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Your mission
BULK DRUG SUBSTANCE / BULK DRUG PRODUCT / IMP SUPPLY CHAIN MANAGEMENT
- Logistical management of the supply chain
- Oversee and manage the BDS and BDP international shipments and inventory by coordinating with CMOs and CPO (Contract Packaging Organization)
- Responsible for maintaining inventories across GMP components
- Oversee vendors´ inventory system (e.g., CPO´s dedicated systems)
- Oversee and manage IMP shipments to site in collaboration with internal Labelling and Packaging lead / PM, internal Clinical Operations team and external CPOs
- Take responsibility as IoR for international shipping
- Support timelines shipment of intermediates across the network of GMP suppliers; coordinate with internal area leads and internal and CMO´s project managers
- Oversee and manage controlled shipments to license partners
- Contribute to evaluating shipment exceptions / excursions and deviations in collaboration with QA and internal SMEs
- Lead aspects of Labelling and Packaging activities such distribution planning
- Conduct IMP reconciliation in collaboration with Clinical Operations
- Oversee and manage the complete lifecycle of biospecimens (blood and tissue samples) collected for clinical studies
- Responsible for biospecimen management-related activities such as overseeing sample processing documentation and query / deviation reporting
- Responsible for performing routine management activities, such as creating and maintaining inventory files to facilitate specimen tracking using various tracking tools
- Prepare communication plans to enable study leads to deliver samples to appropriate analysis vendors on time, and to follow up on active issues with vendors
- Collaborate with Clinical Operations, Project Management and Quality in the selection of central laboratories, e.g., biospecimen and clinical sample long-term storage
- Identify biospecimen-related risks and mitigation strategy proposals
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