Senior Process Development Engineer - Upstream

Role: Senior Process Development Engineer in upstream biologics process development, focusing on microbial upstream activities from seed train through primary recovery. Responsibilities: design, execute, and optimize scalable, high-yield, high-purity microbial processes (E. coli, P. pastoris, B. subtilis); support process transfer, validation, and manufacturing troubleshooting; review GMP documentation; lead process changes; serve as USP representative on CMC teams; coordinate with downstream, analytical, formulation, QC, and regulatory functions; prepare technical updates for leadership and external partners. Requirements: Bachelor's in engineering or equivalent experience; 8+ years industry experience with at least 5 years in GMP, development, or manufacturing environments; hands-on expertise in seed train, fermentation, centrifugation, cell lysis, and filtration at lab to pilot scale; proficiency with Sartorius systems and control software (e.g., DeltaV/ABB); familiarity with cGMP documentation; experience supporting engineering/clinical runs and process transfers; strong cross-functional communication skills. HighValue: biologics (upstream microbial), process development, GMP, process transfer, cGMP documentation, cross-functional collaboration, global travel up to 50%. WorkSetup: not specified.