Manufacturing Associate

Title: Associate, Cell Therapy Manufacturing Location: Newark, CA 94560 Duration: 12 months Responsibilities include, but are not limited to: Perform process unit and support operations described in standard operating procedures (SOPs) and batch records including: PBMC, media and solution preparation; CAR-T cell drug substance preparation; and CAR-T drug product fill operations Accurate and timely completion of documentation required by protocols, SOPs, and batch records Maintain aseptic technique during processing of products to ensure the integrity, viability and sterility of cell therapy products from PBMC thaw to final formulated drug product cryopreservation Perform tasks in a manner consistent with safety policies, quality systems, and cGMP requirements Timely completion of training assignments to ensure the necessary technical skills and knowledge are applied compliantly during GMP operations Assist in setting up manufacturing areas and equipment, including complex automated cell processing, cell expansion and filling equipment Update and revise manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements Routinely monitor, clean, prepare and operate processing and analytical equipment in Grade B/C areas Follow all cleaning and gowning procedures for the facility Skills: Position Requirements & Experience: Bachelors or Associates in relevant science or engineering discipline with 0-2 years of experience in cGMP biologics or cell therapy manufacturing Aseptic processing in Grade A biosafety cabinets and Grade B clean rooms Cell culture processing experience in handling and propagation of human primary cells is strongly preferred Universal precautions for handling human derived materials in BSL-2 containment areas Knowledge of cGMP regulations and FDA guidance applicable to biologics and/or cell therapy #J-18808-Ljbffr ACL Digital