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 manufacturing 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.

Process Chemists (Supervisors) take end to end ownership of 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 Chemists (Supervisors) play a key part in clinical process development and subsequent commercial launch.

The Process Chemist (Supervisor) is a key member of a dynamic, highly competent, engaged team of colleagues responsible for delivering on our Portfolio clinical supply demands with excellent performance across the fundamentals of safety, quality and supply.

The Process Chemist (Supervisor) team are committed to continuous improvement, technical up-skilling and personal development in a performance-driven environment.Process Chemists (Supervisors) may be required to travel periodically to observe new processes in transferring facilities; and attend, contribute to and present at on and off-site meetings as required.

The key accountabilities of the Process Chemist (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 systems and controls to generate and execute processing steps.
• Troubleshooting process upsets.
• Clinical process development.
• Participation in co-development, launch and technical transfer of processes from the RCMF to the commercial manufacturing organisation (PGS).
• Partnering with CRD lads, Analytical R&D, Quality Operations, Logistics, Global Materials Management, Engineering, and other partner functional lines.
• Development of procedures, training materials, 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.
• Collection of data, trending, and generation of technical reports.
• Leading post-campaign reviews with Pharm Sci colleagues.
• Lead and/or support process investigations and resolution of issues that may occur on plant.
• Maintain readiness for and participate in routine safety inspections, regulatory inspections, and audits.
• Additional areas of responsibility as the business requires.

Qualifications & Experience

• It is expected that the successful candidate be qualified to at least B.Sc. level in chemistry or related discipline.
• At least 5 years relevant experience in commercial or clinical API small molecule manufacturing, and new product start-up / tech transfer.

Core Competencies

• 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 improvement-oriented work environment.
• Excellent interpersonal skills, team orientation and attention to detail.
• Open and team-based communication skills 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.
• Continuous manufacturing experience is not necessary but beneficial.