Job Description
Location: Gaithersburg, MD or Tarzana, CA
Hybrid Schedule: 3 days onsite, 2 days remote
Duration: 6 months
In AstraZeneca's Cell Therapy division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. We have the potential to grow our pipeline and positively impact the lives of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. This role is part of the Cell Therapy Supply Chain team tasked with supporting critical development of supply chain logistics capability and process. We ask that you plan, escalate issues to ensure successful project delivery.
Summary:
The Senior Specialist (Logistics Coordinator) supports end‑to‑end vein‑to‑vein (V2V) logistics for cell therapy trials, executing slot scheduling, shipment booking, real‑time shipment monitoring, and exception management. The role ensures chain of identity/chain of custody (COI/COC), cold‑chain compliance, and timely, accurate system updates. Works closely with the Associate Director, Cell Therapy Logistics Operations and cross‑functional teams to meet patient scheduling and delivery timelines.
Key Responsibilities:
• V2V execution and tracking: Coordinate apheresis collections, manufacturing slot reservations, and IMP/starting‑material shipments; maintain traceability and milestone status in cell orchestration platforms and courier portals.
• Slot scheduling: Reserve, confirm, and adjust manufacturing and collection slots per study rules and capacity; communicate changes to sites and internal teams; uphold slot guardrails and escalation paths.
• Shipment booking and monitoring: Book temperature‑controlled shipments (LN2, 2–8 °C, ambient, OBC); prepare/verify documentation; monitor real‑time status; drive on‑time pickup/delivery.
• Exception and deviation management: Triage delays, temperature excursions, and customs holds; execute contingency plans; document events; support investigations/CAPAs with Quality.
• COI/COC and compliance: Ensure end‑to‑end COI/COC controls, GDP/GxP adherence, and audit‑ready records (labels, logs, proof of delivery, temperature data).
• Vendor/courier coordination: Interface daily with specialty couriers/LSPs on lane performance, booking accuracy, and recoveries; capture KPIs and issues.
• Cross‑functional communication: Provide concise status to Clinical Ops, Manufacturing/Tech Ops, Trade Compliance, and sites; support study meetings as needed.
• Reporting and analytics: Maintain dashboards/KPIs (slot utilization, OTD, excursion rate, cycle times); perform basic trend analysis; contribute to weekly readouts.
• Documentation and SOPs: Follow current SOPs/WIs; contribute updates to work instructions, shipping guides, and site handling manuals; support UAT for system enhancements.
Qualifications:
Education: BS/BA in Supply Chain, Life Sciences, Engineering, or related field (or equivalent experience).
Experience:
• 5+ years in biopharma clinical logistics/supply chain with cell therapy V2V experience strongly preferred; hands‑on cold‑chain and COI/COC execution.
• Technical skills: Proficiency with cell orchestration platforms and courier/LSP portals; Excel (pivot tables, lookups; macros a plus); Power BI/Tableau or Smartsheet; familiarity with global trade compliance and deviation/quality systems.
• Operations: Strong attention to detail, documentation accuracy, and follow‑through; ability to manage multiple shipments/slots across time zones and support off‑hours when required.
• Communication & collaboration: Clear, crisp communicator; effective with sites, vendors, and internal stakeholders; capable of structured problem solving under time pressure.
Core Competencies:
• Patient focus and integrity: Centers decisions on patient impact; safeguards COI/COC and data integrity per GxP/GDP.
• Delivery excellence: Executes V2V logistics reliably (slot scheduling, shipment booking, monitoring) and meets service levels under time pressure.
• Problem solving and judgment: Anticipates risks, triages exceptions, and applies sound judgment to recover shipments and protect timelines.
• Collaboration and influence: Works seamlessly with sites, couriers, Tech Ops/Manufacturing, Quality, and Trade Compliance; influences without authority to align actions.
• Data and digital enablement: Maintains accurate milestones; uses dashboards/KPIs to spot trends and drive corrective actions; proficient in cell orchestration and courier portals.
• Continuous improvement: Identifies waste/bottlenecks; proposes practical changes that reduce cycle time, reschedules, and excursions.
• Planning and prioritization: Balances parallel shipments and slot changes across time zones; adapts to shifting priorities while maintaining documentation rigor.
• Compliance awareness: Applies global trade and regional shipment requirements at an operational level (documentation readiness, broker coordination) without acting as the primary trade compliance specialist.
