Associate Principal Scientist, Upstream Process Development
$142,400–$224,100 year
On-site · Rahway, New Jersey, United States
Job Summary
Associate Principal Scientist in Upstream Process Development leading and contributing to high-yield, robust, scalable cell culture processes for first-in-human and commercial programs; responsible for process development, characterization, and regulatory filing activities to support PPQs and BLAs; collaborate with Discovery, Cell Line, Downstream Process Development, Analytical Sciences, and Manufacturing to deliver integrated clinical and commercial process solutions; drive platform improvements to enhance efficiency and reduce costs; engage with academia, industry partners, and vendors to advance new process technologies; demonstrate strong scientific leadership, cross-functional collaboration, and ability to mentor junior staff; required expertise includes mammalian cell culture (CHO), fed-batch processes, experimental design and analysis (DOE, multivariate analysis), and experience with bioreactor scale-up from bench to pilot/commercial scales; proven ability to plan, execute, analyze, and communicate complex data, with excellent written and verbal communication skills; familiarity with regulatory considerations and tech transfer in biologics CMC; strong publication/presentation track record and ability to work in a matrixed team environment.
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