Sr Prod Spec Cell Therapy Cell Culture - Berkeley, CA

Role: Senior Product Specialist in Cell Therapy Cell Culture, focusing on clinical manufacturing of innovative cell therapy products within Bayer's Berkeley facility. Responsibilities: oversee manufacturing activities across multiple operations such as solution prep, cell expansion, differentiation, banking, and drug product filling; support products from clinical to launch stages ensuring cGMP compliance; develop and deliver training; lead new product introductions and process optimization; author and review controlled documents; troubleshoot equipment and processes; participate in audits and safety investigations. Requirements: Bachelor's in life sciences or engineering; 5-7 years in cell therapy or biologics manufacturing, with hands-on experience in mammalian cell culture, aseptic processing, and SUT; strong understanding of cGMP regulations, documentation, and process validation; supporting or leading NPIs and tech transfers preferred. HighValue: biologics, cell therapy (ATMP), clinical to launch phases, cGMP, equipment commissioning, process troubleshooting, automation, auditing, cross-functional collaboration. WorkSetup: on-site Berkeley; flexible hours and occasional extended shifts.