Janssen Pharmaceutical, a member of Johnson & Johnson'sFamily of Companies, is recruiting for a Principal Plant Microbiologist, CAR-
T Manufacturing . The position will be located in Raritan, NJ.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives.
We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Principal Plant Microbiologist, CAR-T Manufacturing is responsible for microbiological oversight and contamination control of the production of autologous CAR-
T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
Responsibilities include but are not limited to :
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.
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.
Other duties will be assigned, as necessary.
A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required
A minimum of 10 years of experience in Quality Assurance related to manufacturing is required.
Experience in clinical quality, method development, cell banking, or Research & Development is preferred.
Experience working with cell therapy is preferred.
Recent microbiology experience related to manufacturing is required.
Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
Knowledge of cGMP regulations and FDA / EU guidance related to manufacturing of cell based products as well as knowledge of Good Tissue Practices is required.
Comprehensive knowledge of trending using statistical analysis is preferred.
Good written and verbal communication skills are required.
This position will require occasional travel to Malvern, PA or Spring House, PA as business demands.
Candidates must be able to accommodate working outside normal business hours (including nights and weekends) on little to no prior notice.
Do you strive to join an outstanding team that is dynamic and ever-changing? Is career growth and opportunity appealing to you?
Apply to this opportunity today.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.