Johnson & Johnson Careers
QC Senior Analyst, CAR-T Manufacturing
Raritan, New Jersey
Requisition ID: 9765190820
Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a QC Senior 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 Senior Analyst conducts biochemical, microbiological, and/or general testing of final product samples submitted to the QC laboratories. The position requires testing to be completed in compliance with all applicable procedures, standards and GMP regulations. Previous work experience in Cell and Gene Therapy preferred. Prior working knowledge in the area of Flow Cytometry, qPCR, cell counts and potency assays preferred. The QC Senior Analyst typically works with a team of 5 – 15 other Analysts within a functional laboratory of the Quality Control department.
Additional Responsibilities Include:
• Perform analytical testing in compliance with all applicable procedures and GMP regulations
• Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
• Perform peer review of laboratory data and logbooks.
• Utilize electronic systems (LIMS, iLAB) for execution and documentation of testing
• Train new laboratory personnel
• Complete invalid assay and general laboratory investigation records, CAPAs, change controls
• Support Health Authority inspections
• Provide input to functional laboratory meetings
Knowledge, skill, ability and experience required:
• Skilled in all basic and advanced analytical methodologies within the functional laboratory
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems
• Knowledge and awareness of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC
• Proficient in performing technical writing
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)
• A Bachelors degree with a minimum of four (4) years related experience in medical device, biopharmaceutical or pharmaceutical industry or a Master Degree with a minimum two (2) years of experience in a related field or an advanced degree (Ph.D.) in a related field is required.
• A degree in Biology, Biochemistry, Microbiology Chemistry or related field is preferred.
• Experience in a Quality Control setting is preferred
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.
• Experience with electronic systems such as (LIMS iLAB) is preferred.
• Working knowledge in the area of Flow Cytometry, qPCR, cell counts and potency assays 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
• This position will occasionally require to lift up to 20 pounds.
• 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 5% 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)