Johnson & Johnson Careers

Operations Technical Specialist, CAR-T

Raritan, New Jersey
Technology Operations


Job Description

Requisition ID: 9005180808

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Operation Technical Specialist, CAR-T to 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.  

 

Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns in several therapeutic areas, including Cardiovascular, Metabolic, Mental Health, and Pain Management. Please visit www.JanssenPharmaceuticalsInc.com for more information. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

 

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

 

As the Technical Specialist, Operations Technical Support, CAR-T, you will:

  • Support the start-up and operation of the Advanced Therapy Manufacturing facility.  
  • Work within the Operations department to support the development and routine operations of a new CAR-T manufacturing process.  
  • You will be support resolution of process related issues and will partner closely with Quality, Compliance and Technical Subject Matter Experts (SMEs) to drive accelerated resolution and escalation as appropriate.  
  • Support complex manufacturing investigations quickly driving to root cause to meet critical release windows.
  • Support process changes arising from updates to materials, excipients or finished goods requirements. 
  • Support complaint investigations and resolutions.
  • Drive process optimizations to enable seamless transition from clinical to commercial operations.
  • Act as technical SME for interaction outside the site including: External Partners, Regulatory Agencies, and Vendors. 


Qualifications

  • A minimum of a Bachelor’s degree is required, preferably with a focus in Engineering, Biology, or Chemistry. Master’s or higher degree is preferred.  
  • A minimum of six (6) years of related experience in a regulated environment is required; pharmaceuticals preferred.
  • Prior experience with CAR-T and/or cell therapy processing is highly desired.
  • Strong working knowledge of current Good Manufacturing Practices (cGMP’s) and experience leading complex investigations or process development are required.
  • Demonstrated technical leadership within pharmaceutical or similar environment is highly desired.
  • Hands-on experience with single-use technologies, closed systems, and cold chain/cryogenic technologies is preferred. 
  • Experience with the start-up of new biopharmaceutical manufacturing facilities is preferred.
  • Experience with MS Project, Minitab and other business-related systems is preferred.  
  • This position will be based in Raritan, NJ and may require up to twenty percent (20%) of domestic and international travel. 


Primary Location
United States-New Jersey-Raritan
Organization
Janssen Pharmaceuticals, Inc (6062)
Job Function
Technology Operations
Requisition ID
9005180808