Codera
11 - 50 employees
🧬 Biotechnology
💊 Pharmaceuticals
🤝 B2B
Biotechnology • Pharmaceuticals • B2B
Codera is a B2B company that partners with biotechnology and pharmaceutical companies to provide end-to-end drug development expertise and infrastructure. It supports clients across the drug development lifecycle with technical, operational, and infrastructure services to help advance therapeutic programs.
Associate Director – Clinical Supply Chain
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Codera
11 - 50 employees
🧬 Biotechnology
💊 Pharmaceuticals
🤝 B2B
Biotechnology • Pharmaceuticals • B2B
Codera is a B2B company that partners with biotechnology and pharmaceutical companies to provide end-to-end drug development expertise and infrastructure. It supports clients across the drug development lifecycle with technical, operational, and infrastructure services to help advance therapeutic programs.
📋 Description
• Lead end-to-end clinical supply chain operations for assigned international studies • Serve as the primary clinical supply chain contact for assigned studies • Provide study- and site-level operational support, including resupply requests facilitation, returns and destruction oversight, and temperature excursion management • Develop and execute global inventory supply plans in coordination with Technical Operations, Clinical Operations and Quality Assurance • Lead label development efforts for assigned studies, including booklet label development for international studies • Manage manual and IRT-enabled drug supply shipments • Facilitate and oversee storage, returns, reconciliation and destruction • Monitor inventory levels, drug product expirations and resupplies • Oversee import/export licenses and customs forms • Ensure batch release dates are properly prioritized for key study timelines • Review and approve packaging and labeling documents and batch records • Prepare and manage clinical supply projections • Maintain budget for supply chain operations for assigned studies and review and track monthly invoices from vendors against budget • Ensure clinical supply documentation is organized and filed to the Trial Master File (TMF), per SOPs • Participate in inspection readiness efforts, ensuring clinical supply chain is prepared for qualifications
🎯 Requirements
• Bachelor’s Degree required • Minimum 6 years of experience in clinical supply management and logistics within pharmaceutical industry required • Experience with EU/international clinical studies required • Experience with clinical blinding practices in clinical studies preferred • Proficient in GxP and pharmaceutical industry procedures and regulations • Understanding of systems selection, design and management • Strong organizational skills with the ability to manage projects, resources, timelines and budgets, in a fast-paced environment • Must be proficient in Microsoft Excel
🏖️ Benefits
• employer sponsored insurance plans including medical, dental and vision coverage • generous paid time off • retirement plan options • additional wellness and professional development programs
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