CAR-T Manufacturing Batch Advocate, Senior Analyst - Raritan New Jersey

Company: Disability Solutions
Location: Raritan, New Jersey
Posted On: 04/21/2024

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a CAR-T Manufacturing Batch Advocate, Senior Analyst! At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at 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! The CAR-T Manufacturing Batch Advocate, Senior Analyst is responsible for directly providing hope for our CAR-T patients. As a team, we work directly with relevant patient batch partners at the manufacturing facility applying helpful specialized technical influence at any step within the manufacture or release process. The Lead serves as the 'Voice of the Batch.' The Batch Advocate team, Medical Affairs, and a specialized CAR-T site-facing team will speak with commercial sites providing technical insight to facilitate informed patient treatment decisions. The team directly influences and improves release time of all batches. Key Responsibilities:

• Collaborate with CAR-T manufacturing and Quality teams to identify early indications a batch may be delayed for any reason
• Immediately assess and prioritize any issue for further alert, action or monitoring
• Upon confirmation of a batch delay, populate a specialized batch monitoring platform
• Responsibilities span receipt to release from the CAR-T manufacturing facility
• Provide a specialized level of care to every delayed batch of CAR-T material
• Collaborate with manufacturing team members to monitor and add influence to expedite resolution of any realized batch delays
• Maintain a digital case report for each patient batch requiring delay or release monitoring
• Support onboarding and training of new country commercial launches for outstanding release process flows
• Support development and future monitoring of new manufacturing facility workflows for batches that require delay More...

      

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