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Scientist - Cell Culture Process Development (Pivotal & Commercial)
1010 Gilead Sciences, Inc. - Oceanside, CA
posted 2 months ago
About the position
The Scientist, Cell Culture Process Development (Pivotal & Commercial) at Gilead is responsible for leading cell culture development aspects, including commercial process development and process characterization for biologics programs during pivotal phases. This role involves optimizing cell culture processes, supporting regulatory documentation, and managing projects related to cell culture technology development. The position requires collaboration across teams to ensure successful process performance qualifications and to explore novel cell culture technologies.
Responsibilities
- Optimize and characterize cell culture processes for pivotal trials and commercialization.
- Lead and support the lifecycle of pivotal activities including process risk assessment and characterization.
- Prepare supporting documentation and reports for BLA filing.
- Support technology transfer and investigation activities with the MSAT group.
- Design experiments and perform hands-on cell culture operations in various bioreactor systems.
- Conduct statistical analyses to assess process parameter criticality and identify acceptable ranges.
- Author and review GMP and non-GMP technical documents and present in meetings.
- Explore and implement novel cell culture technologies to meet business needs.
- Manage direct and indirect reports and mentor junior group members.
Requirements
- Ph.D. in Chemical Engineering, Biochemistry, or related fields, or M.S. with 6+ years of relevant experience, or B.S. with 8+ years of relevant experience.
- Strong understanding and extensive hands-on experience in cell culture process development.
- In-depth knowledge of mammalian cell culture processes and related concepts.
- Solid understanding and experience in statistics and data analyses.
- Experience in process transfer to manufacturing facilities and technical leadership in troubleshooting.
Nice-to-haves
- Experience authoring CMC sections in commercial regulatory filings (BLA, MAA) and post-approval changes.
- Working knowledge in lab automation, data science, and single-use manufacturing technology.
Benefits
- Company-sponsored medical, dental, vision, and life insurance plans.
- Discretionary annual bonus and stock-based long-term incentives.
- Paid time off and a comprehensive benefits package.
