Operations Supervisor, Logistics & Cold Chain

Physical Demands & Work Conditions

• Production Associates: 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 up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. 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.
• Must be comfortable regularly participating in video-based meetings.

Schedule & Team Presence:

This role is staffed as two positions one day and one night Supervisor.

These are on-site salaried leadership roles. Rather than working a set schedule, each Operations Supervisor is expected to be present for their team when it matters most — during active courier runs, shift handoffs, coverage gaps, onboarding, and non-routine events — and flex their hours to align with their team's rhythm and the demands of the operation. The two Operations Supervisors coordinate to maintain consistent leadership coverage and a clean handoff between the day and night teams.

Essential Duties & Key Responsibilities:

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

Minimum Experience, Education, Certifications, Licenses:

• Bachelor's degree and 5–7 years of relevant logistics or supply chain experience required. B.S. in biology, life sciences, supply chain, or logistics preferred.
• 2+ years of direct people-management experience, including hiring, scheduling, and performance management.
• Proven success leading logistics and/or cold chain operations, preferably in a regulated environment. Working knowledge of chain-of-custody requirements and cold chain handling of biological or pharmaceutical materials.
• Proficiency in logistics tracking systems or software required

Preferred Experience:

• Cell/gene therapy, biologics, or other time- and temperature-sensitive supply chain leadership.
• Managing a 24/7 or multi-shift operation with on-call coverage.
• Cold chain qualification and packaging operations (e.g., Credo, dry shippers, temperature monitoring, TrakSYS or equivalent MES/asset systems).
• Knowledge of IATA, DOT, and GMP/cGMP compliance; experience partnering with Quality on deviations and CAPAs.
• Courier / 3PL program management.
• Continuous improvement (Kaizen) , SOP development, and scaling operations in a startup or high-growth environment

Leadership & Personal Qualities:

• Builds, develops, and retains strong teams; leads by example regardless of title.
• Highly detail-oriented, with an unwavering commitment to quality, safety, and compliance.
• Decisive and composed under pressure; adapts quickly to change and keeps the team steadyduring disruptions.
• Takes ownership and drives forward without waiting for instruction.
• Naturally curious, eager to learn, and energized by solving problems.
• Communicates clearly and professionally with internal and external stakeholders.
• Comfortable juggling multiple priorities in a fast-paced, startup environment.
• Embraces a positive attitude, a collaborative spirit, and a good sense of humor

Reporting Structure & Authority:

Supervisory Responsibilities

• Directly manage the Logistics Specialists on your team, and oversee the cold chain/packaging operations hourly team.
• Own hiring, onboarding, scheduling, timekeeping approvals, performance management, coaching, and career development for your team across both functions.
• Partner with your dayside/night-side counterpart Operations Supervisor to align standards, share status, and execute a clean, documented handoff so nothing falls between teams.
• Maintain coverage and escalation paths for your team that protect V2V timelines without creating burnout or single points of failure.
•Ensure every team member maintains current training and qualification (including courier run currency and packaging-operations certifications) and that records are audit-ready.
• Be a visible, available escalation point for your team on non-routine transport and cold chain issues.