Manufacturing Lead CAR T - 1st shift bi

Supply Chain Manufacturing

Manufacturing Pharmaceutical Process Operations

Business Enablement/Support

Raritan, New Jersey, United States of America

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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 the manufacturing of our pharmaceutical products?

The Manufacturing Lead CAR-T is responsible for supporting in a leadership capacity in the daily production of a personalized cell therapy to support both Clinical and commercial requirements in a sterile cGMP environment. Their job duties will be performed within a team-based environment, on an assigned production shift schedule.

• Lead a specific Processing Manufacturing Unit within the CART process operations (Day 0, Cell Culture, Day 10 or Component Prep)
• Lead daily shift operations meetings (Tier Meeting) where you would assign individuals their daily production task to complete and ensure compliance and successful completion of work-related tasks (Supervisor Delegation)
• Work closely with operations personnel on the production floor to provide clear guidance and perform production tasks as needed to help the team, in a manner consistent with safety policies, quality systems, and cGMP requirements.
• Support manufacturing investigations, operational procedures changes as an SME on the assigned process area, including manufacturing work instructions, master batch records, forms, and support and support change controls.
• Build positive relationships with Manufacturing, Engineering, and Quality to ensure seamless execution of daily production tasks and work as part of a cross-functional team to address production issues as the first point of contact for operators on the production floor.
• Support the development of manufacturing processes and work with cross-functional teams to drive continuous improvements and efficiencies within cell therapy Operations.
• Participate in various department projects and handle challenging priorities in a fast paced and dynamic environment
• Participate in production runs in critical situations when needed. Manufacturing Leads should be qualified in the process they provide oversight to, to better understand Team challenges If a Manufacturing Lead for an Aseptic Process the Lead should maintain their APQ Qualifications and process in the event of staff shortages.
• In the event production runs past shift end time the Manufacturing Lead will be required to stay with their processing unit until Batches are completed

• Minimum of an Associate's, Vocational, Technical/Trade, or equivalent degree/certificate is required;
  Bachelor's degree or focused degree in Science, Engineering, or related field preferred