Analyst, Quality Control Analytics (2 openings)

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Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for two Analyst, Quality Control Analytics - This position will be located in Raritan, NJ, with a work shift of Wednesday- Saturday 2pm-12am.

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.
• Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.
• Work with Process Development team, Quality, and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.
• Perform peer review/approval of laboratory data.
• Use electronic systems (LIMS, iLAB) for execution and documentation of testing.
• Build, review, and approve relevant QC documents, SOPs, and WIs.

Education:

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

Required:

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

Preferred:

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

Other:

• Requires ability and flexibility to work 10-hour shifts Second Shift (2PM-12AM) Weds-Sat.
• 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
• The anticipated base pay range for this position is $61,000 to $110,000 USD.

Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.

#CAR-T

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For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits