Manufacturing Supervisor, CAR-T (2nd Shift )

Janssen Pharmaceuticals, Inc., a Johnson & Johnson's Family of Companies member, is recruiting for a Manufacturing Supervisor, CAR-T - 2nd Shift!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we work 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 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.

• Lead and supervise multiple units within the CART process operations (i.e., component preparation manufacturing, MFG support operations, Mock cell, Cryopreservation, CART process, and Lenti manufacturing) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to cGMP requirements.
• Own the daily start of shift operations meetings and the daily wrap-up production meetings and assign individuals their daily production tasks to complete and ensure compliance and successful completion of work-related tasks.
• 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, create/revise operational procedures, including manufacturing work instructions, master batch records, and forms, and support and handle change controls.
• Work with the Operations Manager to help oversee the development of production personnel and provide input on personnel performance.
• 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.

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

• Minimum 4 years of relevant work experience
• Experience in Manufacturing, Quality, or Engineering
• Excellent communication and interpersonal skills
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, and Outlook)

• Operations experience within a cGMP environment in the biotech/biopharma industry
• Experience in an aseptic manufacturing environment
• Experience leading teams
• Experience working in cGMP systems, including PASx, eLIMs, Siemens, and SAP
• Operational Excellence and Lean Manufacturing experience, training, or certification

• Ability to work 2:00 pm-10:30 pm on a Tuesday- Saturday schedule, required.
• Ability to lift to 25 lbs. and to stand for extended periods, required.
• May require up to 10% domestic travel to other sites/locations.