Associate Director/Principal Scientist

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
 

The Associate Director/Principal 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 submission, provide support to ensure successful process performance qualifications (PPQ), and author relevant sections of BLA.

• Lead and/or 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 submissions/responses, batch records, SOPs etc.), present in group/cross-functional meetings.

• Participate and work cross-functionally within and outside of biologics technical development 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.

• Some travel may be required to support technology transfers and provide oversight at external manufacturing facilities.

• Adhere to department budget and all training, compliance and safety requirements.

• Remain current on trends and new technology advancements across the Biopharmaceutical industry.

• Hire, mentor and develop team members within the organization to help build and grow a world-class biologics cell culture process development organization.

Qualifications/Skills/Experience:

• Ph.D. with 5+ years OR M.S. with 8+ years OR B.S. with 10+ in a relevant scientific discipline (biology, bioengineering, chemical engineering, biochemical engineering).

• Experience leading pivotal stage cell culture process development/characterization and implementation in GMP facilities.

• Experience in building high-performing teams through strategic coaching and feedback.

• Hands-on laboratory operations experience including shake flask, high-throughput bioreactor, bench scale bioreactor, and pilot scale cultures.

• Excellent communication, technical writing, and presentation skills and aptitude for creative problem solving.

• Demonstrated ability to collaborate and influence cross-functionally.

• Experience in ce