Cell Therapy Production Associate, Oncology, 3rd Shift (Multiple Positions)

📋 Description

• • Be the final guardian of life-saving cell therapies as you execute every critical step from sterile thaw to final product release, ensuring that each personalized oncology treatment meets the exacting standards required to give blood-cancer patients a second chance at life.
• • Own the complete 3rd-shift manufacturing workflow in ISO-14644 Grade B and C cleanrooms, operating cutting-edge automated cell washers, Sepax C-Pro systems, CliniMACS Prodigy units, and closed-system filling isolators while maintaining 100 % batch-record compliance and zero deviations.
• • Perform real-time environmental monitoring, viable/non-viable particle counts, and differential pressure checks, documenting results in validated electronic systems (e.g., MasterControl, Veeva Vault) to guarantee that every square foot of the suite remains in a state of continuous GMP control.
• • Conduct meticulous in-process sampling—cell counts, viability, sterility, endotoxin, mycoplasma—and interpret results on the spot, escalating any out-of-specification findings to QA and Process Sciences within minutes to protect product integrity and patient safety.
• • Stage, verify, and aliquot GMP-grade reagents, cytokines, and culture media under laminar flow hoods, cross-checking COAs, lot numbers, and expiry dates to eliminate the risk of mix-ups that could jeopardize a multi-million-dollar therapy batch.
• • Execute sterile filtration, pooling, and final fill-finish operations in Class A/B isolators, using peristaltic pumps, single-use tubing sets, and pre-sterilized vials, then apply tamper-evident seals and cryo-labels that withstand liquid nitrogen storage.
• • Lead deviation investigations and root-cause analyses for events such as temperature excursions, pressure alarms, or microbial hits, authoring CAPA plans that prevent recurrence and sharing lessons learned in quarterly cross-site forums.
• • Calibrate and qualify critical equipment (e.g., BioTek plate readers, Vi-CELL XR, Endosafe Nexgen) according to validated IQ/OQ/PQ protocols, coordinating with Metrology to maintain NIST-traceable standards and ensure measurement accuracy.
• • Mentor junior associates by delivering hands-on training in aseptic technique, gowning proficiency, and electronic batch-record navigation, building a resilient night-shift team capable of autonomous operation.
• • Participate in tech-transfer activities as new oncology indications move from Process Development to Commercial Manufacturing, reviewing batch records, drafting risk assessments, and executing engineering runs under the guidance of MSAT scientists.
• • Drive lean-manufacturing initiatives—Kanban boards, 5S audits, SMED events—that reduce changeover times, cut consumable waste, and increase overall equipment effectiveness (OEE) across the 3rd-shift portfolio.
• • Maintain impeccable documentation culture: contemporaneous entries, ALCOA+ principles, and secure electronic signatures that withstand FDA, EMA, PMDA, and health-authority inspections.
• • Collaborate with Supply Chain to ensure just-in-time delivery of single-use kits, viral vectors, and cryopreservation bags, flagging any forecast gaps that could delay patient dosing schedules.
• • Uphold rigorous safety standards by completing monthly BSL-2 training, chemical hygiene refreshers, and ergonomic assessments, reporting near-miss events in real time via the EHS portal.
• • Adapt to dynamic campaign timelines, seamlessly switching between autologous CAR-T and allogeneic TCR therapies while maintaining the same zero-defect mindset that defines Orca Bio’s brand promise to patients and clinicians.