Quality Control Analyst, CART Critical Reagents
Publication date:
21 September 2024Workload:
100%Contract type:
Unlimited employment- Place of work:Raritan
Janssen Pharmaceuticals, a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Control Analyst, CAR-T Critical Reagents! (2nd Shift). This position will be located in Raritan, NJ
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.
Key Responsibilities:
- Conduct analytical testing to qualify critical reagents used in the CAR-T QC laboratories
- Perform analytical testing in compliance with all applicable procedures, GMP and GDP regulations
- Maintain a safe work environment in compliance with all applicable environmental, health, and safety regulations
- Perform peer review of laboratory data.
- Collaborate and coordinate with testing laboratories to obtain the data necessary to prepare documentation and issue Certificate of Analysis.
- Author and update SOPs, WIs and Protocols to support project using the Document Management System
- Maintain individual training completion in a compliant state
- Support laboratory related investigation records and CAPAs
- Assist in the execution of internal audits
- Provide input to functional laboratory meetings
- Provide input and take actions as a QC representative at cross-functional meetings