Associate Biological Clinical Sample Management

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets led by VYVGART our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company our partnerships our science and our people because when we do we deliver more for patients.

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

• Support the execution of logistics for the research (non) clinical and commercial supply chain including biological and temperature-sensitive materials.
• Manage and oversee sample shipments including but not limited to human biological material cell lines living animalsmaterials from animal origin antibodies proteins drug substance and drug product in compliance with all applicable regulations.
• Act as primary liaison with Logistics Service Providers couriers and freight forwarders for operational execution of argenx logistics activities.
• Ensure complete accurate and compliant shipment documentation (together with couriers) enabling smooth customs clearance for regulated biological materials.
• Ensure compliance with international and local transport regulations including cold-chain requirements.
• Serve as point of contact with regulatory authorities and external agencies for logistics-related permits and approvals including:
  • Application coordination and maintenance of CITES permits
  • Import/export permits for animal-derived biological materials through FAVV
  • Liaison with customs health authorities and inspection bodies as required
    
• Document investigate and file shipment deviations temperature excursions and quality events in collaboration with Quality Assurance.
• Support the implementation qualification and maintenance of approved logistics lanes including courier and packaging solutions for biological materials.
• Maintain a logistics capacity and demand forecast model to support strategic decision-making.
• Identify assess and mitigate logistics-related risks particularly those related to time-critical and high-risk biological shipments.
• 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.
• Identify potential cost savings and efficiency improvements while maintaining compliance and quality.
• Perform logistics transactions in the ERP system.
• Maintain logistics performance metrics including quality quantity delivery timelines transport costs and efficiency.
• Contribute to swift issue resolution root cause analysis and continuous improvement initiatives.
• Maintain awareness of global regulatory and compliance changes impacting biological and clinical logistics.
• Liaise closely with Quality Assurance Clinical Operations and external partners on quality- and compliance-related matters.

Profile

Qualifications and skills

• Demonstrated experience with biological clinical and hazardous materials shipments.
• Solid understanding of cold chain logistics and temperature-controlled transport.
• High level of quality and compliance awareness.
• Strong knowledge of GDP and regulated pharmaceutical/biological logistics.
• Flexible and hands-on mindset able to manage priorities in a dynamic fast-growing biotech environment.
• Excellent communication skills with both internal and external stakeholders.
• Proactive solution-oriented and continuous improvement mindset.

Education and experience

• Bachelors or Masters degree in Logistics Supply Chain Life Sciences or a related field.
• Technical expertise in supply chain management temperature-controlled logistics and regulated biological shipments.
• Experience in a pharmaceutical biotech or clinical research environment is a strong asset.
• Familiarity with international shipping regulations for biological and chemical materials is required.
• Proficient in both English & Dutch communication (both spoken and written) is a mandatory requirement.
• Available to work daily from the offices/labs in Zwijnaarde (Ghent Belgium).

Offer

• A competitive salary package with extensive benefits.
• Work in a cross-functional international environment with diverse internal and external stakeholders.
• A position in a human-sized dynamic and rapidly growing biotech company.
• Opportunity to actively contribute to the build-out of a global commercial and clinical supply chain.
  

#LI-Onsite

At argenx all applicants are welcomed in an inclusive environment. They will receive equal consideration for employment without discrimination on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other applicable legally protected characteristics. argenx is proud to be an equal opportunity employer.

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