Jim McKiernan<\b> is an engineer and CEO of McKiernan Associates. He has spent his career in manufacturing and supply chain, specializing in life sciences. He works at all levels of global organizations, able to engage with senior level executives in strategic discussions as well as working at shop floor level to get real change effected. His work has included many large-scale programs to implement operational excellence concepts such as lean and six sigma as well as working to ensure effective new product launch through effective cross-functional process between R&D and Technical Operations. Jim is also an active contributor to industry initiatives; he was a founder member of ISPE’s Operations Management Community of Practice and joint author of the recently published Good Practice Guide. He is an animated trainer running in-company education programs as well as successful courses at universities and business schools. Together with INSEAD he has developed and led an annual Masters’ module in Medical Product Supply at Copenhagen Business School. Jim’s career spans over 35 years ranging from hands-on functional management (Production Operations, Project Management) to consulting. He holds a Bachelor of Engineering (Honors), University College Dublin and a Lean Six Sigma Black Belt, American Society for Quality.