Sample Management Coordinator, Car-t
Il y a 3 mois
CAR-T is an innovative blood cancer treatment that uses the strength of the patient's own immune system. The patient's T-cells are genetically modified to eliminate the cancer cells. This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results.
We are therefore working passionately on expanding our capacity for CAR-T treatments in Europe, both at our existing site in Beerse and in Ghent, where we have developed a new production site. We are looking for strong talents who are eager to participate in this innovative and hopeful venture.
The Innovative Medicine Supply Chain Group, a member of the Johnson & Johnson family of companies, is therefore recruiting a Sample management/planning coordinator for the CAR-T hub in Europe. The position will be based in Beerse Belgium.
The sample mgmt./planning coordinator, CAR-T Europe is responsible for providing logistic oversight and following-up of sample and material flows between the Ghent facility and the Beerse Quality Control laboratory and between the Beerse Quality control and contract labs in accordance with Janssen policies, standards, procedures, and Global cGMP’s.
**Major Responsibilities**:
- Maintain the logistic sample flow of sample receival from the Ghent facility to Beerse QC laboratory ensuring the right temperature conditions, track & trace and timely transport of the different samples. Receive & reconcile samples upon transport.
- Coordination and execution of sample shipments to external test laboratories, as well as acceptance and control of analysis results from external test laboratories in eLIMS.
- Follow up daily transports between the Ghent facility and the Beerse QC laboratory, provide feedback to the Ghent facilities on improvements/issues
- Follow up and organize frequent transports to overflow locations for retain samples
- Work together with the different QC lab supervisors to ensure smooth planning of the different samples and right prioritization.
- Support investigations regarding abnormalities in sample flow/shipping conditions/sample amount/as well as assisting in defining of corrective and preventive measures (CAPA).
- Life-cycle management of relevant SOPs, WIs and Protocols focusing on sample management
- Independent processing and support of local and global projects in the area of sample management.
- Carrying out and documenting temperature evaluations of product shipments.
**Qualifications**:
- A minimum of a bachelor’s degree in Engineering, Science or equivalent technical discipline is required.
- A minimum of 2 years of people management experience is required.
- A minimum of 5 years of experience usage of eLims and/or MD setup is required.
- Knowledge of cGMP regulations and FDA/EU guidance is required.
- High organizational skills and independent and flexible way of working are required.
- Excellent written and oral communication skills are required.
- Professional experience in a GMP-regulated environment, preferably in the area of quality control, is an advantage
- Very good knowledge of using Microsoft Office programs
- Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability._
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