Sr Scientist, Process Development
Gilead Sciences · Foster City, CA
CMCFull-time$169k–$219kCompany career page
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What they're looking for
- Bachelor's degree with 8+ years experience, or Master's with 6+ years, or PhD/PharmD
- Experience leading pivotal-stage cell culture process development in GMP facilities
- Hands-on bioreactor operations across multiple scales from shake flask to pilot plant
- Strong technical writing and cross-functional collaboration skills
- Experience with design-of-experiments, statistics, and data analysis tools
- Team leadership and talent development capabilities
- Knowledge of cell culture media development and upstream process modeling preferred
What you'll be doing
- Optimize and characterize cell culture processes for monoclonal antibodies and novel modalities supporting pivotal trials and commercialization
- Lead process risk assessment, characterization studies, and regulatory documentation preparation for BLA submissions
- Design and execute cell culture experiments across multiple bioreactor platforms and scales
- Hire, mentor, and develop direct reports to build high-performing cell culture process development team
- Conduct statistical analyses and modeling to establish process parameter criticality and control strategies
Privacy & handoff
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