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Sr. Engineering Associate/Associate Engineer, Drug Product Development

LocationBranchburg, New Jersey, United States
TypeOnsite
ApplyJob Type
Full-timeDescription  · Develop and implement manufacturing processes capable of supplying clinical trials with material complying to product quality targets, current Good Manufacturing Practices (cGMP), and regulatory requirements· Support the delivery of engineered immune cells to internal and external groups· Identify novel solutions to address key technical challenges required for manufacturing platform success, such as cryo-preservation and cell culture media optimization· Contribute to experimental strategy toward at-scale cell differentiation, expansion, formulation, and in-process testing· Collaborate with internal partners (Process Development, Analytical Development) to integrate stem cell process technology and optimize Century’s next-generation manufacturing process· Maintain laboratory procedures, systems and electronic notebooks, to ensure documentation of experimental activities· Travel up to 10%Requirements  · Experience with mammalian cell culture and media optimization· Experience with Rotea, LOVO, Xuri, and other cell culture unit operations is preferred· Understanding of cell biology/physiology and/or engineering fundamentals.

Experience with induced pluripotent stem cells (iPSC) is desirable· Understanding of bioprocess characterization and validation concepts, cGMP, and GLP· Dynamic and culturally astute team-player, scientifically rigorous with excellent communication skills

Qualifications:


· BS/MS degree in cell biology, biochemistry, biochemical engineering, or related field, ideally with 2-6 years of relevant industry experienceFunctional experience in mammalian cell culture process development, including molecular biology, aseptic techniques, and cryo-preservation

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