Vein-to-Vein Operations Support Specialist
Location: Beerse, Belgium - Hybrid working - on site 1 day a week
Duration: 6 months
Hours: 40 hours
CAR-T is an advanced therapy that uses the patient's own immune system to fight disease. The patient's T-cells are genetically modified to eliminate cancer cells.
This groundbreaking 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.
Roles and Responsibilities
* 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.
Requirements
* 1-3 years of related experience, including significant experience in pharmaceutical or other highly regulated industries.
* Knowledge of Quality Systems' processes inclusive of cGMP and FDA regulations.
* Experience 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 working in a global and ambiguous setting that is in flux.
* Effective communication skills.
* Constant drive for improvement and innovation.
* Positive can-do mindset when dealing with challenges.
* Strong self-awareness and open to giving/receiving feedback.
Benefits
This role offers a very competitive hourly rate.
This contract will run for 6 months and has a strong chance of extension.