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

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� Description

• • Orchestrate the end-to-end manufacture of Orca Bio’s next-generation, high-precision cell therapies that are designed to replace a patient’s blood and immune system with a healthier one—directly impacting the lives of more than one million Americans currently fighting blood cancer.
• • Execute aseptic, GMP-compliant production runs in Grade B and C cleanroom suites, operating state-of-the-art automated cell-processing, expansion, and filling equipment while maintaining strict adherence to SOPs, batch records, and regulatory guidelines.
• • Perform in-process sampling, visual inspection, and real-time monitoring of critical quality attributes, leveraging 20/20 visual acuity (corrected or uncorrected) and normal color vision to detect minute deviations in color-coded components, tubing sets, and product labeling.
• • Maintain impeccable environmental control by donning full sterile gowning—hoods, goggles, face coverings, and multiple glove layers—for extended periods, and by following rigorous entry/exit procedures that eliminate microbial contamination risks.
• • Partner cross-functionally with Materials Management, QC, and QA teams to ensure seamless raw-material staging, in-process testing, and final-product release, while actively participating in deviation investigations, CAPA implementation, and change-control initiatives.
• • Champion continuous-improvement projects that drive manufacturing efficiency, reduce cycle times, and enhance product quality, including authoring or revising SOPs, batch records, and training materials under the guidance of the Commercial Manufacturing leadership team.
• • Document every critical step in real time using electronic batch records and controlled logbooks, ensuring data integrity, traceability, and compliance with FDA, EMA, and other global regulatory standards.
• • Clean, calibrate, and qualify equipment such as cell washers, centrifuges, incubators, isolators, and automated filling systems, following preventive-maintenance schedules and escalating any out-of-specification readings to engineering or metrology teams.
• • Participate in an on-call rotation that may require weekend or holiday coverage, ensuring uninterrupted supply of life-saving therapies to clinical sites and, ultimately, to patients in urgent need.
• • Contribute to a culture of safety, respect, and scientific curiosity by mentoring new hires, leading shift huddles, and sharing lessons learned from deviations or near-miss events.
• • Adapt to dynamic production schedules, working Monday–Thursday, 9:00 p.m.–7:30 a.m. at either of Orca Bio’s Sacramento locations (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational demand.
• • Engage in frequent video-based meetings with upstream process-development teams and downstream supply-chain partners to align on campaign forecasts, equipment readiness, and tech-transfer requirements.

� Requirements

• • Associate degree plus ≥1 year of biomanufacturing experience OR High School Diploma/GED plus ≥2 years of biomanufacturing experience
• • Demonstrated experience working in GMP-compliant cleanroom environments, preferably with cell or gene therapy products
• • 20/20 visual acuity (corrected or uncorrected) and normal color vision to perform visual inspections and distinguish color-coded components
• • Physical ability to meet cleanroom gowning requirements—including wearing full sterile PPE for extended periods—and to lift up to 25 lbs. occasionally
• • Flexibility to work 3rd shift (9 p.m.–7:30 a.m., Mon–Thu) and to support on-call, weekend, or holiday shifts as business needs dictate
• • Preferred: B.S. in Biological Sciences or related field; prior involvement in deviation investigations, CAPA, and change-control processes

️ Benefits

• • Competitive hourly wage of $23–$29 plus a 10% 3rd-shift differential
• • Pre-IPO equity participation, offering significant upside as Orca Bio advances toward commercialization
• • Comprehensive medical, dental, and vision coverage; 401(k) with company match; life, AD&D, and disability insurance; and generous parental leave
• • Flexible PTO policy that encourages true work-life balance and recognizes the demanding nature of late-shift operations
• • Daily catered lunches and fully stocked snack bars at both Sacramento sites, fostering community and convenience for night-shift team members