Microbiology Analyst, Quality Control - CAR-T Manufacturing (Multiple Openings / Shifts)

Janssen Pharmaceutical, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for Microbiology Analysts, Quality Control - CAR-T Manufacturing (Multiple Openings / Shifts)!

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 Microbiology CAR-T Manufacturing QC Analyst is responsible for collaborating with the Operations Team to conduct environmental monitoring within the manufacturing facility. Additional responsibilities in the QC laboratory include environmental monitoring plate reads and endotoxin testing. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and cGMP regulations. They typically work with a team of 5 – 15 other Associates within the functional Quality Control laboratory and the Manufacturing area.

Key Responsibilities:

• Participate in CAR-T manufacturing facility commissioning and qualification.
• Perform compressed gas sampling and Routine Environmental Monitoring of classified areas within the Raritan CAR-T manufacturing facility.
• Perform endotoxin testing.
• Participate in gown qualification and requalification of personnel.
• Create, review, and approve relevant QC documents, SOPs, and WIs.
• Support Aseptic Process Simulations and visual inspection of components.
• Utilize electronic systems (eLIMS) for execution and documentation of testing.
• Perform peer data review/approval of laboratory data.
• Initiate quality investigations related to environmental monitoring.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.