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

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� Description

• • Join the frontline of cell-therapy innovation as an Associate, Cell Therapy Production on Orca Bio’s 3rd shift team. Every batch you manufacture is a potential lifeline for the one million Americans battling blood cancers and other hematologic disorders. Working in our state-of-the-art, 3400 Business Drive facility in Sacramento, you will operate cutting-edge, closed-system equipment to purify and formulate next-generation allogeneic cell therapies that dramatically reduce the risks of traditional stem-cell transplants.
• • Execute end-to-end GMP manufacturing runs Monday–Thursday, 9:00 PM–7:30 AM, following detailed batch records and SOPs for cell isolation, activation, expansion, harvest, fill-finish, and controlled-rate freezing. Your precision ensures every dose meets release specifications for identity, purity, potency, and sterility.
• • Perform real-time in-process monitoring and sampling, recording critical parameters such as cell counts, viability, flow-cytometry markers, and environmental data in compliant electronic systems (LIMS, MES, eBR). You will be the first line of defense against deviations, initiating investigations and CAPAs when results drift outside validated ranges.
• • Maintain Grade B/C cleanroom readiness by executing daily sanitations, calibrations, and preventive-maintenance tasks on bioreactors, centrifuges, cell washers, automated fill-finish isolators, and vapor-phase liquid nitrogen freezers. Full sterile gowning (hood, coverall, goggles, double gloves, face mask) is provided and required for up to 10-hour shifts.
• • Collaborate cross-functionally with Materials Management to stage raw materials and single-use consumables, with QC for rapid microbial and analytical testing, and with QA for batch review and release. Your accurate documentation directly supports IND-enabling studies and future BLA submissions.
• • Champion continuous-improvement projects: map process flows, reduce cycle times, eliminate non-value-added steps, and author technical reports that feed into scale-up and tech-transfer activities. Your insights help transition processes from clinical to commercial readiness.
• • Participate in an on-call rotation (approximately one weekend per month) to support emergency manufacturing or equipment troubleshooting, ensuring uninterrupted supply for ongoing Phase II/III trials.
• • Uphold a safety-first culture by completing all required training (cGMP, biosafety, hazmat, ergonomic lifting, chemical hygiene) and mentoring new hires through a structured buddy program. Demonstrate Orca’s core values—passion, courage, integrity—by openly sharing observations and driving transparent communication.
• • Contribute to a respectful, inclusive workplace where curiosity, humor, and scientific rigor coexist. Whether you are troubleshooting a clogged filter at 2:00 AM or presenting a root-cause analysis at the morning stand-up, your voice matters and your work directly impacts patient survival.