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Sample management coordinator

Beerse
Johnson & Johnson
DJ
Publiée le 10 décembre
Description de l'offre

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Non-Standard Job Sub Function: Workday Associate B Job Category: Non-Standard All Job Posting Locations: Beerse, Antwerp, Belgium Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for a Sample Management Coordinator position for the CAR-T hub in Europe. The position will be based in Beerse, Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and are engineered to eliminate cancer cells expressing a specific antigen. To support the CAR-T program in EMEA, Janssen has built two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site. The Sample Management Coordinator is responsible for the coordination and follow up of sample management including the coordination of Processing Aids, Packaging Materials, Raw Materials, Environmental Monitoring, Release and Retain samples within the CAR-T QC Lab as well as outside the lab. The outside responsibility consists of the coordination of external testing labs, follow up on the daily sample shipments from our manufacturing sites and overseeing the different transport lanes. Employment type: Full-time Reports to: Sample Management Coordinator/Supervisor Backup responsibility: Serve as backup supervisor for the Sample Management Coordinator/Supervisor Purpose: As Sample Management Coordinator you will own the planning and coordination of sampling flows, transportation, receipt, testing and release for multiple sample streams (raw materials, packaging, process materials, floorstock, environmental and release/retained samples). You ensure continuity during bridge days and site closures, manage overflow and disposals, maintain procedures and processes, and coordinate closely with contract laboratories. As a Sample Management Coordinator, you will: Plan and coordinate sampling flows, testing and release for: Raw materials (planning, sampling, testing, release) Packaging / Primary components (PA) Process materials (PM) Floorstock FDP Release and Retain samples Environmental Monitoring samples Critical Reagents Plan transport and receipt for Release/Retained samples and EM samples, including arrangements for bridge days (brugdagen), site closures (sluiting) and daily management (dagelijks beheer). Plan and manage disposal flows for released/discarded samples. Manage overflow of retain samples and put contingency plans in place to avoid testing delays. Manage CHG’s (change requests/changes) related to updates on sample coordination of the scope of samples. Maintain and improve the Tier process (escalation/prioritisation tiers) to ensure timely sample handling. Develop, review and maintain procedures (SOPs) covering all of the above sample streams and activities. Act as backup supervisor for Stijn P when required. Plan and communicate sample schedules and status with contract laboratories and external partners, including but not limited to: Ghent UZ, EUF, ABT, Bioreliance, Eurofins PHAST, Malvern. Provide clear status reporting and KPIs on sample throughput, backlog, temperature excursions and inventory. Support audits and inspections by providing documentation, process clarification and corrective actions when needed. Train and advise internal sites and contractors on correct sample labelling, collection and transportation procedures. Required qualifications & experience Bachelor’s degree in life sciences, chemistry, supply chain, logistics or related field — or equivalent experience. 3 years’ experience in sample management, laboratory logistics, QA/QC or clinical/regulated environment. Proven experience planning sample flows and coordinating with contract labs. Familiarity with LIMS or sample tracking systems. Knowledge of cold-chain logistics and temperature-controlled shipping requirements. Understanding of relevant regulations and standards (GxP/GLP, IATA, local biosafety/shipping rules). Key skills Strong organisational and planning skills with attention to detail. Excellent communication skills in English; Dutch language skills are preferred given local coordination requirements. Proactive problem-solver: able to prioritise and resolve overflow and disruption scenarios. Comfortable creating and updating SOPs and process documentation. Proficient in Excel and familiar with enterprise systems (LIMS/ERP). Able to work cross-functionally with lab teams, QA, QA release, logistics and external partners. Nice-to-have Experience in pharmaceutical/biotech/clinical lab environments. Experience managing change processes (CHG) and Tier escalation frameworks. Experience coordinating with the specific contract labs listed above. At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time. Here’s what you can expect: Application review: We’ll carefully review your CV to see how your skills and experience align with the role. Getting to know you: If there’s a good match, you’ll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have. Staying informed: We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step. Final steps: For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these. Finally, at the end of the process, we’ll invite you to share feedback in a short survey — your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We’re excited to learn more about you and wish you the best of luck in the process! RPOEMEA Required Skills: Preferred Skills: Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Innovation, ISO 9001, Persistence and Tenacity, Problem Solving, Process Oriented, Quality Auditing, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy

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