Night Shift: Packaging & Cold Chain for Cell Therapies

Orca Bio; Sacramento (CA); On-site; USD 65,465 - 71,571; Full time

Benefits offered by this job

Equity

Annual bonus

Medical benefits

PTO

401(k)

Life insurance

Parental leave

On-site meals

Job summary

Orca Bio is seeking an Associate for Packaging Operations and Cold Chain Handling on the Night Shift in Sacramento, CA. This role supports receipt of patient materials, cryopreservation, and coordination of final drug product shipments in a GMP environment.

The position requires a Life Sciences degree and 1–3 years in a GMP biotech setting, with emphasis on cryogenic systems and cleanroom work. Night hours run 6:00pm–6:30am, with weekend/holiday variation as needed.

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).

Responsibilities

• 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.
• 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.
• Coordinate the labeling, packaging, and final release of drug product for shipment.
• Prepare shipping materials, confirm shipping conditions, and liaise with logistics partners.
• Ensure real-time data entry into inventory, tracking systems and eBRs.
• 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.

Skills

GMP knowledge

Cell therapy

Cryogenic systems

Attention to detail

Documentation

Education

Bachelor’s degree in Life Sciences or related field

Tools

Cryogenic storage equipment

Job description

Orca Bio is seeking an Associate for Packaging Operations and Cold Chain Handling on the Night Shift in Sacramento, CA. This role supports receipt of patient materials, cryopreservation, and coordination of final drug product shipments in a GMP environment.

The position requires a Life Sciences degree and 1–3 years in a GMP biotech setting, with emphasis on cryogenic systems and cleanroom work. Night hours run 6:00pm–6:30am, with weekend/holiday variation as needed.