At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at
Job Function:
Non-StandardJob Sub Function:
Workday Associate BJob Category:
Non-StandardAll Job Posting Locations:
Beerse Antwerp BelgiumJob 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.
CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells which work by harnessing the power of a patients 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 CHGs (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
Bachelors 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.
Heres what you can expect:
Finally at the end of the process well 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. Were 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 SavvyRequired Experience:
IC
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more