Manufacturing Associate, Liso-cel CAR-T, Manufacturing Operations

Role: Manufacturing Associate in cell therapy production, supporting the manufacture of human blood-derived components within a cGMP environment. Responsibilities: operate equipment for cell culture, harvest, and cryopreservation; support deviation investigations and CAPA closures; perform aseptic tasks and record data per GDP standards; uphold safety, quality, and GMP compliance; collaborate within cross-functional teams; and contribute to continuous improvement initiatives. Requirements: High School diploma required; Bachelor's or associate degree preferred; 0-1 year experience in cGMP cell therapy or bioprocessing manufacturing; knowledge of cell culture, cryopreservation, aseptic processing, and GMP/FDA regulations; basic math, technical writing, proficiency in MS Office; understanding of biology, chemistry, or clinical practices. High-Value: support for blood cell therapy manufacturing, working in a controlled cGMP cleanroom environment, with a focus on process adherence and quality documentation. Work setup: onsite night shift (Wednesday–Saturday, 5 p.m. – 5:30 a.m.) in Summit West, NJ, with physical and safety requirements typical of cleanroom environments.