Supervisor, QC Critical Reagent - CAR-T (2nd Shift)

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Supervisor, Quality Control (QC) Critical Reagent - CAR-T (2nd Shift)!

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 2nd shift QC Supervisor is responsible for overseeing day-to-day Quality Control activities for a designated functional laboratory, ensuring GMP compliance, accuracy, and timeliness of specified testing processes. They carry out duties in compliance with all local, state, and federal regulations and guidelines (including FDA, EPA, and OSHA) as well as all company and site policies and procedures. They are responsible for carrying out supervisory responsibilities in accordance with the organization’s policies and applicable laws; responsibilities include interviewing, hiring, performance review, addressing complaints, resolving conflict, and supporting internal and external audits. They will typically guide daily work activities of 10-12 direct staff within a functional laboratory of the Quality Control department.

Key Responsibilities:

• Manage analyst schedule to support Critical Reagent Qualifications
• Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards
• Review/approve documents as a QC department subject matter expert (SME)
• Oversee timely completion of laboratory investigation of OOS/ invalid assays, CAPAs, and change controls
• Ensure accuracy and completeness of executed analytical method transfer activities
• Set testing priorities and manage work assignments
• Maintain individual training completion in a compliant state
• Mentor, train, and supervise quality control staff, as well as evaluate performance and provide opportunities for growth
• Communicate department objectives and metrics
• Support internal and Health Authority audits and related investigations