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Position Title: QC Supervisor Micro Lab, CAR-T Europe

The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QC Supervisor Micro Lab 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 are operated from the Janssen Beerse site.

The QC Supervisor Microbiology oversees the day-to-day planning & Quality Control activities for the QC Micro Release laboratory, ensuring GMP compliance, accuracy and timely release of the micro-related tests performed on the CAR-T drug product. The QC Supervisor Microbiology manages a team of QC analysts and is responsible for interviewing, hiring, performance review, rewarding, disciplining employees, addressing complaints, resolving conflict and supporting internal and external audits. The supervisor carries out these responsibilities in accordance with the organization’s policies as well as with local, state and federal regulations and guidelines (including EMA, FDA, …)

Quality Leadership:

• Lead the Micro QC team (EM lab, Mycoplasma lab, Sterility lab, Growth promotion testing lab and Endotoxin 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

Operational Quality performance:

• Manages a team of QC micro analysts within the QC department based on assigned work, direction, coaching and developing capabilities.
• Sets testing priorities and manages work assignments
• Maintains individual training completion in a compliant state
• Evaluates performance and provides opportunities for growth.
• Communicates department objectives and metrics
• Implements methods and procedures for testing, evaluation and inspection
• Ensures accuracy and completeness of executed analytical method qualification, validation, and transfer activities
• Reviews/approves QC laboratory data for validity and accuracy as QC department subject matter expert (SME) and according to cGMP/cGLP standards
• Supports laboratory investigations of OOS/ invalid assays, CAPAs and change controls
• Maintains detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.
• Collaborates with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance and contract labs to support business needs.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

Experience and Skills:

• A minimum of a Bachelor Degree in Science or equivalent technical discipline is required.
• A minimum of 3-4 years of experience in Quality Control related to manufacturing is required.
• Experience working with cell therapy is preferred
• Experience in method development, cell banking, or Research & Development is preferred
• knowledge of analytical technologies used in a QC micro laboratory and method transfer is preferred (Growth promotion, Sterility, Endotoxin and Mycoplasma testing, environmental monitoring)
• A minimum of one (1) year of supervisory experience is preferred.
• Excellent written and oral communication skills are required.
• 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
• Detailed knowledge of compendial (USP, EP, JP, etc.) requirements and standards for QC testing is required
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint) is required
• Candidates must be able to accommodate a shift schedule (early/late) as required by clinical/commercial demand.

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