Associate, Cell Therapy Handling and Cryopreservation

📋 Description

• • You are the last line of defense between a fragile cell therapy and the patient whose life depends on it. Every leukapheresis unit that lands on your bench has already traveled hundreds of miles; your job is to ensure it completes the final miles with identity, potency, and sterility intact. In this role you will own the critical hand-off points that determine transplant success or failure.
• • Receive, inspect, and log incoming leukapheresis units with surgical precision—verifying temperature, packaging integrity, and labeling against SOPs and regulatory requirements—so that no patient ever receives the wrong product.
• • Execute controlled-rate freezing protocols on intermediate and final cell products, operating liquid-nitrogen freezers, controlled-rate freezers, and vapor-phase storage tanks while documenting every parameter in electronic batch records and LIMS.
• • Coordinate the final choreography of drug-product release: printing compliant labels, assembling insulated shippers, confirming temperature monitors, and partnering with logistics couriers to guarantee on-time delivery to transplant centers across the country.
• • Maintain absolute chain-of-identity and chain-of-custody through barcode scanning, tamper-evident sealing, and real-time inventory updates, eliminating the risk of mix-ups that could cost a patient their life.
• • Serve as the primary interface between Manufacturing, Quality Assurance, and Supply Chain, escalating deviations within minutes, initiating CAPAs, and participating in cross-functional troubleshooting sessions that continuously tighten our processes.
• • Work inside ISO-7 cleanrooms for up to 8 hours per shift, fully gowned (hood, goggles, mask, gloves, boots) in 4°C cold rooms and adjacent to –196°C LN2 storage, while adhering to strict no-cosmetics and no-jewelry policies to protect product sterility.
• • Perform visual inspections under bright LED light to detect microscopic clumps, discoloration, or compromised seals, leveraging 20/20 vision (corrected acceptable) and normal color perception to distinguish color-coded components and labels.
• • Lift, move, and inventory cryoboxes and shippers weighing up to 25 lbs, climb step stools to access overhead LN2 tanks, and stand for extended periods without compromising aseptic technique or documentation accuracy.
• • Contribute to tech-transfer projects and process-improvement initiatives—whether that means qualifying a new freezer, revising a batch record, or piloting RFID tracking—to scale our capacity as we advance toward commercial launch.
• • Document every action contemporaneously in electronic systems compliant with 21 CFR Part 11, GDP, and cGMP, ensuring audit-readiness at all times and enabling rapid traceability during regulatory inspections.
• • Embrace a culture where urgency meets compassion: you will see the patient’s name on every bag you freeze, reminding you that precision today can restore someone’s tomorrow.