Cell Therapy Production Associate, Oncology, 2nd Shift (Multiple Positions)

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� Description

• • Join Orca Bio’s state-of-the-art 100,000-square-foot GMP facility in Sacramento as a Cell Therapy Production Associate on 2nd shift (3:00 pm–11:30 pm, Monday–Friday) and directly contribute to manufacturing life-saving oncology cell therapies that could one day replace traditional stem-cell transplants for more than one million Americans battling blood cancer.
• • Execute and monitor advanced, automated cell-processing, expansion, and filling equipment in ISO 5/7 (Grade B/C) cleanrooms while strictly following SOPs, batch records, and cGMP regulations; maintain aseptic technique throughout every step to safeguard product purity and patient safety.
• • Perform in-process sampling, visual inspections, and environmental monitoring with 20/20 (corrected or uncorrected) vision and normal color perception to detect minute deviations in color-coded components, tubing sets, labels, and product appearance.
• • Calibrate, clean, and prepare bioreactors, centrifuges, cell washers, filling pumps, and single-use assemblies; troubleshoot alarms or process drift in real time, escalating complex issues to Manufacturing Engineering or QA to minimize batch impact and maintain on-time delivery.
• • Document every action contemporaneously in electronic batch records, logbooks, and LIMS; ensure data integrity, traceability, and compliance with FDA 21 CFR Part 11, EU Annex 11, and Orca Bio’s internal quality standards.
• • Partner cross-functionally with Materials Management to stage raw materials, with QC for in-process testing, and with QA for batch review and release; participate in deviation investigations, root-cause analyses, CAPA implementation, and change-control initiatives to drive continuous improvement.
• • Adhere to rigorous gowning protocols—full sterile garb including hood, goggles, face mask, coverall, and gloves—for extended periods; comply with restrictions on cosmetics, jewelry, or piercings and disclose any dermatological conditions that could compromise the cleanroom environment.
• • Contribute to tech-transfer activities, scale-up studies, and process-validation runs as the clinical pipeline advances toward commercialization; author or revise SOPs, work instructions, and training materials under the guidance of senior staff.
• • Participate in an on-call rotation for weekend or holiday manufacturing support, ensuring 24/7 readiness to respond to equipment alarms or urgent production needs; flexibility to work overtime as dictated by patient demand and batch scheduling.
• • Champion a culture of safety, quality, and respect; mentor new hires, lead by example, and embody Orca Bio’s core values of passion, courage, and integrity while working in a fast-paced, entrepreneurial environment that encourages curiosity and calculated risk-taking.