Scientist - Cell Culture Process Development (Pivotal & Commercial)

$130,220 - $168,520/Yr

Gilead Sciences - Oceanside, CA

Full-time - Mid Level

Oceanside, CA

Chemical Manufacturing

About the position

The Scientist, Cell Culture Process Development (Pivotal & Commercial), will be responsible for leading aspects of cell culture development including commercial process development and process characterization for multiple biologics programs during pivotal phases (phases II/III and post-launch). In addition, this role is also expected to lead projects for cell culture process technology development, platform process evolution, and to support cell culture-related regulatory documentation.

Responsibilities

• Optimize and characterize cell culture processes to supply pivotal trials and enable commercialization for monoclonal antibodies, multi-specifics, and novel modalities.
• Lead and/or support entire lifecycle of pivotal activities including process risk assessment, process characterization, preparation of all supporting documentation/reports toward BLA filing, provide support to ensure successful process performance qualifications (PPQ), and author relevant sections of BLA.
• Support technology transfer and investigation activities in partnership with the global manufacturing sciences and technologies (MSAT) group.
• Design experiments and perform hands-on cell culture operations in shake flasks, ambr15, ambr250, bench-scale bioreactors, and novel cell culture platforms.
• May provide support to pilot plant operation for up to 500 L single-use bioreactor.
• Perform statistical analyses and appropriate modeling to assess process parameter criticality, identify acceptable ranges, and contribute to integrated control strategy.
• Author and review GMP and non-GMP technical documents (reports, regulatory filings/responses, batch records, SOPs etc.), present in group/cross-functional meetings.
• Participate and work cross-functionally to achieve common goals.
• Explore, develop, and implement novel cell culture technologies to meet business needs.
• Manage direct and indirect reports and mentor junior group members while working in a flexible and agile environment.

Requirements

• Ph.D. in Chemical Engineering, Biochemistry, or related fields OR M.S. with 4+ years of relevant experience OR B.S. with 6+ years of relevant experience.

Nice-to-haves

• Strong understanding and extensive hands-on experience in cell culture process development.
• In-depth knowledge of mammalian cell culture processes including molecular biology & cell engineering concepts, media design, bioreactor scale-up, mass transfer, bioreactor control, single use and stainless bioreactor systems.
• Solid understanding and experience in statistics and data analyses.
• Experience in mammalian cell culture process development and pivotal development, process characterization and commercial support of cell culture operations from seed train to production.
• Experience in process transfer to manufacturing facilities and technical leadership in process troubleshooting.
• Well versed in FDA, EMA and ICH guidelines relating to registration, quality, and compliance concerning drug substance and experience authoring CMC sections in commercial regulatory filings (BLA, MAA) and post approval changes is a plus.
• Working knowledge in lab automation, data science, knowledge management, single-use manufacturing technology and cGMP guideline is a plus.
• Motivated self-starter with excellent interpersonal and organizational skills. Excellent verbal communication, oral presentation, and scientific writing skills.

Benefits

• Company-sponsored medical, dental, vision, and life insurance plans.
• Discretionary annual bonus.
• Discretionary stock-based long-term incentives.
• Paid time off.