Johnson & Johnson Careers
QC Analyst, CAR-T Manufacturing (1 of 2)
Raritan, New Jersey
Requisition ID: 8021190221
Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a QC Analyst, 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 Analyst, CAR-T Manufacturing will:
• Be responsible for the completion of QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
• Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.
• Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
• Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
• Perform peer review/approval of laboratory data.
• Utilize electronic systems (LIMS, MES) for execution and documentation of testing.
• Create, review and approve relevant QC documents, SOP’s and WI’s.
• 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 two (2) years within a biological and/or pharmaceutical industry is required.
• Relevant micro experience related to manufacturing is required.
• 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.
• Experience with electronic systems such as (LIMS, MES) is preferred.
• Detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment is preferred.
• Excellent written and oral communication skill are required
• Candidates must be able to accommodate shift schedule. Shifts may include weekend and evening work as required by the manufacturing process.
• 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.
United States-New Jersey-Raritan-
Janssen Pharmaceuticals, Inc (6062)