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

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� Description

• • Join Orca Bio’s 2nd-shift clinical manufacturing team and directly impact the lives of patients battling blood cancer. In this role you will execute high-precision, aseptic production runs of next-generation cell therapies that are designed to replace a patient’s blood and immune system with healthier, purified cells—dramatically lowering the risk of life-threatening complications such as graft-versus-host disease.
• • Every day you will operate state-of-the-art automated cell-processing, expansion, and filling equipment inside Grade B/C cleanrooms. You will follow detailed batch records and standard operating procedures (SOPs) to ensure every vial leaving the facility meets the same rigorous identity, purity, potency, and sterility specifications demanded by global regulators and, more importantly, by the patients who depend on us.
• • You will be the eyes and ears of the process—visually inspecting components, verifying color-coded labels, and quickly flagging any deviation before it can affect product quality. Your 20/20 vision (corrected or uncorrected) and normal color perception are critical tools in this effort, as is your ability to gown fully—hood, goggles, gloves, face covering—for extended periods without cosmetics, jewelry, or facial piercings that could compromise the cleanroom environment.
• • Between production runs you will clean, calibrate, and prepare equipment for the next campaign, ensuring that every line, sensor, and vessel meets validated cleanliness limits. You will meticulously document every step on controlled batch records, logbooks, and electronic systems, creating a complete data trail that can withstand FDA, EMA, and internal audits.
• • When alarms sound or process trends drift, you will troubleshoot in real time, escalating complex issues to senior staff while capturing all relevant data for deviation investigations. Your curiosity and attention to detail will feed continuous-improvement initiatives that shorten cycle times, reduce cost of goods, and improve right-first-time rates.
• • Collaboration is constant. You will work hand-in-hand with Materials Management to stage incoming raw materials, with Quality Control to release in-process samples, and with Quality Assurance to close batch records and change controls. Weekend or holiday on-call rotations may be required to ensure uninterrupted supply for clinical trials.
• • Physical demands include standing for long periods, repetitive fine-motor tasks, and occasional lifting of up to 25 lbs. You must be willing to work at either of our Sacramento sites—3400 Business Drive or 7910 Metro Air Parkway—depending on daily operational needs, and to join video-based meetings with colleagues across research, regulatory, and clinical functions.
• • Beyond technical execution, you will embody Orca Bio’s values of passion, courage, and integrity. Whether you are mentoring a new hire, suggesting a lean improvement, or simply sharing a laugh during a long shift, you will help maintain the start-up culture that makes our science—and our workplace—special.