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Job Function:
Quality
Job Sub Function:
Quality Control
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America
Job Description:
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.
Qualifications:
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…