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Job Description
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.
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.
Lead and/or support technology transfer, person-in-plant, 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.
Provide support to pilot plant operation for up to 500 L.
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.
May manage direct and indirect reports and mentor junior group members while working in a flexible and agile environment.
Basic Qualifications
Bachelor's Degree and Six Years' Experience
OR
Masters' Degree and Four Years' Experience
OR
PhD/PharmD
Preferred Qualifications
Ph.D. with 0-2 years of relevant experience
Strong understanding and 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. Working knowledge of industry best practices & trends.
Hands-on laboratory operations experience including shake flasks, high-throughput bioreactors, bench scale bioreactors, or pilot scale cultures.
Solid understanding and experience in statistics and data analyses.
Basic knowledge of FDA, EMA and ICH guidelines relating to registration,…