Qc Car-t Logistic

Il y a 3 mois

Gent, Belgique Johnson & Johnson Temps plein

Within J&J Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family of Companies, we are recruiting a QC Logistic & Support Manager (M/F/X). The position will be based in Ghent, Belgium.

At J&J Innovative Medicine, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of everyone in it.

J&J Innovative Medicine Supply Chain, a member of Johnson & Johnson's Family, and Legend Biotech USA Inc., have entered a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.

The QC Logistic & Support Manager, CAR-T will oversee, lead and improve:

- Logistic activities between and within the Belgian CAR-T sites.
- Logistic activities to external sites including overflow activities
- QC testing related to Environmental Monitoring samples
- eLims Key user activities
- Lab supply activities
- QC Lean implementation/certification program

Key Responsibilities:

- Responsible for the day to day operations within the logistic and eLims team
- Provide Logistic input for site continuous improvement and remediation efforts. Schedule and manage Logistic tasks associated with these efforts.
- Support and lead Logistic continuous improvement projects.
- Act as liaison for the different Belgian CAR-T sites in support of site improvement projects and strategies.
- Collaborate with functional departments to resolve issues.
- Manage cross-functional projects with many stakeholders.
- Oversee timely completion of Logistic/eLims related investigations, CAPAs and change controls.
- Mentor, train and supervise Logistic and eLims staff
- Evaluate performance and provide opportunities for growth.
- Require mínimal direction to complete tasks, know how to get resources and information from established internal contacts; consult with supervisor for decisions outside of established processes.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Other duties will be assigned, as necessary.

**Qualifications**:
Education, experience and Skills:

- A minimum of a Master Degree in Science, Engineering or equivalent experience is required.
- Experience leading, coaching, or supervising direct or indirect personnel or teams
- Strong communication and interpersonal skills, a high level of organizational ability, attention to detail, and ability to work effectively in a collaborative environment globally (US and EU) is required.
- Proficient knowledge of analytical technologies used in a Quality Control laboratory
- Experience working with Quality Systems
- Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the Quality control and ability to identify/remediate gaps in processes or systems is required
- Good written and verbal communication skills
- Knowledge of Good Tissue Practice and experience with cell-based manufacturing is preferred
- Experience with LIMs and SAP or equivalent systems is preferred
- Lean Green/Black belt Certification is preferred

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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