Johnson & Johnson Careers

Quality Manager, CAR-T Manufacturing

Raritan, New Jersey
Quality Assurance


Job Description

Requisition ID: 8138180807

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Manager, 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 Quality Manager, CAR-T Manufacturing is responsible for oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.  Job duties are performed within a team according to an assigned, production shift schedule. 


Responsibilities include but are not limited to:
  • Work with Process Development team and Operations organization to successfully transfer process to cGMP facility to manufacture products. 
  • Lead operational quality team, directing initiatives that accomplish continuous improvement and cost effectiveness and enhance efficiencies and compliance of processes and procedures.
  • Oversee batch disposition and make decisions regarding quality assurance/control and compliance for all batches (investigations, retesting and re-inspections).  
  • Review and approve change controls related to product.
  • Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
  • Other duties will be assigned, as necessary.

Qualifications
  • 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, cell therapy, or Research & Development is preferred.
  • 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. 
  • Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.
  • Knowledge of cGMP regulations and FDA/EU guidance is required.
  • Manufacturing of cell based products as well as knowledge of Good Tissue Practices is required.
  • The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision. 
  • Comfortable with speaking and interacting with inspectors
  • 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 unplanned overtime (including nights and weekends) on little to no prior notice.
  • This position may require up to 10% domestic and international travel as business demands.

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.



Primary Location
United States-New Jersey-Raritan
Organization
Janssen Pharmaceuticals, Inc (6062)
Job Function
Quality Assurance
Requisition ID
8138180807