NPI Launch Site lead

IrishJobs

Mayo, Leitrim, Ireland

Mayo, Leitrim, Ireland

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About

Team Horizon is seeking a NPI Launch Site lead for our client based in Mayo. The NPI Launch Site lead will report to the Director of the Tech Center business unit and be responsible for the Site New Product Introduction Programs. This position has responsibility for providing direct oversight, management, and leadership with minimal technical or administrative guidance, as well as responsibility for all aspects of technical process support such as but not limited to project management, process monitoring and validation programs within the site. This includes leadership of in-line product support for processes, project definition and demonstration, and process improvements/productivity while assuring compliance with regulatory agencies. These activities involve economic feasibility studies toward objectives assigned or approved by site leadership. Why you should apply: This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses. There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve peoples lives. Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand internationally. What you will be doing: Lead personnel (team of 7-9) responsible for New Product Introduction Programs of the site for Biologics. Drive Drug Product Technology transfers to manufacturing, including the financial aspects of each project. Provide technical guidance and continuous improvement support for commercial and new product introductions on day-to-day production and processing issues: problem solving, deviations, manufacturing documentation changes, etc. Source for plant consistency across the Division, share problem-solving activities, and maintain updated technical product history. Provide technical assistance with the implementation of changes in manufacturing equipment, batch size, ingredient supplier and experimental batches as needed. Ensure that products and processes are kept in compliance with validation requirements. Identify and solve technical problems independently for new products and for commercial operations. Plan data collection organizes results and applies statistical methodology. Presents numerical information through computer readouts, graphs, charts and tables, written reports and/or other methods. Evaluate new process equipment and advises management about areas of opportunity in the application of novel technologies Implement at plant level global technical initiatives as: new technologies, suppliers, methods, etc. and provide tactical perspectives Assure fulfilments of environmental, health, and safety (EH&S) requirements and compliance obligations, promote continuous improvement, and consider EH&S aspects during the design and change process. What you need to apply: M.Sc. in a relevant Science area and extensive experience in a hands on Process Engineering or development for new product introduction position. Experience of managing and leading professional teams that include Engineers and or Scientist personnel. Experience leading product transfer and New Product Introduction projects. Regulatory filing experience as well as familiarity with HA audits. Excellent communication and interpersonal skills for interaction with both internal departments and other sites worldwide (QA, Validation, IS, EHS, R&D, S&T). Computer literate with knowledge of statistical methods, data assimilation and interpretation. Capable to positively influence department employees and/or contributors from other disciplines or peers of higher managerial levels to obtain decision approvals for critical courses of action, either exception or planned. Skills: Biologics NPI Leadership

TLNT1_IJ

Mayo, Leitrim, Ireland

Languages

English

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