Johnson & Johnson Careers

QC Senior Analyst (Micro), CAR-T Manufacturing

Raritan, New Jersey
Quality Control


Job Description

Requisition ID: 1395190820

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for an QC Senior Analyst (Micro), CAR-T Manufacturing. 

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR T platform and investigational treatment.

The QC Senior Analyst (Micro), CAR-T Manufacturing will:

• Support method transfer and qualification related to endotoxin and sterility
• Create, review and approve relevant QC documents, SOP’s and WI’s.
• Write/ Review test methods, qualification protocols and reports
• Support laboratory investigations, root cause analysis and provide guidance for CAPAs
• Participate in training team members 
• Perform peer review/approval of laboratory data.
• Troubleshoot method, material and equipment related issues
• 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 Science or equivalent technical discipline is required. 
• A minimum of four (4) years within a biological and/or pharmaceutical industry is required.
• An advanced degree (MSc., Ph.D.) in a related field is preferred 
• Experience with microbiological techniques, such as bioburden, endotoxin, and sterility (traditional or Bac-T) is preferred
• Experience in a Quality Control setting is preferred
• 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 is required.
• Knowledge of Good Tissue Practices is required. 
• Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment is preferred
• Detailed knowledge of the shop floor manufacturing process is preferred 
• Comprehensive knowledge of trending using statistical analysis is preferred
• Ability to pay attention to details and follow the procedures is required
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision. 
• Excellent written and oral communication skill are required
• Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
• This position is located in Raritan, NJ and may require up to 10% of domestic travel. 

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


Primary Location
United States-New Jersey-Raritan-
Organization
Janssen Pharmaceuticals, Inc. (6062)
Job Function
Quality Control
Requisition ID
1395190820