QC Shift Lead Weekend Biotech in Beerse, Belgium

The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QC Shiftlead Weekend Biotech 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 Shiftlead Weekend Biotech oversees day-to-day planning and Quality Control activities for the Biotech Release laboratory during the weekend shift, ensuring GMP compliance, accuracy and timeliness of specified testing processes and managing a team of QC analysts. In addition, the QC Shiftlead Weekend Biotech is responsible for preparing and conducting testing of the different samples taken during the production. The QC Shiftlead Weekend Biotech carries out all above mentioned tasks in compliance with all local, state and federal GMP regulations and guidelines (including EMA, FDA, …) as well as all company and site policies, procedures and standards.

This position is responsible for carrying out supervisory and executive 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, conducting testing and data review and supporting internal and external audits if needed.

Quality Leadership:

• Lead the weekend QC Biotech team (Flow Cytometry Lab, Molecular Assay qPCR 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

• Be the SPOC during the weekend shift

Operational Quality performance and major responsibilities:

• 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

• Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards

• Author/update and review/approve SOPs, WIs and Protocols to support daily operations of the lab using the Document Management System

• 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 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.

• Perform analytical testing in compliance with all applicable specifications, procedures, GMP regulations

• Maintain a safe work environment in compliance with all applicable environmental, health, and safety regulations

• Perform peer review of laboratory data

Qualifications

Experience and Skills:

• A minimum of a Bachelor Degree in Engineering, Science or equivalent technical discipline is required.

• A minimum of 3-5 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 cytometry, ELISA, qPCR, NC200, cell culture)

• 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

• 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 weekend shift schedule.