Analyst, Quality Control - CAR-T (Multiple Openings).

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Job description

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control - CAR-T (Multiple Openings)!

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 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 pharmaceutical products? Apply today for this exciting opportunity!

The 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
• Utilize electronic systems (LIMS, iLAB) for execution and documentation of testing
• Complete invalid assay and general laboratory investigation records, CAPAs, and change controls
• Train new laboratory personnel as needed
• Support Health Authority inspections
• Provide input to functional laboratory meetings
  
  

Education

Qualifications

• Minimum of a Bachelor's or equivalent degree in Biology, Biochemistry, Microbiology, Chemistry, or related scientific field is required; advanced degree (MSc., Ph.D.) preferred
  
  

Required

Skills & Experience:

• Minimum two (2) years of relevant work experience
• Demonstrated experience successfully working in an analytical role/level
• Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory
• Working knowledge of Quality systems
• Proficiency in basic and advanced analytical methodologies within a functional laboratory
• Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
• Proficiency with Microsoft Office Suite (Outlook, Excel, Word, and PowerPoint)
  
  

Preferred

• Experience working in Biopharmaceutical or Pharmaceutical industry in Cell and/or Gene Therapy
• Solid understanding and functional knowledge in the area of Flow Cytometry, qPCR, cell counts, and/or potency assays
• Proficient in performing technical writing (e.g., test methods, SOP's, protocols, etc.)
• Experience, training, or certification with Process Excellence tools and methodologies
• Experience with Quality Control document reviews and regulatory inspection processes
  
  

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
  
  

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-1000 US HIghway 202

Organization

Janssen Pharmaceuticals, Inc. (6062)

Job Function

Quality

Requisition ID

W