RCMF Process Supervisor

RCMF Process Supervisor Role Summary The Ringaskiddy Clinical Manufacturing Facility (RCMF) is a new building on the Ringaskiddy API site. It is a multi-product clinical API manufacturing facility enabled for both traditional batch synthesis and continuous manufacturing via our new modular FAST platforms. The facility design is focused on combining existing capabilities from our clinical workflows with the very best advances in technology and architecture to build a truly contemporary API clinical facility, which will support the needs of our new products small molecule portfolio into the future. The RCMF is part of Chemical Research & Development (CRD) and will scale up new clinical products developed in our CRD laboratories at our research sites and will tech transfer successful candidates from the RCMF to our commercial manufacturing plants. The Process Supervisor is a key member of a dynamic, highly competent, engaged team of colleagues responsible for delivering on our Production Schedule with excellent performance across the fundamentals of safety, quality, supply, and cost. The Process Supervisors take end to end ownership of our clinical API manufacturing programs. They interface with the R&D project teams and oversee all aspects of the technical transfer, from early engagement, right through start-up, manufacturing, and delivery. The Process Supervisors play a key part in clinical process development and subsequent commercial launch. The Process Supervisor team are committed to continuous improvement, technical upskilling and personal development in a performance-driven environment. Production Supervisors may be required to travel periodically to observe new processes in transferring facilities; attend, contribute to and present at on and off-site meetings as required. The accountabilities of the Process Supervisor position include: Technical transfer of processes from R&D laboratories and the Kilo Lab into the RCMF manufacturing facility (batch & continuous). Generation of optimal process fits/equipment configurations to meet process needs. Understanding and use of manufacturing control systems to generate and execute processing steps. Troubleshooting plant batch and continuous manufacturing operations. Clinical process development. Participation in co-development, launch and technical transfer of processes from the RCMF to the commercial manufacturing organisation (PGS). Partner with Quality Operation, Analytical R&D, Logistics, Global Materials Management, Engineering, and other partner functional lines. Development of procedures, training, manufacturing, and cleaning records and other documentation as required to facilitate cGMP manufacturing. Participate in Continuous Improvement (CI) initiatives. Deliver efficiencies and speed to market for new product introductions. Flawless RCMF manufacturing execution against safety, quality and customer service metrics for clinical campaigns conducted within the facility. Monitoring and optimizing the quality and yield of the products including optimization of the process with regard to efficiency, quality and safety. Real-time analysis of data (e.g. Process Analytical Technology data) and real-time decision-making in partnership with Pharm Sci colleagues. Collection of data, trending, and generation of technical reports. Leading post-campaign reviews with Pharm Sci colleagues. Participating in cross-functional teams leading to accomplishment of RCMF goals. Partner with analytical colleagues to ensure effective integrated process analytics and control. Provide support for digital initiatives and new technologies. Lead and supporting investigations and resolution of issues that may occur on plant. Completion of personal training in compliance with procedures as part of a comprehensive learning and development program. Providing training and support to new staff members of the RCMF team to ensure that learning objectives are met. Maintain readiness for and participate in routine safety inspections, regulatory inspections, and audits. Coordination of process equipment mechanical and electrical preps for processing. Additional areas of responsibility as the business requires. Qualifications/Skills, Knowledge, Experience & Competencies: ItisexpectedthatthesuccessfulcandidatebequalifiedtoatleastB.Sc.levelin chemistry or engineering with at least 3-5 years relevant experience in commercial or clinical API small molecule manufacturing, and new product start-up / tech transfer. Continuous manufacturing experience is not necessary but would be advantageous. Excellent technical, problem-solving and communication skills. Focus on flawless execution and flexibility to get the job done. Comfortable as part of a highly competent and self-motivated team, and with an ability to deal with the challenges that a new start-up and cutting-edge facility may present. Demonstrated evidence of high performance in a continuous improvementoriented work environment. Excellent interpersonal skills, team orientation and attention to detail. Facilitation of an environment of open and team-based communication where all members of the team work together to ensure that business targets are met. Strong ability to lead, challenge and positively influence in an interactive team environment. Demonstrated ability to work on own initiative and proactively respond to business needs. Skills: API Small Molecule Process Development RCMF GMP