Associate Director / Principal Scientist

Associate Director / Principal Scientist

United States - California - Foster City Process / Product Development & Operations Regular

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

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