Overview
In this role you will manage end-to-end clinical cell therapy logistics, ensuring timely, compliant delivery of products for pivotal trials. You’ll coordinate enrollment readiness, apheresis, manufacturing tracking, and final product delivery, working with trial sites, CROs, 3PLs, and manufacturing teams. You will uphold chain of identity and custody, monitor shipments, and proactively resolve issues to support patient treatment timelines. The position offers cross-functional collaboration in a fast-paced environment and exposure to global regulatory and supply chain processes. This is an opportunity to help enable life-changing therapies at a leading biopharma company.
Pay / Benefits
- flexible working policy
- two days remote work
- three days onsite
- opportunity to contribute to life-changing therapies
- collaboration with CROs and manufacturing units
- access to global regulatory and supply chain expertise
Responsibilities
- End-to-end cell journey execution and enrollment readiness coordination
- Manage apheresis coordination and transport of cellular material to manufacturing
- Track shipments, customs, and product status; communicate delivery expectations to sites and SMT
- Maintain CoI/CoC documentation and ensure traceability across systems
- Book and verify cell orders in ERP; manage supply orders including shipper kits and LN2 dewars
- Coordinate with manufacturing, QA, Site Planning, and QA Product disposition to enable timely IP release
- Participate in Study Management Team meetings and provide IP delivery updates
- Serve as day-to-day logistics POC for trial sites, CROs, and internal stakeholders
- Participate in 24/7 on-call rotation for time-critical logistics events
- Ensure compliance with SOPs, eTMF, and regulatory requirements
Key requirements
- Experience in clinical logistics, clinical operations, or clinical supply chain in biopharma
- Basic understanding of end-to-end clinical trial operations and site-level logistics
- Knowledge of cold-chain logistics or temperature-controlled biologics a plus
- Experience with ERP systems (e.g., SAP, EBS) and clinical trial tools (CTMS, EDC, eTMF, IRT, IXRS)
- Familiarity with DCS and QMS systems (Veeva, Agile)
- Basic knowledge of GCP, GMP, GxP, ICH, IATA principles and regulatory requirements
- Excellent communication and collaboration skills
- Ability to manage complexity and multiple priorities in a fast-paced environment
- Proficiency with Microsoft Office, SharePoint, Smartsheet, and related systems
- Excellent communication
- Collaborative mindset
- Strong problem-solving abilities
- Salesforce (cell journey orchestration platform)
- ERP systems (SAP, EBS)
- 3PL coordination and systems
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