Orca Bio · 1 day ago
Associate, Cell Therapy Handling and Cryopreservation
Orca Bio is a late-stage biotechnology company focused on redefining the transplant process for blood cancer patients through innovative cell therapies. The Associate, Cell Therapy Handling and Cryopreservation will support critical operations related to the receipt, cryopreservation, and shipment of cellular products, ensuring compliance with GMP standards.
HealthcarePharmaceuticalHealth CareMedical
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 (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
Qualification
Required
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)
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
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
May involve standing for extended periods and lifting up to 25 lbs
Exposure to human blood products and temperature-controlled storage areas
Gowning and use of Personal Protective Equipment required
Benefits
Pre-IPO equity
Competitive medical, dental, and vision benefits
PTO
401(k) plan
Life and accidental death and disability coverage
Parental leave benefits
Subsidized daily lunches and snacks at our on-site locations
Company
Orca Bio
Orca Bio is a clinical-stage cell therapy company dedicated to delivering curative medicine to patients.
H1B Sponsorship
Orca Bio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (3)
2023 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Late StageTotal Funding
$542MKey Investors
Lightspeed Venture PartnersSilicon Valley Bank
2026-01-09Series F· $250M
2026-01-09Debt Financing· $100M
2020-06-17Series D· $192M
Recent News
2026-02-05
Company data provided by crunchbase