The following pharmaceutical industry professionals have been elected to positions on the 2009-2010 ISPE International Board of Directors:
Alan Mac Neice, Chairman - Mr. Mac Neice was most recently the Project Director for Biologics at Elan's Biopharmaceutical Science's campus in Ireland. His 23-year career has been entirely within the manufacturing sector of the pharmaceutical industry and he has worked with five different US and European multi-nationals in a diverse range of manufacturing operations, including chemical APIs, biotech APIs, aseptic dose forms, oral solid dose forms, and the extraction of natural medicines. A member of the Ireland Affiliate since 1992, and a member of the Board since 2005, Mr. Mac Neice has been a committed ISPE organizer, speaker, and advisor.
Andre Walker, Vice Chairman - Mr. Walker is the Director of Manufacturing Engineering for Biogen Idec's Commercial and Clinical Operations in Cambridge, Massachusetts, USA, with responsibility for all GMP equipment, utilities, metrology, and validation. He has more than 25 years of experience in the areas of process development, scale-up, implementation, validation, and manufacturing support. A member of the ISPE International Board of Directors since 2003, he also serves on the Resource Analysis Task Team, the Membership Services Committee, and the Biotech Community of Practice Steering Committee.
Dr. Arthur (Randy) Perez, Treasurer - Dr. Perez is the Executive Expert of IT Quality Assurance for Novartis Pharmaceuticals and has served on the ISPE International Board of Directors since 2005. His responsibilities at Novartis include a wide range of IT compliance issues and he currently serves on several global Novartis teams dealing with computer systems compliance issues. During his 24-year tenure at Novartis, he has developed a broad range of experience, working as a chemistry group leader in process research, managing a chemical manufacturing process validation program, and running a QA validation group for pharmaceutical operations. Dr. Perez has been a speaker and a course leader at numerous ISPE continuing education seminars in the US and Europe, and has been published in industry journals and textbooks.
Dr. Charlotte Enghave Fruergaard, Secretary - Dr. Enghave Fruergaard is a senior consultant in the Finished Product Department at NNE Pharmaplan in Denmark. She has 13 years of experience with pharmaceutical projects and broad experience within the pharmaceutical manufacturing of sterile bulk. She is also a leading expert within isolator and barrier technology and associated sterilization techniques. She holds an MSc in mechanical engineering and a PhD in measuring technique. Dr. Enghave Fruergaard has been a Member of ISPE for 13 years, co-founder of ISPE Nordic Affiliate, a steering committee member of ISPE's Sterile Products Processing Community of Practice, and a member of ISPE's Technology-Based Learning Committee.
Damian Greene, Director - Mr. Greene works for Pfizer Global Manufacturing in New York, USA, beginning his career with that company in 1983 as a production supervisor at the Indiana, USA site. He has worked in a number of manufacturing roles, including at the Ringaskiddy, Ireland site, at Pfizer's New York headquarters, and at the Groton, Connecticut, USA site. In 2003, Mr. Greene was appointed to his current role of Director/Team Leader of Pfizer's API Operations Team. He is founder and co-chair of ISPE's API Community of Practice, and co-chair of the ISPE Community of Practice Council.
Winnie Cappucci, Director - Working in the pharmaceutical industry for more than 38 years, Ms. Cappucci has extensive experience with diverse software and computerized system validation and auditing. She has been a business process owner designing and testing computerized systems, and has worked as an IT professional with thorough knowledge of software development life cycle and computerized system operations and support. For the last 16 years, Ms. Cappucci has worked as a quality and compliance computer validation specialist in a highly regulated environment. She is currently a member of ISPE's GAMP® Americas Steering Committee.
Doyle R. Johnson, Director - Mr. Johnson currently serves as Consultant at CDI Life Sciences, working on Genzyme's Cell Culture Expansion Project in Framingham, Massachusetts, USA. He previously served as Senior Director and Director in the Facilities and Engineering Group at MassBiologics, a MAbs Cell Culture and Fill/Finish Operation in Boston, Massachusetts where he served in a leadership role from initial design through startup/commissioning to FDA licensure, followed by implementation of a CMMS. He has more than 25 years of experience designing, building, and operating biopharmaceutical and chemical process plants. Mr. Johnson has served as president of ISPE's Boston Chapter and has served five years on the Chapter's Board of Directors.
Andrzej Szarmanski, Director - Mr. Szarmanski is Quality Director at Polpharma SA, a European pharmaceutical manufacturer involved in manufacture of non-sterile and sterile pharmaceutical products as well as active pharmaceutical ingredients with headquarters in Poland. He has 17 years of experience in the pharmaceutical industry and has been involved in various production, engineering, and quality assurance roles. He has published and lectured on quality relating topics in Poland and abroad. Mr. Szarmanski has been involved with the ISPE Poland Affiliate since its 1999 inception, having been its Chairman for the last four years, as well as currently serving as Co-chairman of ISPE's European Affiliate Council.
Morten Stenkilde, Director - Mr. Stenkilde is currently Quality Director at Novo Nordisk's insulin filling plant in Tianjin, China. He has more than 15 years of pharmaceutical manufacturing experience in the areas of solid dosage, contract manufacturing, and sterile manufacturing. Mr. Stenkilde has international project experience from Denmark, Brazil, and recently China. He has experience from production departments, quality departments, logistic departments, as well as project management in the pharmaceutical industry. He is also a member of the newly established steering committee tasked with expanding ISPE's offerings in China and working closely with Chinese SFDA inspectors to support the development of the pharmaceutical industry in that region.
Antonio Buendia, Director - Mr. Buendia is currently the Project Engineering Manager for Eli Lilly and Company's Alcobendas, Spain facility. He has more than 15 years of pharmaceutical manufacturing experience in the areas of project management, facilities master planning, facilities and utilities design, solid dosage, liquid dosage, R&D labs (basic chemistry and biological), automation technology, and qualification of facilities, utilities, and equipment. Mr. Buendia is also currently the chairman of ISPE's Spain Affiliate and has been instrumental in doubling the Affiliate's membership, developing an intensive events calendar of high quality events, creating local Communities of Practice, and forming solid relationships with Spanish health authorities.