Logistics Manager (Cell & Gene Therapy)

Reports To: Chief Technical Officer (CTO) Location: Dallas, TX (in-office) or Possible Remote (U.S.) Department: Technical Operations / CMC / Supply Chain Position Summary The Logistics Manager will own and execute all logistics and distribution activities for an allogeneic cell and gene therapy program, operating in a foundational, hands-on role within a highly outsourced development and manufacturing network. This role ensures the compliant, reliable, and efficient movement of materials among CDMOs, analytical and process development (AD/PD) partners, storage depots, and clinical sites across the United States. The role emphasizes inventory-based distribution, product and material traceability, and clinical network coordination according to patient scheduling. Reporting directly to the CTO, the Logistics Manager will execute day-to-day shipments while building the logistics infrastructure required to scale through clinical development and toward commercialization. This position is responsible for the complete supply cold chain process including inventory management.

Key Responsibilities

End-to-End Logistics Execution (Primary Focus)

• Coordinate and execute all inbound, inter-site, and outbound shipments across CDMOs, AD/PD partners, depots, and clinical sites
• Manage temperature-controlled logistics across frozen and cryogenic conditions, including

Master Cell Banks (MCBs) and finished drug product

• Prepare and review shipping documentation (BOLs, labels, permits, chain-of-custody records, etc.)
• Monitor shipments in real time; manage delays or excursions proactively; and drive issue resolution
• Maintain chain-of-custody and batch traceability across all movements

Sponsor-Managed Materials & Sample Logistics

• Own end-to-end logistics for

sponsor-managed manufacturing materials , including ordering, inventory tracking, storage coordination, and shipment to CDMOs and partners

• Coordinate procurement and delivery timelines aligned with manufacturing and development schedules
• Track material consumption, replenishment, and disposition across external sites
• Coordinate shipment of

analytical, in-process, and release testing samples among CDMOs, testing laboratories, and internal stakeholders

• Ensure compliant handling, labeling, documentation, and traceability of samples (as applicable under GxP)

External Network Coordination

• Act as the central logistics point of contact for the partner network, including CDMOs, analytical labs, and storage facilities
• Coordinate shipment readiness, release timing, and delivery windows across organizations
• Align logistics activities with manufacturing schedules, QC release timelines, and clinical demand forecasts
• Set and reinforce consistent standards and expectations with external partners

Inventory & Distribution Management (Allogeneic Focus)

• Support inventory tracking and positioning of MCBs and drug product across storage locations and clinical sites
• Coordinate depot shipments, site resupply, and returns
• Maintain accurate records for lot traceability, reconciliation, and disposition
• Support distribution strategies aligned with clinical trial enrollment and site activity

Function Buildout & Process Development

• Develop and implement SOPs, work instructions, and templates for logistics and distribution
• Standardize shipment workflows across external partners
• Build scalable processes to support increasing clinical volume and complexity
• Develop documentation and frameworks to support future team growth

Vendor & Partner Management (Hands-On)

• Identify, onboard, and manage specialty couriers, 3PLs, depots, and cold chain providers within the U.S.
• Define service expectations, monitor performance, and resolve operational issues
• Maintain working relationships with partner logistics teams at CDMOs and labs

Regulatory Compliance & Quality Interface

• Ensure logistics activities comply with applicable GxP, GDP, DOT, and U.S. regulatory requirements
• Partner with Quality Assurance on SOPs, deviations, CAPAs, and audit readiness
• Maintain inspection-ready documentation for shipments and logistics processes

Systems, Tracking & Data

• Implement and manage shipment tracking and temperature monitoring systems
• Maintain shipment and inventory movement records, including supporting documentation· De