Details: Serves as a process technical subject matter expert to small/large scale cell culture and harvest unit operations for the development and pilot manufacture of biopharmaceuticals. The successful candidate will be key contributor to a dynamic and highly technical team of engineers and scientists by setting appropriate objectives and priorities, overcoming obstacles; and delivering results within project timelines and will build and maintain effective collaborations with Manufacturing, Manufacturing Support, Process Development, Analytical and Purification Sciences groups. Strong communication and technical writing skills are required. The incumbent will lead the design and execution of experiments for design & control of inocula, seed train, media, bioreactor, filtration and centrifugation unit operations. Appropriate GLP procedures must be followed. This position also involves troubleshooting and problem solving of process related problems observed at pilot scale, the evaluation of new process technologies through the effective design of scale-down studies and the evaluation of data from manufacturing lots. Provides technical expertise for design and execution of experiments for upstream process development including process improvements, media development, scale-down model development, new technology evaluation, tech transfer and pilot-scale support Demonstrates a strong knowledge of GLP lab practices, BMS corporate, site and regulatory agency requirements and procedures Supports process technology transfer to Pilot Scale Cell Culture facility Authors technical documents, including protocols, reports and SOPs supporting the communication of upstream process development, process descriptions and development summaries
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