Associate, Packaging Operations and Cold Chain Handling - Night Shift

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

Physical Demands & Work Conditions

• 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 meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. 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.
• Must be comfortable regularly participating in video-based meetings.

Physical Demands

• 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.
• 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.

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