Supervisor, Materials and Cold Chain Operations - Day Shift
The Materials and Cold Chain Operations Supervisor 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.
The Materials and Cold Chain Operations Supervisor 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.
Essential Duties & Key Responsibilities:
Materials Supply:
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Ensure materials and drug product shipments align with manufacturing schedules and patient treatment timelines.
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Coordinate activities for supplying GMP material for manufacturing, laboratory and facility operations
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Support receipt, inspection, storage, and distribution of GMP materials.
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Ensure proper inventory control within ERP/MES/WMS systems.
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Ensure accurate chain-of-identity (COI) and chain-of-custody (COC) controls for patient-specific materials and drug products.
Cold Chain Management:
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Oversee cryogenic and cold chain storage systems, including LN2 freezers and associated monitoring systems.
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Supervise drug product cryopreservation handling and storage workflows.
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Ensure compliant pack-out and shipment of cold chain drug products using validated shippers.
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Coordinate shipments with couriers and logistics partners.
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Ensure accurate chain-of-identity (COI) and chain-of-custody (COC) controls for patient-specific materials and drug products.
Supervision:
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Ensure operations comply with: GMP (Good Manufacturing Practices), GDP (Good Distribution Practices), GTP (Good Tissue Practices) where applicable and Internal SOPs and regulatory requirements
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Support quality investigations, deviations, CAPAs, and change controls.
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Ensure proper documentation, batch record completion, and data integrity.
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Support internal and external regulatory inspections and audits.
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Supervise and develop a direct reports
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Promote a safety-first and quality-first culture.
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Identify and implement process improvements in material flow, inventory control, and shipping operations.
Minimum Experience, Education, Certifications, Licenses:
- Bachelor’s degree in operations management, or supply chain plus 2 years of supervisory experience or
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5 years of experience in cell therapy, biologics, pharmaceutical manufacturing or warehouse / supply chain with 2 years of supervisory experience
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Experience in material management and supply
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Experience in cold chain operations including cryopreservation and cold chain shipments
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Experience with Inventory management systems
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Preferred experience with FDA and Good Manufacturing Practice (GMP) knowledge
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Preferred experience with chain of identity and chain of custody controls.
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Strong understanding of good documentation practices and data integrity requirements.
Key Competencies:
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Operational leadership
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Attention to detail and quality mindset
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Strong organizational and planning skills
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Ability to manage time-critical patient product shipments
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Cross-functional communication
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Problem solving and continuous improvement
Reporting Structure & Authority:
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Direct reports include: Material Handlers and Handling and Cryopreservation Associates
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Define Supervisory responsibilities:
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Recruits, interviews, hires, and trains new staff
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Oversees the daily workflow of the department
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Provides constructive and timely performance feedback and evaluations
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Resolves issues and escalates issues for support as needed
Physical Demands:
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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.
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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.
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Work environment includes:
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Ability to lift 25 lbs
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Handling of cryogenic materials (liquid nitrogen systems)
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May require shift, weekend, or holiday coverage to support manufacturing and patient treatment timelines.
