Analyst, Quality Control Analytics - Car-T

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control Analytics - 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 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.

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 to be part of the #CAR-T team!

The Quality Control Analyst is responsible for completing QC testing related to the manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

Key Responsibilities:

• Ensure testing is completed in compliance with all applicable procedures, standards, and current Good Manufacturing Practices regulations.
• Perform peer review/approval of laboratory data.
• Work with Process Development team, Quality, and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
• Use electronic systems (LIMS, iLAB) for execution and documentation of testing.
• Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
• Build, review, and approve relevant QC documents, SOP’s, and WI’s.

Qualifications

Education:

• Minimum of a Bachelor’s or equivalent University Degree required; focused degree in Biology, Biochemistry, Microbiology, or related scientific field is preferred

Experience and Skills:

Required:

• Excellent written and verbal communication skills
• Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
• Minimum 2 years of relevant work experience

Preferred:

• Experience in a Quality Control setting
• Experience with LIMs and SAP or equivalent systems
• Experience within Biopharmaceutical or Pharmaceutical industry
• Work experience in Cell and/or Gene Therapy or Biologics

Other:

• 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
• 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

The anticipated base pay range for this position is $60,000 to $96,600.

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 www.careers.jnj.com .