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Associate, Packaging Operations and Cold Chain Handling - Night Shift

Orca Bio·Sacramento, CA
full timeSacramento, CA

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AT A GLANCE

ManufacturingFull TimeRegular, Full-Time Employee

Preferred

  • 3+ years experience
Preferred qualifications are helpful, not automatic disqualifiers.
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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

About the role

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, Packaging Operations and Cold Chain Handling - Night 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. Night Shift Hours Worked: • 6:00pm to 6:30am or • 6:30pm to 7:00am Work Week Schedule: • Sunday, Monday, Tuesday + every other Wednesday or • Thursday, Friday, Saturday + every other Wednesday

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

Requirements

  • 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)
  • 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
PostedNot listed
Statusactive
CommuteDistance only

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