
• Proven technical leadership skills including strong project management skills, with the ability to manage multiple projects simultaneously.
• Familiarity with cGMP requirements.
• Clear and compelling (written and oral) communication skills.
• Proven ability to collaborate with cross-functional teams.

Reports to: Director, Upstream Development and Manufacturing

Location: San Carlos, CA

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

Salary Range: $180,000 - $187,000

Vaxcyte, Inc.
825 Industrial Road, Suite 300
San Carlos, CA 94070

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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