Manager, CSV Cell Therapy

Role: Manager, CSV Cell Therapy, responsible for overseeing qualification, validation, and support of manufacturing and laboratory equipment and systems at multi-use sites within the cell therapy division. Core responsibilities include ensuring compliance with regulatory standards (cGXP, CFR21 Part 11), managing equipment qualification activities, investigating deviations, and leading validation projects for equipment lifecycle and computerized systems. The role involves supervising vendors, authoring validation documents, and supporting equipment implementation projects. Requirements: BS degree or equivalent with minimum 5 years in FDA-regulated environments, strong knowledge of cGXP, validation protocols, and pharmaceutical systems, and experience with equipment qualification and documentation. Preferred: experience in cell therapy manufacturing or laboratory systems, project management skills, and regulatory audit support. High-Value: focus on cell therapy modalities, GMP manufacturing, validation, and regulatory compliance; interacts with manufacturing, QC, QA, and facilities teams. Work setup: hybrid onsite at Summit West, NJ; role may involve entering GMP areas with appropriate PPE, with physical and environmental demands aligned with laboratory and manufacturing environments.