PROCESS SUPERVISOR - ROLE SUMMARY

The RCMF facility is a multi-product clinical API manufacturing facility enabled for continuous processing using our FAST platforms.  The 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 will scale up new clinical products developed in our CRD laboratories at our research sites in the U.S. (Groton, Connecticut) and will tech transfer successful new products from the RCMF to our commercial manufacturing site in Ringaskiddy.

The Process Supervisor works in Process Teams that are aligned with new product introduction workflows utilising cutting edge continuous manufacturing technologies. Process Supervisors are members of a dynamic, highly competent, engaged team of colleagues responsible for delivering a fully operational facility with excellent performance across the fundamentals of safety, quality, supply and cost. Process Supervisors will develop manufacturing techniques consistent with the requirements of Pfizer’s newest products, and will be committed to continuous improvement, technical up-skilling and personal development in a performance-driven environment.  Process Supervisors will 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:

• Observation of processes & technologies in Pharm Sci Kilo lab facility
• Co-lead technical transfer of processes from CRD laboratories to CRD Manufacturing
• Generation of optimal process fits/equipment configurations to meet process needs
• Preparation of RCMF for new product activity from a safety, quality and operational perspective through adherence to the start-up Standard Work Plan
• Understanding and use of manufacturing control systems to execute processing steps
• 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

• Leading and supporting investigation and resolution of process problems that may occur on plant
• 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.
• Writing, review and revision of manufacturing documentation as necessary e.g. standard operating procedures, batch books etc.
• Completion of personal training requirements in compliance with site procedures
• Providing training and support to new staff members of the RCMF team to ensure that learning objectives are met.
• Co-lead technical transfer of processes from RCMF to Ringaskiddy commercial production facilities
• Readiness for and participation in routine safety and quality inspections
• Continuous improvement of the workflows associated with the RCMF operation

BASIC QUALIFICATIONS

• It is expected that the successful candidate be qualified to B.Sc. level in an appropriate discipline (engineering or chemistry) with relevant experience in pharmaceutical manufacturing.

Qualifications/Skills, Knowledge & Experience:

• Relevant experience in an API manufacturing or API technical (process chemistry, process engineering) environment
• It is also desirable that the successful candidate has new product introduction experience at clinical or commercial scale manufacturing.
• API continuous manufacturing experience while not essential would be advantageous
• Excellent technical, problem-solving and communication skills
• Performance at a consistent level of excellence in a dynamic operating environment, where the focus will be on flawless execution and demonstrated flexibility to get the job done
• Comfortable as part of a highly competent and self-motivated team, and will have the ability to deal with the challenges that a facility start-up 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 Process 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

 
Work Location Assignment: On Premise

Manufacturing