QA CAR-T Manager Plant Microbiologist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

As guided by Our Credo Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Gent East Flanders Belgium

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at & Johnson Janssen Pharmaceutica NV is recruiting for a QA CAR-T Manager Plant Microbiologist CAR-T Europe

Johnson & Johnson EMEA CAR-T is recruiting a QA CAR-T Manager 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 patients 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 J&J has constructed two CAR-T manufacturing centres in the Ghent area (Belgium). The QC laboratories are operating from the existing J&J Beerse site.

The QA CAR-T Manager Plant Microbiologist is responsible for providing microbiologicaland aseptic oversightand contamination controlof theproduction of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

The responsibilities and the impact YOU will have:

Lead and coordinate plant microbiology and aseptic-control activities across ensure product and process microbiological control coach and align teams and drive contaminationrisk reduction and continuous improvement.

Key responsibilities

• Provide technical and leadership oversight for plant microbiology and asepticcontrol activities across sites to ensure robust product and process microbiological control.
• Ensure the contamination control strategy complies with cGMP and J&J/Janssen internal requirements.
• Act as an experienced people managerseeking team input and fostering autonomy. Foster crosssite alignment and a one voice approach within QA Micro; safeguard collaboration and consistent ways of working across sites. Responsible for maintaining team harmony and engagement.
• Establish validate and maintain environmental monitoring programs (validation and routine sampling); periodically reevaluate and communicate key inputs and trends.
• Review and approve relevant QC documentation SOPs and work instructions.
• Lead and support microbiological investigations and rootcause analyses; drive corrective and preventive actions in collaboration with operators QC and operations management.
• Identify contamination risks and opportunities on the shop floor and lead followup improvement initiatives.
• Define aseptic techniques for critical process steps and provide operational input during process transfer and routine production.
• Design maintain and deliver aseptic techniques and microbiologyawareness training and qualification for Operations; support QA Micro trainers and training planning.
• Lead or support sitewide and crosssite projects (e.g. implementation of global standards APS strategy); manage stakeholders and support escalations.
• Perform all tasks in accordance with safety policies quality systems and cGMP requirements.

We would love to hear from YOU if you have the following essential requirements:

• Bachelors degree in Engineering Life Sciences or equivalent technical discipline required; advanced degree desirable.
• 510 years experience in the biological and/or pharmaceutical industry with relevant people leadership and microbiology experience related to manufacturing; experience in cell therapy parenteral production or clinical/commercial quality is preferred.
• Must be fluent in Dutch and English (both written and spoken).
• Demonstrated experience as a people leader in a regulated manufacturing environment.
• Handson knowledge of aseptic processing in ISO 5 cleanrooms and biosafety cabinets.
• Strong knowledge of cGMP regulations and FDA/EU guidance applicable to cellbased products and Good Tissue Practices.
• Indepth knowledge of routine and nonroutine microbiological testing and sampling methods and related equipment.
• Detailed understanding of shopfloor manufacturing processes and critical utilities.
• Proven ability to analyze trends using statistical methods and to present findings clearly.
• Excellent written and verbal communication skills; strong documentation practices (technical reports notebooks protocols).
• Ability to work effectively in crossfunctional teams and to influence stakeholders at multiple levels.
• Demonstrates an understanding of AI concepts and frameworks including awareness of responsible and ethical AI practices and has experience generating effective prompts to boost efficiency and productivity.

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.

#SCQuality

#SCOperator

#SCEngineer

Required Skills:

Preferred Skills:

Business Alignment Coaching Collaboration Compliance Management Continuous Improvement Fact-Based Decision Making Good Manufacturing Practices (GMP) ISO 9001 Process Improvements Quality Control (QC) Quality Management Systems (QMS) Quality Standards Quality Validation Regulatory Environment Standard Operating Procedure (SOP) Tactical Thinking Technical Credibility

The anticipated base pay range for this position is:

79800.00 - 137770.00

Benefits:

In addition to base pay we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Required Experience:

Manager

Employment Type : Full-Time
Experience: years
Vacancy: 1
Monthly Salary Salary: 79800 - 137770