Senior Manager Quality Control, CAR-T in Raritan, New Jersey | DiversityInc Careers
 

Senior Manager Quality Control, CAR-T


Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager Quality Control, CAR-T. 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 Senior Manager Quality Control, CAR-T Manufacturing manages all aspects of Quality Control (QC), in support of the Raritan Janssen Supply Chain (JSC) site, in full compliance with established cGMP and JSC requirements. 


In this role, you will develop and implement long-term strategies, and execution of Quality Control programs and manages a team of people leaders and technical professionals within the QC department based on assigned work, direction, coaching and developing capabilities.


Responsibilities include but are not limited to:
  • Ensuring adequate training (skills-based, cGMP and safety) of management and associates within the department.
  • Raw material, in-process, environmental/utility, product release, and stability testing.
  • Investigation of laboratory non-conformances (events, deviations, and invalid assays).
  • Maintenance, calibration and qualification of laboratory instruments and equipment.
  • Test method verification, qualification, validation and/or transfer activities in the QC laboratories.
  • Process Performance Qualification and Continued Process Verification activities associated with QC laboratory testing.
  • Provides expertise in troubleshooting complex laboratory issues and demonstrates strong reasoning skills in support of ongoing laboratory investigations.
  • Maintains detailed knowledge of industry guidelines/trends, regulatory requirements, and applicable pharmacopeia while remaining current in on-the-job training requirements.
  • Collaborates with Quality Assurance, Manufacturing, Technical Operations, Engineering and Maintenance to support business needs.
  • Contributes to global strategies related to QC laboratories which align with compliance and business objects as well as the overall J&J vision.
  • Manages departmental budget and resources; prepares staffing plans. Adjusts roles and responsibilities of department to meet business needs.
  • 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 related to manufacturing is required.
  • Experience in clinical quality, method development, cell banking, or Research & Development is preferred.
  • Experience with cell therapy is preferred.
  • Proven cycles of success with people management and leadership experience is required.
  • Experience working with Quality systems is required.
  • Experience with quality support in clinical manufacture or NPI is preferred. 
  • Extensive knowledge of chemical, biochemical and microbiological concepts is required.
  • Ability to apply basic and advanced mathematical concepts (including statistics) in the evaluation of laboratory data is required.
  • Knowledge of cGMP regulations and FDA/EU guidance 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 or 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 Control
Requisition ID
1594180910