Senior Analyst Quality Control CAR T

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 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. Are you interested in joining a team that is positively impacting patients'' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity! The Senior QC Analyst is responsible for conducting biochemical, microbiological, and/or general testing of final product samples submitted to the QC laboratories. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 15 other Analysts within the functional laboratory of the Quality Control department. Key Responsibilities: Perform analytical testing and maintain a safe work environment in compliance with all applicable procedures, EHS, and GMP regulations Perform peer review of laboratory data and logbooks Use 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 QualificationsEducation: Minimum of a Bachelors or equivalent University Degree required; advanced degree (MSc., Ph.D.) or focused degree in Biology, Biochemistry, Microbiology, Chemistry, or related scientific field is preferred Skills & Experience: Required: Minimum four (4) years of relevant work experience Experience working in Biopharmaceutical or Pharmaceutical industry Experience with aseptic processing in biosafety cabinets and/or ISO 5 clean room Demonstrated experience successfully working in an analyst role/level and proficiency using analytical methodologies within a functional laboratory Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory Working knowledge of Quality systems Proficient in performing technical writing (e.g., test methods, SOP''s, protocols, etc.) Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards Experience with Quality Control document reviews and regulatory inspection processes Excellent written and verbal communication skills Preferred: Work experience in Cell and/or Gene Therapy Solid understanding and functional knowledge in the areas of Flow Cytometry, qPCR, cell counts, and/or potency assays Experience, training, or certification with Process Excellence tools and methodologies Knowledge of Good Tissue Practices Other: Requires ability and flexibility to work 10-hour shifts between the operational hours of 8am - 6pm (Wednesday - Saturday or Sunday - Wednesday), and provide occasional support on the weekends or other shifts Requires the ability to meet the physical demands (lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting), to perform visual inspections of materials (color, appearance, particles, etc.), and to document observations during laboratory testing Requires up to 5% domestic travel to other sites/locations At Johnson & Johnson, were on a mission to change the trajectory of health for humanity. That starts by creating the worlds healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.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. For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit . Primary LocationUnited States-New Jersey-Raritan-1000 US HIghway 202OrganizationJanssen Pharmaceuticals, Inc. (6062)Job FunctionQualityRequisition ID2206050383W

Created: 2025-09-06