Sr. Associate Scientist

United States - California - Oceanside

Process/Product Development & Operations Regular

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

* At a future date this position will relocate to the corporate HQ in Foster City, CA.

The Sr. Associate 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.

Key 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, ambr
  15, ambr
  250, 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.

Basic Qualifications:

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

Preferred Qualifications:

• 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. In-depth knowledge of industry best practices & trends.
• 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…