Cell Therapy Production Associate, Oncology, 1st Shift (Multiple Positions)

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� Description

• • Be at the forefront of saving lives: every day you will manufacture Orca Bio’s next-generation, high-precision cell therapies that replace a patient’s blood and immune system and give more than one million Americans fighting blood cancer a dramatically safer alternative to traditional stem-cell transplants.
• • Own the full GMP production cycle in our brand-new, 100,000-square-foot Sacramento facility. You will set up, operate, and monitor state-of-the-art automated cell-processing, expansion, and filling equipment inside ISO-5/Grade B and Grade C cleanrooms, ensuring every batch meets the highest purity, potency, and identity specifications before release to clinical sites.
• • Execute and continuously refine Standard Operating Procedures (SOPs) and electronic batch records with meticulous attention to detail, documenting every critical step in real time so that each therapy lot is fully traceable and compliant with FDA cGMP, EMA, and company quality standards.
• • Partner cross-functionally with Materials Management, QC, and QA to stage raw materials, perform in-process sampling, review analytical data, and release finished product, enabling seamless hand-offs that keep clinical trials on schedule and future commercial supply uninterrupted.
• • Champion a culture of continuous improvement by identifying process gaps, participating in deviation investigations, CAPA, and change-control initiatives, and presenting data-driven recommendations that increase yield, reduce cycle time, and lower cost of goods while never compromising patient safety.
• • Maintain a pristine production environment: perform daily clean-in-place (CIP) and steam-in-place (SIP) cycles, execute environmental monitoring, and ensure all equipment is calibrated, qualified, and ready for the next campaign, meeting or exceeding all regulatory and internal audit expectations.
• • Rotate through on-call weekend and holiday shifts as needed to support 24/7 manufacturing, demonstrating flexibility and commitment to patients whose treatment windows cannot wait.
• • Uphold strict gowning and aseptic behaviors—full sterile garb, 20/20 vision (corrected OK), no cosmetics or jewelry—and model these standards for new team members, ensuring the cleanroom remains a contamination-free zone at all times.
• • Engage in ongoing technical training, competency assessments, and safety drills to stay current with evolving cell-therapy technologies, automation upgrades, and regulatory guidance, turning curiosity and scientific rigor into personal growth and team excellence.
• • Contribute to a mission-driven, start-up culture where titles don’t matter but impact does: bring passion, courage, and integrity to every interaction, celebrate diverse perspectives, and help build an inclusive workplace that reflects the patients and communities we serve.