Associate, Production Support

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 late-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 investigational 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, Production Support 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 executemultiple tasks in a fast-paced environment. 

Physical Demands

• Production Associates: 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.
• 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.

Work Conditions

• Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs.
• Must be comfortable regularly participating in video-based meetings.
• May be required to work scheduled overtime, weekends, or holidays based on business needs.

• Blood Intake & Chain-of-Identity Management: Receive and verify incoming apheresis materials in accordance with SOPs and regulatory requirements, performing visual inspections to ensure correct labeling, temperature, and packaging. Maintain strict compliance with chain-of-identity and chain-of-custody procedures.
• Cryopreservation Support: Assist with the preparation and cryopreservation of cellular products, operate and maintain cryogenic storage equipment, and ensure accurate completion of batch records and electronic documentation.
• Drug Product Shipment: Coordinate labeling, packaging, and final release of drug products for shipment, ensuring proper shipping conditions and real-time data entry into inventory, tracking systems, and electronic batch records. Liaise with logistics partners to support timely and compliant delivery.
• Perform other duties as assigned: Collaborate with Quality Assurance, Supply Chain, and Manufacturing to ensure timely, compliant operations. Support deviation investigations, CAPAs, and continuous improvement efforts while maintaining accurate records in compliance with GMP and GDP standards.

Minimum Experience, Education, Certifications, Licenses:

• 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 cleanroom and or cold environment (Liquid Nitrogen storage) 
• Good Manufacturing Practices (GMP) Training  

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 

The anticipated annual salary range for this job is based on prior experien