Associate, Packaging Operations and Cold Chain Handling - Day Shift

Job description

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. The **Associate, Cell Therapy Handling and Cryopreservation - Day Shift** supports critical operations related to the receipt of patient materials (leukapheresis/blood), cryopreservation of cellular products, and preparation and coordination of final drug product shipments. This role will operate with a deep understanding of GMP manufacturing, cell therapy processes, and the ability to execute multiple tasks in a fast-paced environment. **Day Shift Hours Worked:** • 6:00am to 6:30pm ***or*** • 6:30am to 7:00pm **Work Week Schedule:** • Sunday, Monday, Tuesday + every other Wednesday ### Physical Demands & Work Conditions - *Production Associate Roles*: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment. - *Most roles* must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed. - *Many roles* must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs. ### Essential Duties & Key Responsibilities - **Blood Intake & Chain-of-Identity Management:** - Receive and verify incoming apheresis materials according to SOPs and regulatory requirements. - Perform visual inspections and documentation checks to ensure proper labeling, temperature, and packaging. - Maintain strict adherence to chain-of-identity and chain-of-custody procedures. - **Cryopreservation Support:** - Assist in the preparation and cryopreservation of intermediate and final cellular products. - Operate and maintain cryogenic storage equipment (e.g., controlled-rate freezers, LN2 tanks). - Accurately complete batch records and electronic documentation systems. - **Drug Product Shipment:** - Coordinate the labeling, packaging, and final release of drug product for shipment. - Prepare shipping materials, confirm shipping conditions (e.g., temperature control), and liaise with logistics partners. - Ensure real-time data entry into inventory, tracking systems and eBRs - **Perform other duties as assigned** - Work closely with Quality Assurance, Supply Chain, and Manufacturing teams to ensure timely and compliant operations. - Support deviation investigations, CAPAs, and continuous improvement initiatives as needed. - Maintain accurate and complete records in accordance with GMP and GDP standards. - Good Manufacturing Practices (GMP) Training ### Minimum Qualifications - Bachelor’s degree in Life Sciences, Engineering, or related field preferred. - 1-3 years of experience in a GMP-regulated biotech or pharmaceutical environment preferred. - Strong understanding of cell therapy manufacturing processes - Strong attention to detail, organizational skills and document accuracy. - Ability to work with biological materials and cryogenic systems - Knowledge of regulatory compliance (FDA and GxP) a plus - Comfortable working in a clean room and or cold environment (Liquid Nitrogen storage) ### Travel Requirements and Work Environment - Domestic and international travel not required - May involve standing for extended periods and lifting up to 25 lbs - Shift work, weekends, or holidays may be required depending on production needs - Exposure to human blood products and temperature-controlled storage areas - Gowning and use of Personal Protective Equipment required