3! The number of internal CAR-T manufacturing sites at Novartis.
The Novartis Cell & Gene Therapy Clinical Manufacturing unit is seeking a Head, Strategy and Operational Excellence in East Hanover, NJ.
This role leads Operational Excellence for clinical manufacturing, engineering, qualification and quality control to ensure holistic and optimal processes.
Provide scientific and engineering expertise for process development and manufacturing activities. Be highly knowledgeable of trends and process-technology innovations. Be a resource to other departments for product and process knowledge, equipment, continuous improvement of processes and successful Technical and Analytical Transfers. This role will drive OpEx culture and awareness, build in OpEx capability at the site and ensure alignment with PMO and global OpEx initiatives across the CGT platform where possible.
* Responsible for optimizing process flow holistically and systematically to achieve capacity, turn-around time, and quality goals. * Using Lean Six Sigma techniques such as value stream mapping, Kaizens, Gemba walks to identify opportunities for improvement and to optimize current workflows and processes. * Coordinate with Quality Control and lean laboratory optimization testing workflow. * Questions the status quo and drives improvement of site procedures to enable faster throughput. * Participates in and facilitates root cause investigations on process and equipment deviations. * Act as process engineering representative in technology and/or product transfers. * Participate and provide input to the S&OP process to support the Site Planner with the scheduling.
* Work with process science and manufacturing support teams to identify next-generation improvements and technologies. * Lead cross-functional teams for automation integration efforts from development groups into GMP manufacturing. * Manage process related capital projects. * Provide appropriate and timely input to projects from concept through validation. * Generate project documentation i.e. concept studies, User Requirement Specification, Process Step Analysis, Utility Requirements, equipment layouts, Block Flow Diagrams, Process Flow Diagrams, P&ID's, process descriptions, equipment lists, utility requirements, equipment specifications and data sheets, schedules, cost estimates, commissioning documents including FAT and SAT, Process Change Requests and Critical Change Requests. * Lead and/or execute FAT, Commissioning and SAT jointly with project team.