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Senior Analyst, CAR-T Manufacturing Batch Advocate

Description:

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Analyst, CAR-T Manufacturing Batch Advocate!

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!

The Batch Advocate Sr 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 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 exceptional release process flows
• Support development and future monitoring of new manufacturing facility workflows for batches that require delay

Qualifications:

Education:

• Minimum of a bachelor’s or equivalent University Degree required; focused degree in Immunology, Molecular Biology, Bio-Pharmaceutical Manufacturing, or equivalent field preferred

Experience and Skills:

Required:

• Minimum 4 years of relevant work experience
• GxP Technical Operations, Quality, or Manufacturing experience
• Demonstrated work experience in a CAR-T GMP manufacturing setting
• Extensive knowledge performing tests using and interpreting data from one or more of the following: Automated cell counters, Digital Drop PCR Methods, Multi-color flow cytometry, ELISA methods for cytokines, Cell Culture, and/or BAC-T sterility
• Experience in writing, implementing, and reviewing Operations manufacturing SOPs, Work Instructions, and Batch Records
• Strong interpersonal skills, positive mentality, and capability of working in a collaborative team environment to effectively relate to all aspects of the manufacturing teams

Other:

• Fluency in English and Dutch is required to proficiently read/write/speak to conduct technical discussions; fluency in German, Italian, French, Portuguese, and/or Spanish is preferred
• Requires availability within 12 hours to connect with sites as needed, locally and globally
• Requires up to 10% of domestic and/or international travel