To further strengthen our Manufacturing and Supply team, we are looking for a talented Associate Biological Sample Management with strong expertise in the shipment of biological, clinical, and regulated materials. This position offers a unique opportunity to support the build-out and shaping of a global supply chain infrastructure for innovative pharmaceutical and biologics products.
This position requires a daily on-site presence in the office/labs in Zwijnaarde (Ghent, Belgium).
In addition to your CV, we would like to receive a short and clear motivation for this role.
Key Accountabilities and Responsibilities
1. Support the execution of logistics for the research, (non) clinical and commercial supply chain, including biological and temperature-sensitive materials.
2. Manage and oversee sample shipments, including but not limited to human biological material, cell lines, living animals, materials from animal origin, antibodies, proteins, drug substance, and drug product, in compliance with all applicable regulations.
3. Act as primary liaison with Logistics Service Providers, couriers, and freight forwarders for operational execution of argenx logistics activities.
4. Ensure complete, accurate, and compliant shipment documentation (together with couriers), enabling smooth customs clearance for regulated biological materials.
5. Ensure compliance with international and local transport regulations, including cold-chain requirements.
6. Serve as point of contact with regulatory authorities and external agencies for logistics-related permits and approvals, including:Application, coordination, and maintenance of CITES permitsImport/export permits for animal-derived biological materials, through FAVVLiaison with customs, health authorities, and inspection bodies as required
7. Document, investigate, and file shipment deviations, temperature excursions, and quality events in collaboration with Quality Assurance.
8. Support the implementation, qualification, and maintenance of approved logistics lanes, including courier and packaging solutions for biological materials.
9. Maintain a logistics capacity and demand forecast model to support strategic decision-making.
10. Identify, assess, and mitigate logistics-related risks, particularly those related to time-critical and high-risk biological shipments.
11. Manage incoming orders from CROs for delivery of argenx research and non-clinical materials; plan, track, and monitor shipments end-to-end. Store documentation in a centralized database.
12. Identify potential cost savings and efficiency improvements while maintaining compliance and quality.
13. Perform logistics transactions in the ERP system.
14. Maintain logistics performance metrics, including quality, quantity, delivery timelines, transport costs, and efficiency.
15. Contribute to swift issue resolution, root cause analysis, and continuous improvement initiatives.
16. Maintain awareness of global regulatory and compliance changes impacting biological and clinical logistics.
17. Liaise closely with Quality Assurance, Clinical Operations, and external partners on quality- and compliance-related matters.
Profile
Qualifications and skills
18. Demonstrated experience with biological, clinical, and hazardous materials shipments.
19. Solid understanding of cold chain logistics and temperature-controlled transport.
20. High level of quality and compliance awareness.
21. Strong knowledge of GDP and regulated pharmaceutical/biological logistics.
22. Flexible and hands-on mindset, able to manage priorities in a dynamic, fast-growing biotech environment.
23. Excellent communication skills with both internal and external stakeholders.
24. Proactive, solution-oriented, and continuous improvement mindset.
Education and experience
25. Bachelor’s or Master’s degree in Logistics, Supply Chain, Life Sciences, or a related field.
26. Technical expertise in supply chain management, temperature-controlled logistics, and regulated biological shipments.
27. Experience in a pharmaceutical, biotech, or clinical research environment is a strong asset.
28. Familiarity with international shipping regulations for biological and chemical materials is required.
29. Proficient in both English & Dutch communication (both spoken and written) is a mandatory requirement.
30. Available to work daily from the offices/labs in Zwijnaarde (Ghent, Belgium).
Offer
31. A competitive salary package with extensive benefits.
32. Work in a cross-functional, international environment with diverse internal and external stakeholders.
33. A position in a human-sized, dynamic, and rapidly growing biotech company.
34. Opportunity to actively contribute to the build-out of a global commercial and clinical supply chain.
#LI-Onsite