Supervisor, Materials and Cold Chain Operations - Night Shift

Orca Bio • Sacramento, CA

32d • $75,000 - $95,000 • Onsite

About The Position

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.
Day Shift Hours worked:
• 10:00 PM – 6:30 AM
• Coverage: Overnight ops, 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).

Requirements

• Bachelor’s degree in operations management, or supply chain plus 2 years of supervisory experience or
• 5 years of experience in cell therapy, biologics, pharmaceutical manufacturing or warehouse / supply chain with 2 years of supervisory experience
• Experience in material management and supply
• Experience in cold chain operations including cryopreservation and cold chain shipments
• Experience with Inventory management systems
• Strong understanding of good documentation practices and data integrity requirements.
• 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 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.
• Ability to lift 25 lbs
• Handling of cryogenic materials (liquid nitrogen systems)

Nice To Haves

• Preferred experience with FDA and Good Manufacturing Practice (GMP) knowledge
• Preferred experience with chain of identity and chain of custody controls.

Responsibilities

• 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.
• 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.
• 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.
• Support internal and external regulatory inspections and audits.
• Supervise and develop a direct reports
• Promote a safety-first and quality-first culture.
• Identify and implement process improvements in material flow, inventory control, and shipping operations.
• Recruits, interviews, hires, and trains new staff
• Oversees the daily workflow of the department
• Provides constructive and timely performance feedback and evaluations
• Resolves issues and escalates issues for support as needed

Benefits

• You will also be eligible to receive pre-IPO equity, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.
• Other perks include subsidized daily lunches and snacks at our on-site locations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level