Protein Upstream Development Manager
2 weeks ago
Vaxcyte is a pioneering vaccine innovation company dedicated to protecting humankind from the consequences of bacterial diseases. We're seeking an experienced and driven technical leader to join our Product Development organization as a Sr. Manager of Upstream Development within the Protein Development and Manufacturing group.
About the RoleThis is an exciting opportunity to join a talented team with a mission to advance drug substances and intermediates derived from cell-free synthesis platforms through clinical stage and commercial launch. As a Sr. Manager of Upstream Development, you will be accountable for technical execution oversight of process characterization related to critical reagents for our cell-free synthesis platform.
Key Responsibilities- 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.
- 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.
Vaxcyte offers a competitive compensation package, comprehensive benefits, and an equity component. We are an equal opportunity employer and welcome applications from diverse candidates.
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San Carlos, California, United States Vaxcyte Full timeAbout VaxcyteVaxcyte is a pioneering vaccine innovation company dedicated to protecting humankind from the consequences of bacterial diseases. Our mission is to eradicate or treat bacterial infections that have serious and costly health consequences when left unchecked.Job SummaryWe are seeking an experienced and driven technical leader to join our Product...
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