Qc Manager Biotech
il y a 6 jours
The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Manager Quality Control Biotech for the CAR-T manufacturing processes in EMEA. The position will be based in Beerse Belgium.
CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eradicating 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 eradicate 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 Manager Quality Control Biotech, CAR-T Manufacturing is accountable for the implementation and execution of the Quality Control programs for CAR-T. The Manager Quality Control is responsible for the timely release testing of the CAR-T product manufacturing in the Ghent facilities.
- Quality Leadership:
- Lead the Quality Control Biotech team 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 people leaders and technical professionals within the QC department based on assigned work, direction, coaching and developing capabilities.
- Responsible for test method verification, qualification and/or transfer activities in the QC Biotech laboratories
- Provides expertise in troubleshooting of complex laboratory issues and demonstrates strong reasoning skills in support of ongoing laboratory investigations.
- 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 to support business needs.
- Contributes to global strategies related to the QC laboratories which align with compliance and business objects as well as the overall J&J vision.
- Manages departmental budget and resources; prepares staffing plans. Makes adjustments to roles and responsibilities of department to meet business needs.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
**Qualifications**:
- A minimum of a Master Degree in Engineering, Science or equivalent technical discipline is required.
- 5-10 years of experience in Quality Control or Analytical Development is required.
- People management or leadership experience is required.
- Experience working with Quality systems is required.
- Experience with Quality support in clinical manufacture or NPI is preferred.
- Extensive knowledge of chemical, biochemical and microbiological concepts is required.
- Experience in clinical quality, method development, cell therapy, or Research & Development is preferred.
- Knowledge of cGMP regulations and FDA/EU guidance is required.
- Comfortable with speaking and interacting with inspectors.
- Good written and verbal communication skills are required.
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