V2V Operations Support

il y a 2 semaines

Beerse, Flandre, Belgique Arcadis Temps plein

V2V Operations Support

CAR-T is an advanced therapy that uses the patient's own immune system to fight the disease. The patient's T-cells are genetically modified to eliminate cancer cells. This groundbreaking, innovative technology offers a hopeful outlook to patients for whom other therapies have no or insufficient effect. The Vein-to-Vein organization is a global team focused on enhancing the patient journey for cell therapies through effective planning and logistics support. The structure includes regional sub-teams working collaboratively to ensure the efficient, timely, and compliant transport of patient cells across various supply chain nodes.

The V2V Operations Support is responsible for supporting logistics and planning processes, ensuring compliance with Chain of Custody (CoC) and Chain of Identity (CoI) standards for the clients products.

The duties include:

  • Coordinating scheduling, managing the arrival and departure of materials, and addressing any communication issues that may arise. Acting as the primary supply chain contact for a designated group of treatment sites, collaborating closely with commercial teams to ensure a seamless and positive experience throughout the patient journey.
  • Serve as the primary supply chain point of contact for treatment sites and commercial teams within a designated country or region, focusing on logistics, planning, and forecasting · Facilitate the movement of patient materials across the V2V supply chain for EMEA patients.
  • Issue management and non-conformance handling · Manage the inbound and outbound logistics of patient materials, communicating effectively with our carrier network and providing forecasts as needed · Coordinate with internal warehouses and distribution centers to ensure seamless patient journeys · Ensure compliance with Chain of Custody (CoC) and Chain of Identity (CoI) requirements, both in manual and automated processes for clinical and commercial operations
  • Assist in the planning of operational capacity by scheduling and communicating cryopreservation and manufacturing slots
  • Support treatment site certification efforts, including training and conducting logistics test runs
  • Develop Standard Operating Procedures (SOPs) and Work Instructions (WIs) while focusing on process improvement
  • Participate in the development, testing, and rollout of new system solutions
  • Develop and track key performance metrics to assess efficiency and effectiveness

Experience:

  • 1-3 years of related experience, including significant experience in pharmaceutical or other related highly regulated industry
  • Knowledge of Quality Systems' processes inclusive of cGMP and FDA regulations ·
  • Experience is working in SAP is a plus
  • Aptitude to comprehend, analyze and interpret process and systems information, technical procedures, reports, and regulations to make decisions in a GMP environment
  • Proven ability to perform independent work requiring attention to detail, accuracy, and scientific judgment · Comfortable to work in a global and ambiguous setting that is in flux
  • Effective communication skills (candid, concise, active listening)
  • Constant drive for improvement and innovation
  • Positive can-do mindset when dealing with challenges
  • Strong self-awareness & open for giving/receiving feedback

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