QA Micro Supervisor TechLane

at  Johnson Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
CAR-T is an innovative blood cancer treatment that uses the strength of the patient’s own immune system. The patient’s T-cells are genetically modified to eliminate the cancer cells. This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results.
We are therefore working passionately on expanding our capacity for CAR-T treatments in Europe, both at our existing site in Beerse and in Ghent, where we are developing a new production site.
We are looking for strong talents who are eager to participate in this innovative and hopeful venture.
The QA Micro Supervisor, CAR-T Europe is part of a team 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. The QA Micro Supervisor will be based in Ghent, Belgium and reports to the site’s Plant Microbiologist.

Major Responsibilities:

• Lead a team of 4-8 FTE that ensures contamination control of the facility to manufacture products, consistent with cGMP and Janssen requirements and in collaboration with Quality Assurance/Control, Operations and MS&T organizations.
• Drive strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene.
• Owns aseptic qualification program of manufacturing personnel (e.g. gowning, aseptic processing).
• Drives the Aseptic Oversight program by ensuring manufacturing floor surveillance.
• Reviews and approves process microbiological investigations at the manufacturing site.
• Define specific aseptic techniques to be performed for crucial process steps through instructor-led trainings and awareness sessions.
• Write relevant QC documents, SOP’s and WI’s.
• Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program.
• Identify risks and opportunities in relation to contamination control and assist in follow-up initiatives for improvement in close cooperation with operators, QC and operations management.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

QUALIFICATIONS

Education/Experience:
A Master’s Degree in Engineering, Science or equivalent technical discipline is required. A minimum of 5 years experience within the biological and/or pharmaceutical industry is required, preferably with relevant micro experience in manufacturing, 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.
• Experience in people leadership is preferred.
• Detailed knowledge of the shop floor manufacturing process.
• 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
• You like to explore new paths, to make full use of your knowledge and experience, as well as to expand it, so that new problems also get solutions.
• You see possibilities and you look for them, even when they are not immediately clear.
• You like to work in a team towards a common goal.
• You consider diversity an asset.
• You can deal with procedures and guidelines that require strict application, as well as situations where not everything is clear yet.

Our offer

• The opportunity to participate in a progressive treatment that gives hope to patients in need.
• Being able to help shape a new venture from the start.
• An innovative working environment.
• Training on the job for this specific treatment.
• Opportunities to continue to develop and grow in an extensive and strong organization.

Location: Ghent, site TechLane
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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

• Lead a team of 4-8 FTE that ensures contamination control of the facility to manufacture products, consistent with cGMP and Janssen requirements and in collaboration with Quality Assurance/Control, Operations and MS&T organizations.
• Drive strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene.
• Owns aseptic qualification program of manufacturing personnel (e.g. gowning, aseptic processing).
• Drives the Aseptic Oversight program by ensuring manufacturing floor surveillance.
• Reviews and approves process microbiological investigations at the manufacturing site.
• Define specific aseptic techniques to be performed for crucial process steps through instructor-led trainings and awareness sessions.
• Write relevant QC documents, SOP’s and WI’s.
• Maintain, re-evaluate and communicate key critical inputs to site environmental monitoring program.
• Identify risks and opportunities in relation to contamination control and assist in follow-up initiatives for improvement in close cooperation with operators, QC and operations management.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements