Qc Manager Biotech - Beerse, België - Johnson & Johnson

Johnson & Johnson

Geverifieerd bedrijf

Beerse, België

2 weken 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 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 onthejob 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.
510 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.