CAR-T Process Analytics Associate

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Process Analytics Associate.

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!

This role functions to support and ensure data integrity for the electronic data management systems encompassing a broad range of data streams associated with CAR-T development and manufacturing. The preferred candidate will have demonstrated experience in GMP manufacturing and data management with appropriate statistical analysis capabilities.

Key Responsibilities:

• Work with paper and electronic systems MES, SAP, LIMS, Anaplan, eLN, etc. to aggregate and verify data for manufacturing performance tracking and trending. Responsible for development of routine reports with verified data used in reporting and analysis
• Participate in the design and maintenance of tools, workflows, systems, and policy to maintain data quality for the integration of data from multiple sources
• Support investigations to provide manufacturing data for deviation investigation and support with data analysis and visualization as required.
• Provide support for Technical Operations group with data support including data analysis assistance and data integrity review of trend investigations, process improvement study reports, regulatory responses, and Continuing Process Validation
• Support Manufacturing Dashboard activities including updating, maintaining and creation of new visualizations
• Conduct impact assessments for process and batch record change controls to assess data collection strategy and physical or coding impact on data management and visualization tools