Hybrid Schedule: 3 days onsite, 2 days remote
Duration: 6 months
In AstraZeneca's Cell Therapy division, we follow the science to explore and innovate. We are working towards treating, preventing, modifying, and even curing some of the world's most complex diseases. We have the potential to grow our pipeline and positively impact the lives of patients around the world. We are committed to making a difference and have built our business around our passion for science. Now we are fusing data and technology with the latest scientific innovations to achieve the next wave of breakthroughs. This role is part of the Cell Therapy Supply Chain team tasked with supporting critical development of supply chain logistics capability and process. We ask that you plan, escalate issues to ensure successful project delivery.
Summary:
The Senior Specialist (Logistics Coordinator) supports end‑to‑end vein‑to‑vein (V2V) logistics for cell therapy trials, executing slot scheduling, shipment booking, real‑time shipment monitoring, and exception management. The role ensures chain of identity/chain of custody (COI/COC), cold‑chain compliance, and timely, accurate system updates. Works closely with the Associate Director, Cell Therapy Logistics Operations and cross‑functional teams to meet patient scheduling and delivery timelines.
Key Responsibilities:
• V2V execution and tracking: Coordinate apheresis collections, manufacturing slot reservations, and IMP/starting‑material shipments; maintain traceability and milestone status in cell orchestration platforms and courier portals.
• Slot scheduling: Reserve, confirm, and adjust manufacturing and collection slots per study rules and capacity; communicate changes to sites and internal teams; uphold slot guardrails and escalation paths.
• Shipment booking and monitoring: Book temperature‑controlled shipments (LN2, 2–8 °C, ambient, OBC); prepare/verify documentation; monitor real‑time status; drive on‑time pickup/delivery.
• Exception and deviation management: Triage delays, temperature excursions, and customs holds; execute contingency plans; document events; support investigations/CAPAs with Quality.
• COI/COC and compliance: Ensure end‑to‑end COI/COC controls, GDP/GxP adherence, and audit‑ready records (labels, logs, proof of delivery, temperature data).
• Vendor/courier coordination: Interface daily with specialty couriers/LSPs on lane performance, booking accuracy, and recoveries; capture KPIs and issues.
• Cross‑functional communication: Provide concise status to Clinical Ops, Manufacturing/Tech Ops, Trade Compliance, and sites; support study meetings as needed.
• Reporting and analytics: Maintain dashboards/KPIs (slot utilization, OTD, excursion rate, cycle times); perform basic trend analysis; contribute to weekly readouts.
• Documentation and SOPs: Follow current SOPs/WIs; contribute updates to work instructions, shipping guides, and site handling manuals; support UAT for system enhancements.
Qualifications:
Education: BS/BA in Supply Chain, Life Sciences, Engineering, or related field (or equivalent experience).
Experience:
• 5+ years in biopharma clinical logistics/supply chain with cell therapy V2V experience strongly preferred; hands‑on cold‑chain and COI/COC execution.
• Technical skills: Proficiency with cell orchestration platforms and courier/LSP portals; Excel (pivot tables, lookups; macros a plus); Power BI/Tableau or Smartsheet; familiarity with global trade compliance and deviation/quality systems.
• Operations: Strong attention to detail, documentation accuracy, and follow‑through; ability to manage multiple shipments/slots across time zones and support off‑hours when required.
• Communication & collaboration: Clear, crisp communicator; effective with sites, vendors, and internal stakeholders; capable of structured problem solving under time pressure.
Core Competencies:
• Patient focus and integrity: Centers decisions on patient impact; safeguards COI/COC and data integrity per GxP/GDP.
• Delivery excellence: Executes V2V logistics reliably (slot scheduling, shipment booking, monitoring) and meets service levels under time pressure.
• Problem solving and judgment: Anticipates risks, triages exceptions, and applies sound judgment to recover shipments and protect timelines.
• Collaboration and influence: Works seamlessly with sites, couriers, Tech Ops/Manufacturing, Quality, and Trade Compliance; influences without authority to align actions.
• Data and digital enablement: Maintains accurate milestones; uses dashboards/KPIs to spot trends and drive corrective actions; proficient in cell orchestration and courier portals.
• Continuous improvement: Identifies waste/bottlenecks; proposes practical changes that reduce cycle time, reschedules, and excursions.
• Planning and prioritization: Balances parallel shipments and slot changes across time zones; adapts to shifting priorities while maintaining documentation rigor.
• Compliance awareness: Applies global trade and regional shipment requirements at an operational level (documentation readiness, broker coordination) without acting as the primary trade compliance specialist.
💡 Quick Summary
Seeking a career-building opportunity? The Sr Specialist, Cell Therapy Logistics Coordinator position is now open for candidates interested in the Health Jobs sector. This role in Los Angeles offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Health Jobs is a plus.
