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

Orca Bio, Inc.

Job Overview

Location

Sacramento, CA

Job Type

Full-time

Full Job Description

📋 Description

• Step into the heart of life-saving science as an Associate, Cell Therapy Production on Orca Bio’s 3rd shift. In our 3400 Business Drive facility in Sacramento, you will manufacture next-generation allogeneic cell therapies that slash transplant-related mortality and give hope to the one million Americans living with blood cancers and other hematologic disorders. Every sterile fill, every controlled-rate freeze, and every batch record you sign is a potential cure delivered to a patient who has exhausted all other options.
• Own end-to-end GMP manufacturing Monday–Thursday, 9:00 PM–7:30 AM. You will execute cell isolation, activation, expansion, harvest, formulation, fill-finish, and cryopreservation using closed-system bioreactors, automated cell washers, centrifuges, and vapor-phase liquid nitrogen freezers. Your meticulous adherence to batch records and SOPs guarantees that each dose meets identity, purity, potency, and sterility specifications before release.
• Perform real-time in-process monitoring and sampling, capturing critical parameters such as viable cell counts, flow-cytometry immunophenotyping, pH, dissolved oxygen, and endotoxin levels. You will enter data directly into validated electronic systems (LIMS, MES, eBR) and immediately flag deviations, initiating investigations and CAPAs when results drift outside validated ranges.
• Maintain Grade B/C cleanroom readiness by executing daily sanitizations, environmental monitoring, and preventive maintenance on all production equipment. Full sterile gowning—hood, coverall, goggles, double gloves, and face mask—is provided and required for up to 10-hour shifts. Your vigilance keeps microbial excursions at zero and ensures continuous regulatory compliance.
• Stage raw materials and single-use consumables in partnership with Materials Management, verify incoming certificates of analysis, and perform incoming QC checks. You will coordinate with QC for rapid microbial and analytical testing and with QA for batch review, deviation closure, and final release, ensuring that every therapy lot is IND-compliant and BLA-ready.
• Drive continuous-improvement initiatives: 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 will help transition processes from clinical to commercial readiness, directly impacting cost of goods and patient access.
• 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. You will be the go-to responder for off-shift alarms, using your troubleshooting skills to keep bioreactors running and freezers at –150 °C.
• Uphold Orca’s safety-first culture by completing all required training modules—cGMP, biosafety, hazmat, ergonomic lifting, chemical hygiene—and by mentoring new hires through a structured buddy program. Demonstrate our core values—passion, courage, integrity—by openly sharing observations, driving transparent communication, and celebrating every successful batch release with the team.
• 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.

🎯 Requirements

• Bachelor’s degree in biology, biochemistry, biomedical engineering, or related life-science field OR 2+ years of hands-on GMP manufacturing experience in cell therapy, biologics, or sterile pharmaceuticals
• Demonstrated proficiency with aseptic technique, cell culture, and closed-system bioprocessing equipment (bioreactors, centrifuges, fill-finish isolators)
• Ability to lift up to 50 lbs, stand for extended periods, and work safely in a cleanroom environment wearing full sterile gowning for up to 10-hour shifts
• Flexibility to work 3rd shift (9:00 PM–7:30 AM, Monday–Thursday) and participate in an on-call rotation approximately one weekend per month
• Strong written and verbal communication skills; experience with electronic batch records, LIMS, MES, or similar GMP documentation systems preferred

🏖️ Benefits

• 100% employer-paid medical, dental, and vision insurance for employees and 80% for dependents, plus life and disability coverage
• 401(k) with 4% company match and immediate vesting, plus annual performance bonus tied to company milestones
• 15 days PTO to start, 12 company holidays, and a paid volunteer day, with flexible scheduling for the on-call rotation
• Daily on-site meals, snacks, and beverages; ergonomic sit-stand workstations; and a fully stocked cleanroom break room
• Relocation assistance and tuition reimbursement for approved continuing-education courses or advanced degrees

Skills & Technologies

Junior

Onsite

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Orca Bio, Inc.

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About Orca Bio, Inc.

Orca Bio is a clinical-stage cell therapy company developing high-precision allogeneic stem cell and T-cell therapeutics to treat blood cancers, genetic disorders and autoimmune diseases. Its proprietary Orca-Q platform enables precise purification and formulation of donor-derived cell subsets to reduce graft-versus-host disease and improve engraftment outcomes. The company is advancing multiple Phase 2/3 trials in hematopoietic stem cell transplantation and has partnerships with leading transplant centers to commercialize next-generation cellular medicines.

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