Analyst Quality Control, Analytics

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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 an Analyst, Quality Control Analytics - This position will be located in Raritan, NJ! The role will operate under the following shift:
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

Experience and Skills:

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 with in 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 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…