Logistics and planning processes operations support- contractor role
Work location - Beerse onsite 5 days a week required
Vein to Vein 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.
DUTIES & RESPONSIBILITIES
* 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 our 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 Minimum Qualification
EXPERIENCE AND EDUCATION
* 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
Offer:
You can fill this position through Randstad Professionals as a consultant (with an employee contract)
In return for your performance and flexibility, we offer you a salary package with some interesting extras, such as
* Gross salary according to your experience
* Lunch vouchers of €7 per day worked
* Net remuneration of €80 per month
* Company car with fuel card (subject to conditions) or Mileage allowance
* Hospitalisation insurance
* 1 extra day's holiday per month worked
* End of year bonus
* Pension Plan
* ECO vouchers worth €250 (on an annual basis, pro rata)
* Training opportunities