Job Description
**Clinical API Manufacturing Process Supervisor**
**Summary:** We are seeking a highly skilled Process Supervisor to oversee clinical API manufacturing programs, ensuring flawless execution and quality delivery.
The Ringaskiddy Clinical Manufacturing Facility (RCMF) is a state-of-the-art facility that combines traditional batch synthesis and continuous manufacturing via modular FAST platforms. As a key member of a dynamic team, the Process Supervisor will take end-to-end ownership of clinical API manufacturing programs, interfacing with R&D project teams and overseeing technical transfer, start-up, manufacturing, and delivery.
The Process Supervisor will play a key part in clinical process development and commercial launch, driving continuous improvement, technical up-skilling, and personal development in a performance-driven environment. They will troubleshoot plant batch and continuous manufacturing operations, generate optimal process fits/equipment configurations, and understand and use manufacturing control systems.
**Key Responsibilities:**
- 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
- 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
**Qualifications/Skills, Knowledge, Experience & Competencies:**
- Qualified to at least B.Sc. level in 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 improvement-oriented 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