Qc Supervisor Critical Reagents Car-t - Beerse, België - Johnson & Johnson

Johnson & Johnson

Geverifieerd bedrijf

Beerse, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QC Supervisor Critical Reagents 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 is building two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site.

The QC Supervisor CR oversees day-to-day planning and Quality Control activities for the Critical Reagent laboratory, ensuring GMP compliance, accuracy and timeliness of specified testing processes.

The QC Supervisor CR carries out duties in compliance with all local, state and federal regulations and guidelines (including EMA, FDA,...) as well as all company and site policies and procedures.

This position is responsible for carrying out supervisory responsibilities in accordance with the organization's policies and applicable laws.

Responsibilities include interviewing, hiring, performance review, rewarding and disciplining employees, addressing complaints, resolving conflict and supporting internal and external audits.

Quality Leadership

Lead the QC CR team (Flow Cytometry Lab, Molecular Assay Lab, ELISA Lab) by supporting, coaching and developing team members in reaching quality, business and personal objectives
Establish and maintain effective working relationships with business and quality partners to ensure alignment of objectives and deliverables
Proactively and continuously challenge the organizational performance and develop and implement improvements in organizational performance
Manages a team of analysts within the QC department based on assigned work, direction, coaching and developing capabilities.
Set testing priorities and manage work assignments
Maintain individual training completion in a compliant state
Evaluate performance and provides opportunities for growth.
Communicate department objectives and metrics
Implement methods and procedures for testing, evaluation and inspection
Ensure accuracy and completeness of executed analytical method qualification, validation, and transfer activities
Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards
Support laboratory investigation of OOS/ invalid assays, CAPAs and change controls
Maintains detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in onthejob training requirements.
Collaborates with Quality Assurance, Analytical Development, Contract labs and our Partner lab in the US, to support business needs.
Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Qualifications:

A minimum of a Bachelor Degree in Engineering, Science or equivalent technical discipline is required.
A minimum of 35 years of work experience is required
Experience in method development, cell banking, or Research & Development is preferred
A minimum of three (3) years of supervisory experience is preferred.
Expert knowledge of analytical technologies used in a QC laboratory and method transfer is required (Flow, Elisa, qPCR, NC200)
Prior experience in cell and gene therapy is preferred
Prior experience with reagent qualification and reagent management is preferred
Prior experience with LIMs and SAP is preferred
Detailed knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems is required
Experience with ICH Q7 and/or 21 CFR parts 210, 211, 600, 601, and 610 is required