Supervisor, Materials and Cold Chain Operations - Night Shift

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.

The Supervisor, Materials and Cold Chain Operations - Night Shift is responsible for overseeing daily operations associated with material supply, material handling, cryogenic storage, and cold chain packaging and shipping of cell therapy drug products. 

This role ensures that GMP-compliant handling, storage, packaging, and distribution of materials and drug products are performed safely, accurately, and in accordance with regulatory requirements, internal procedures, and chain-of-identity/chain-of-custody controls. 

The supervisor leads a team of material handlers and cryogenic processing/packaging specialists, ensuring operational readiness, inventory control, and timely shipment of critical materials and patient-specific drug products. 

Night Shift Hours worked:   • 10:00 PM – 6:30 AM • Coverage: Overnight operations, early morning handoff   Work Week Schedule:   •  Monday - Friday   Please note there will be on call rotation between Day Shift and Night Shift supervisors. This is to ensure coverage for the off hours (3:30pm - 10pm and weekends).

Essential Duties & Key Responsibilities:

Materials Supply:

• Ensure materials and drug product shipments align with manufacturing schedules and patient treatment timelines. 

• Coordinate activities for supplying GMP material for manufacturing, laboratory and facility operations 

• Support receipt, inspection, storage, and distribution of GMP materials. 

• Ensure proper inventory control within ERP/MES/WMS systems. 

• Ensure accurate chain-of-identity (COI) and chain-of-custody (COC) controls for patient-specific materials and drug products. 

Cold Chain Management:

• Oversee cryogenic and cold chain storage systems, including LN2 freezers and associated monitoring systems. 

• Supervise drug product cryopreservation handling and storage workflows. 

• Ensure compliant pack-out and shipment of cold chain drug products using validated shippers. 

• Coordinate shipments with couriers and logistics partners. 

• Ensure accurate chain-of-identity (COI) and chain-of-custody (COC) controls for patient-specific materials and drug products. 

Supervision:

• Ensure operations comply with: GMP (Good Manufacturing Practices), GDP (Good Distribution Practices), GTP (Good Tissue Practices) where applicable and Internal SOPs and regulatory requirements 

• Support quality investigations, deviations, CAPAs, and change controls. 

• Ensure proper documentation, batch record completion, and data integrity.