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SUMMARY

The Technical Lead, Advanced Therapies Supply Chain MS&T supports the Raritan MS&T team as a technical individual contributor by providing specialist knowledge and expertise of cell and gene therapy processes and/or process technologies. This individual will own the process knowledge of the cell and gene therapy manufacturing process technology and maintain oversight on process capability to ensure processes are robust and continuously improving. They will also oversee the processes and standards to maintain and improve existing and to implement new innovative manufacturing technologies.

• Provide support and technical expertise to the Manufacturing team in support of ongoing technical transfer and manufacturing operations.
• Support writing of SOPs for Manufacturing and Quality Risk Assessments for existing and new/changed processes.
• Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously
• Integrate cross-functional issues and balance competing priorities effectively. Must be able to manage shifting priorities to meet critical deadlines in a fast paced and dynamic, growing environment.
• Support Manufacturing team to troubleshoot and resolve complex scientific/technical problems.
• Ensure MES (manufacturing execution system) matches technical process; equations / instructions / workflows are correct and engineering controls are appropriate and optimal.
• Provide technical expertise to drive the implementation of process improvements that would provide reduction in COGs, increase throughput, capacity and quality compliance.
• Provide technical expertise in automation projects from user requirements, design evaluation, specification review through to testing and implementation in a GMP manufacturing environment.
• Work cross-functionally across MS&T and interface with external vendors to drive the design and implementation of automation platforms for cell therapy development and manufacturing.
• Perform technical feasibility studies related to process improvement and implementation of new manufacturing technologies.
• Provide SME expertise to perform process characterization of cell therapy automation technologies, including process development, FATs, SATs, and IQ/OQ/PQ testing.
• Ensure successful manufacturing process comparability and process validation runs by assessing risk, establishing preventative measures, investigating, and troubleshooting equipment and process issues prior to implementation into manufacturing.
• This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.