Operations Supervisor, Logistics & Cold Chain

Job description

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 commercial-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 cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. **The Operations Supervisor, Logistics & Cold Chain Operations** leads the teams responsible for the secure, compliant, and on-time movement of donor cells and cell therapy drug products between Orca Bio's Sacramento manufacturing sites and transplant centers nationwide. This is a hands-on people- leadership role that owns end-to-end operational readiness across two functions: the Logistics Specialist team, which coordinates live courier runs, disruption response, chain-of-custody, and vein-to- vein (V2V) performance; and the cold chain / packaging operations hourly team, which prepares, charges, and qualifies shippers and executes GMP packing and handover. This is a hands-on leadership role. Reporting to the Logistics Program Manager, the Operations Supervisor owns full operational accountability for their team — staffing and qualification currency, KPI performance, real-time disruption response, and continuous improvement — and is expected to be present and available for their team through the parts of the day that matter most. Each Operations Supervisor partners closely with their day-side/night-side counterpart to ensure consistent leadership and a clean handoff between teams. The ideal candidate is a calm, decisive operator who builds strong teams, thrives in a fast-paced regulated environment, and can move fluidly between strategic planning and real-time problem-solving when a shipment is at risk. ### Physical Demands & Work Conditions - *Production Associate Roles*: 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. - *Most roles* must be able to 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. - *Many roles* must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs. ### 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.