Job ref: HMST031024 Job type: Permanent Location: Newry Closing date: Thursday 17 Oct 2024 17:00 Job Overview The Head of Manufacturing Sciences and Technology (MST) is responsible for leading all facets of Process Validation, Technology Transfer into manufacturing, GMP floor support and Continued Process Verification in accordance with current good manufacturing processes (cGMP), across a network of 5 sites. They will have a strong leadership capability and provide scientific mentorship to the MSAT team to ensure robust and reliable production processes are established through a meticulous technology transfer process to enable the site to meet and/or exceed commitments. This role will drive the planning, execution and customer interaction for the MSAT function during technology transfer from process development through to Commercial manufacturing. They will be accountable for all aspects of implementing, validating and monitoring robust and efficient manufacturing processes to produce commercial products. Main Activities/Tasks Responsible for maintaining a high performing team by hiring, training, motivating, and developing staff. Work cross functionally with process development, manufacturing, quality assurance, quality control, supply chain, and regulatory departments to effectively transfer and maintain processes. Leads the evaluation, remediation and optimization of products and processes using statistical tools to ensure safety, quality, delivery, and cost standards. Responsible for Process Validation and Continued Process Verification activities. Support manufacturing activities with active process monitoring and data trending, process deviation resolution, process improvements and scientific expertise including on-the -floor technical oversight. Ensure that changes to existing processes or the introduction of new processes are carried out and documented according to approved change control procedures and in compliance with cGMP requirements. Bridge the focus areas of R&D, Quality, EHS, Production, Supply Chain and Engineering to create common understanding and objectives and ensure robust products and flawless manufacturing. Provide business case for process improvement projects. Build and responsibly manage operational budgets for the MST organization. Essential Criteria: Minimum B.S. degree in Chemistry, biochemistry, chemical engineering, or related technical field OR a minimum of 5+ years relevant experience. 3+ years continuous leadership experience, managing managers. Strong interpersonal and presentation skills to discuss technical concepts internally and with clients. Strong technical knowledge and hands-on experience with pharmaceutical manufacturing and validation concepts and procedures in a cGMP environment. Demonstrated strong working knowledge of Tech Transfer (Internal and External) between Development and Manufacturing. Desirable Criteria: Master's degree or PhD. Ability to provide ideas, introduce new technology, and drive process improvements. Demonstrated understanding of multiple applicable techniques, including suspensions, solutions, aseptic manufacturing and tabletting. Additional Information: This role may be based in a site that produces and handles penicillin, and as such, this role would not be suitable for those that have a penicillin allergy. Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered. We regret that applications received after the closing date and time will not be accepted. To Apply Please forward your CV via the APPLY Now button below.