Director, Cell Therapy Logistics Operation

AstraZeneca•Gaithersburg, MD

1d•Hybrid

About The Position

Introduction to role: Are you ready to build and scale a vein-to-vein logistics engine that turns cutting-edge cell therapies into real outcomes for patients? In this director role, you will lead end-to-end scheduling and logistics across autologous, allogeneic, and in vivo therapies and critical raw materials, ensuring chain of identity and chain of custody through robust digital systems and quality management. Your work will enable compliant, reliable patient scheduling, collection, and delivery to clinical sites, aligned to manufacturing realities and release windows. You will sit at the center of a connected network spanning manufacturing, clinical, quality, digital, and external partners, aligning operations so the entire enterprise can move faster and smarter. How will you design a logistics operating model that is compliant on day one and scalable for the next wave of indications? Do you thrive in high-stakes, real-time environments where your decisions protect patients and unlock speed at scale?

Requirements

Lead the logistics operations pillar for Cell Therapy, owning the end-to-end operations for scheduling and logistics for autologous, allogeneic, and in vivo cell therapies and critical raw materials.
Ensure compliant, reliable, and scalable vein to vein patient scheduling, collection, and delivery to clinical sites, ensuring COI and COC controls with digital systems and quality management.
Define and evolve the Logistics Operating Model across patient and material flows: slot scheduling, inbound and outbound shipment booking, real-time monitoring, exception management, escalation SLAs, and COI/COC controls.
Align logistics design with manufacturing cycle times, validated hold times, and manufacturing site capacity plans.
Slot allocation and scheduling: Execute and enforce slot management rules to maximize utilization of slots. Lead escalations with Global Planning, Manufacturing, Clinical Development and Commercial Teams.
Quality and compliance: Ensure logistics processes comply with GxP requirements, including COI/COC traceability requirements and internal Quality Management System requirements. Lead/support audits, inspections, CAPAs, and trainings related to logistics. Publish and maintain SOPs, WIs, and playbooks.
Partner with Depot Ops on EU receiving, storage, pick/pack, QP handoffs (GDP); coordinate EU shipment monitoring.
Trade Compliance: Ensure compliant import/export movements, permits/licenses, documentation, and adherence to regional requirements in partnership with Legal/Compliance and customs brokers.
Systems: Define business requirements and UAT for AZ’s cell orchestration platform. Partner with IT to implement digital roadmap that will improve real-time shipment visibility, exception monitoring, and customer experience.
Oversee daily execution performance of logistics for apheresis and drug products, critical materials: order booking, COI/COC traceability, and handoffs to depots/manufacturing. Lead first patient/market hypercares.
Oversee patient scheduling interfaces with clinical sites, collection centers, and manufacturing. Coordinate pickups, customs clearance, and deliveries to meet release windows and validated timelines; manage exceptions and remediations in real time.
Data and Analytics: Set service levels, monitor KPIs. Drive performance through vendor business reviews and continuous improvement.
Exception and Deviation Management: Detect, triage, and resolve shipment exceptions and quality events; lead incident lessons learned and CAPA effectiveness.
Vendor management: Partner with Quality and Procurement to own and enforce courier COPs and qualified lanes (LN2, 2–8 C, OBC), KPIs/QBRs, and vendor RCA/CAPA. Ensure courier performance and execution with proper governance of reviews, problem solving and maintain business continuity.
Risk management and business continuity: Define and maintain lane mapping and run lane risk assessments for patient and material flows. Document route/risk profiles and develop contingency playbooks for logistics disruptions.
Change management: Lead logistics readiness for new indications, new capabilities, new facilities, and other digital or process changes impacting logistics.
Team leadership: Build and lead a high performing logistics operations team. Define clear roles and objectives, develop talent, and foster culture of patient-centricity, compliance, and operational excellence.

Nice To Haves

Experience launching first patient and first market hypercare with cross-functional command centers.
Demonstrated success implementing a digital logistics or cell orchestration platform with measurable gains in visibility and exception resolution.
Depth in EU GDP practices and QP handoffs, including temperature-controlled operations and documentation.
Advanced capability in predictive analytics, lane risk modeling, and KPI design for high-stakes biologics logistics.
Proven leadership building new teams and operating models in fast-growing, highly regulated environments.
Strong background in courier governance across LN2, 2–8 C, and on-board courier lanes, including COPs, QBRs and RCA/CAPA.
Expertise partnering with customs brokers and managing complex import/export licensing for time- and temperature-sensitive therapies.
Continuous improvement credentials such as Lean or Six Sigma applied to clinical and commercial cell therapy logistics.

Responsibilities

Logistics Operating Model: Define and evolve the operating model across patient and material flows to enable scalable, compliant vein-to-vein execution, covering slot scheduling, shipment booking, real-time monitoring, exception management, escalation SLAs, and COI/COC controls. Align design with manufacturing cycle times, validated hold times, and site capacity plans.
Slot Allocation and Scheduling: Execute and enforce slot management rules to maximize utilization and patient access; lead cross-functional escalations with Planning, Manufacturing, Clinical and Commercial to protect priority cases and timelines.
Quality and Compliance: Ensure logistics processes comply with GxP and internal quality system requirements; lead and support audits, inspections, CAPAs, and training; publish and maintain SOPs, work instructions, and playbooks.
EU Depot Operations: Partner with depot teams on EU receiving, storage, pick/pack, QP handoffs and GDP controls; coordinate EU shipment monitoring to safeguard product integrity.
Trade Compliance: Ensure compliant import and export movements, permits and licenses, documentation, and adherence to regional requirements in partnership with Legal, Compliance and customs brokers.
Digital Systems and Orchestration: Define business requirements and UAT for the cell orchestration platform; partner with IT to deliver a roadmap that improves real-time visibility, exception monitoring, and customer experience.
Daily Execution and Patient Interfaces: Oversee day-to-day logistics performance for apheresis, drug product, and critical materials, including order booking, COI/COC traceability, and handoffs to depots and manufacturing; oversee patient scheduling interfaces with clinical sites and collection centers; coordinate pickups, customs clearance, and deliveries to meet release windows; manage exceptions and remediation in real time.
Data and Analytics: Set service levels and monitor KPIs; drive vendor performance through business reviews and continuous improvement to elevate speed, reliability, and patient experience.
Exception and Deviation Management: Detect, triage, and resolve shipment exceptions and quality events; lead incident reviews, lessons learned and CAPA effectiveness to reduce recurrence and systemic risk.
Courier Vendor Leadership: Own courier COPs and qualified lanes (LN2, 2–8 C, OBC), KPIs and QBRs, and vendor RCA/CAPA; ensure consistent performance, governance and business continuity across global lanes.
Risk Management and Business Continuity: Define and maintain lane mapping and lane risk assessments; document route and risk profiles; build contingency playbooks to keep product moving despite disruptions.
Change Management: Lead logistics readiness for new indications, capabilities, facilities, and digital or process changes; ensure smooth transitions without compromising compliance or patient timelines.
People Leadership: Build and lead a high-performing team; define clear roles and objectives, develop talent, and foster a culture of patient-centricity, compliance, and operational excellence.