Plant Microbiologist, CAR-T Europe
Johnson & Johnson
Beerse, Antwerp, BE
6 dagen geleden

The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Plant Microbiologist for the CAR-T hub in Europe.

The position will be based in Ghent 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 Plant Microbiologist, CAR-T Europe is responsible for providing microbiological and aseptic oversight and contamination control of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

Major Responsibilities :

  • Work with Process Development team, Quality and Operations organization to successfully transfer process to cGMP facility to manufacture products.
  • Define specific aseptic techniques to be performed for crucial process steps and provide meaningful input to processing operations.
  • Review and approve relevant QC documents, SOP’s and WI’s.
  • Ensure microbiological control strategy is consistent with cGMP and Janssen requirements
  • Set up validation and routine monitoring environmental sampling program
  • Play a lead and proactive role in the design, maintenance and delivery of Operations aseptic technique and microbiology awareness training program.
  • In conjunction with manufacturing help improve training related to microbiological hygiene and contamination prevention.

  • Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program.
  • Actively support process microbiological investigations.
  • Drive strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene.
  • Identify risks and opportunities in relation to contamination control on the shop floor and drive follow up initiatives for improvement in close cooperation with operators, QC and operations management.
  • Periodic review of site trends (Utilities) and support identification of appropriate corrective and preventative actions as required.
  • I.e. critical utilities team).

  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Qualifications

    Experience and Skills :

    Education / Experience : A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required.

    A minimum of 5-10 years within the biological and / or pharmaceutical industry with relevant micro experience related to manufacturing is required, preferably in clinical quality, method development, cell banking, cell therapy, or Research & Development.

    Key Capabilities, Knowledge, and Skills :

  • Aseptic processing in ISO 5 clean room and biosafety cabinets
  • Knowledge of cGMP regulations and FDA / EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices
  • Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
  • Detailed knowledge of the shop floor manufacturing process.
  • Comprehensive knowledge of trending using statistical analysis.
  • The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
  • Good written and verbal communication skills are required.
  • The successful candidate must maintain written records of work in the form of notebooks, technical reports and protocols.
  • Ability to summarize and present results, and experience with team-based collaborations is a must.
  • Are you ready to make an impact?

    If you want to leave your personal mark and be valued for who you are, Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career and that you feel you can bring your whole self to work.

    We provide you an environment to fulfil your career aspirations as well as promoting your physical and mental wellbeing.

    You will receive a competitive compensation and benefits package as well as benefits that can be tailored to what is valuable to you throughout different stages of your life.

    For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.

    Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

    That is why we in The Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential.

    No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means You Belong !

    Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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