Team Leadership & Shift Coverage
• Lead, develop, and retain a cross-trained logistics and cold chain team, setting clear
expectations, standards, and accountability.
• Be present and available for the team during active runs, handoffs, and coverage crunches, adjusting hours to when leadership presence matters most.
• Balance workload across sites (SAC-01 / SAC-02) based on batch volume and operational demand.
• Run structured handoffs with your counterpart Operations Supervisor so active runs, at-risk shipments, and open issues transfer cleanly between the day and night teams.
Logistics Operations & Vein-to-Vein Performance
• Own vein-to-vein (V2V) performance for the network; monitor KPIs, identify trends, and drive corrective and preventive action when targets are missed.
• Oversee real-time coordination of active courier runs, ensuring proactive tracking of flights, weather, and disruptions.
• Direct disruption and incident response: flight and hotel rebooking, itinerary and TSA letter re- issuance, negotiating with third parties to ensure minimal delays.
• Partner with manufacturing, case management, and clinical scheduling to triage the impact of delays on batch and delivery timelines.
Cold Chain & Packaging Operations Oversight
• Ensure cold chain readiness across the operation, including Credo and dry-shipper charging, preparation, qualification, and recirculation.
• Oversee GMP packing, asset checkout and batch assignment in TrakSYS, final handover, chain- of-custody execution, and shipping-condition confirmation.
• Maintain adequate qualified shipper inventory and asset availability to meet forecasted batch demand.
• Ensure temperature monitoring, data upload, and excursion response are handled promptly and documented correctly.
Chain of Custody, Compliance & Quality
• Ensure chain-of-custody (CoC) documentation, temperature data, and return-of-materials tracking are complete, accurate, and compliant.
• Maintain compliance with GMP/cGMP, IATA, DOT, and applicable transport and cold chain regulations.
• Partner with Quality on deviations, CAPAs, and audit readiness; ensure SOPs are current and consistently followed.
• Update delivery times in OrcaLink and ensure V2V capture for KPI reporting.
Courier / Orca Porter Program & Vendor Management
• Partner with the Logistics Program Manager in owning the Orca Porter courier program, including courier scheduling, flight and travel logistics, and performance tracking and optimization.
• Partner in leading third-party (3PL) courier implementation, vendor relationships, and issue resolution.
• Review and approve courier invoices, and manage cost and performance across airlines, travel providers, and 3PLs.
• Oversee commercial site feasibility assessments and dry-run support for new and existing treatment centers.
Continuous Improvement & Scale
• Continuously evaluate and improve logistics and cold chain workflows to support operational scalability and commercial growth.
• Contribute to and maintain training programs, SOPs, and qualification frameworks.
• Support capacity planning, tooling, and process changes that increase reliability and throughput as volume grows.
Cross-Functional Partnership
• Partners closely with Manufacturing, Quality, Clinical Scheduling, Commercial Case Management, and external donor and recipient organizations.
• Represents Logistics & Cold Chain in operational planning, readiness reviews, and cross- functional projects