Sr Prod Spec Cell Therapy Cell Culture - Berkeley, CA

Role: Senior Product Specialist in Cell Therapy Cell Culture responsible for clinical manufacturing of cell therapy drug substances and products within the CTMOD platform. Main objectives include ensuring cGMP-compliant production across various stages of clinical to launch, supporting new product introductions, and optimizing manufacturing processes. Responsibilities encompass executing manufacturing activities such as cell expansion, differentiation, banking, and filling; developing and delivering training; managing equipment commissioning and validation; troubleshooting production issues; authoring controlled documents; and leading regulatory and internal audits. The role requires acting as a technical SME, collaborating with Biological Development and MSAT teams, and adapting to dynamic schedules for surgical and clinical demands. Qualifications: Bachelor’s in a relevant life science or engineering field, with 5–7 years of experience in cell therapy or biologics manufacturing, including hands-on experience with mammalian cell culture, aseptic processing, and SUT. Knowledge of cGMP, quality systems, and process validation is essential. Preferred qualifications include an advanced degree, over 7 years of experience including late-stage or commercial manufacturing, expertise in automation and electronic systems, and demonstrated leadership in cross-functional initiatives. The position is based in Berkeley, CA, with flexible hours and occasional off-hours work. Salary ranges from $93,840 to $140,760, with additional benefits.