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Officers:

Chairman: Arthur "Randy" Perez, PhD

Dr. Perez currently holds the position of Director, IT Risk Management and Compliance for Novartis Pharmaceuticals. His responsibilities at Novartis include a wide range of IT Compliance issues, such as GxP, Sarbanes-Oxley, and data privacy. He serves on several global Novartis teams dealing with computer systems compliance issues, and has authored many of the firm's global GxP compliance policies. During his 28-year tenure at Novartis, he has developed a broad range of experience. Prior to his current position he worked as a chemistry group leader in process research, managed a chemical manufacturing process validation initiative, and ran both a GMP training program and a QA validation group for pharmaceutical operations. Dr. Perez earned a BS in Chemistry at MIT and a PhD in Organic Chemistry at University of Michigan.

Dr. Perez was a member of the PhRMA Computer Systems Validation Committee from 1995-1999, and was instrumental in the formation of GAMP Americas when that group started in 2000. From 2002-2008 he was Chairman of GAMP Americas and he has been a member of the global GAMP® Council since 2002. He initiated and led the Global Information Systems SIG, who wrote a GAMP® Good Practice Guide that was published in 2005, and was part of the core team that led the development of GAMP® 5, published in 2008. Dr. Perez has been a speaker and a course leader at numerous conferences in the US and Europe, and has been published in industry journals and textbooks. In 2005 he was elected to the ISPE International Board of Directors, most recently serving as Vice Chairman.

Vice Chairman: Charlotte Enghave Fruergaard, PhD

Dr. Enghave Fruergaard is employed as Director of Technology, Finished Pharma at NNE Pharmaplan in Denmark.

Previously she was manager of sales and marketing and before that responsible for conceptual designs of new pharmaceutical facilities. Dr. Enghave Fruergaard has over 16 years of experience with pharmaceutical projects. She has a broad experience within pharmaceutical manufacturing of sterile products and is a leading expert within isolator and barrier technology and associated sterilisation techniques. Dr. Enghave Fruergaard holds an MSc in mechanical engineering and a PhD in measuring technique. She has international experience from an EU-founded project where she was stationed at Physicalische Technische Bundesanstalt in Germany. During this project, she also earned a PhD degree within metrology.

Dr. Enghave Fruergaard has been a Member of ISPE since 1995, most recently serving as Treasurer on the International Board of Directors. She was the Chair of the Board Working Group on Organizational Restructuring that facilitated the development of ISPE's new strategic plan. She is co-founder of ISPE Nordic Affiliate in 2000, and the Affiliate's past Chairman. She is a member of ISPE Sterile Products Processing COP steering committee as well as on the Editorial Board for the magazine Pharmaceutical Engineering. Furthermore she has been the co-chairman of the annual ISPE "Barrier Isolation Technology Conference" in Europe since 1999.

Treasurer: Damian Greene

Mr. Greene is Senior Director Network Strategy for Pfizer Global Supply in New York. He has a BE in Chemical Engineering from University College Dublin, and an MSc in Chemical Engineering from the University of Missouri at Rolla. Greene began his career with Pfizer as a Production Supervisor at the Terre Haute Indiana site. He has more than 28 years experience in pharmaceutical and fine chemical manufacture, and has worked for Pfizer in a number of operational, financial and strategic roles, including at the Ringaskiddy Ireland site, at the Groton Connecticut site, and at Pfizer New York Headquarters. Greene has served as Chair of the ISPE Community of Practice Council, and as Chair of the API Community of Practice. Greene most recently served as Secretary on the ISPE International Board of Directors.

Secretary: Brian H.Lange PE

Mr. Lange is PMO Operations Director, North American Operations and Merck Consumer Care for Merck & Co., Inc., West Point, Pennsylvania.

Mr. Lange has been with Merck for over 23 years and held leadership roles in Manufacturing, Engineering and Quality. Prior to his current role, he was Director – Quality Engineering supporting the Global Vaccine Operations network. He also spent 12 years in various leadership roles within Vaccine & Sterile Operations Manufacturing.

Mr. Lange has been an active member of ISPE for over 20 years. He is a Past Chairman of the International Board of Directors and served as the Chair of several International Committees - Education, Technical Documents and Chapter Council and currently participates on the Judges' Panel for the Facility of the Year Award. In addition to his work at the International level, Mr. Lange continues to work locally where he is a Past President of the Delaware Valley Chapter and recipient of the Buzz Lange Engineer of the Year Award. He served the Society many times as a course leader and speaker and authored articles for Pharmaceutical Engineering.

Mr. Lange holds a BS in Mechanical Engineering from Villanova University and is a registered Professional Engineer in the Commonwealth of Pennsylvania.

Director: James A. Breen Jr

Mr. Breen is the Vice President of Project Management in Johnson & Johnson's Worldwide Engineering and Technical Operations Group based in New Brunswick, New Jersey. Mr. Breen has worked for J&J for 12 years in roles of VP Engineering, Global Biologics Supply Chain, and as Manager of Engineering & Construction for the Asia Pacific Operations based in Shanghai, China.

Prior to working for J&J, Mr. Breen was employed by the General Electric Company and Hercules Incorporated in both domestic and international assignments.

Mr. Breen is a registered Professional Engineer and LEED AP. He has a Bachelor of Engineering from Stevens Institute of Technology, a MBA from Drexel University, and a Masters of Engineering in Technology Management from the University of Pennsylvania / Wharton School.

Mr. Breen is an Adjunct Professor with the Drexel University in the departments of Engineering Management and Construction Management. Mr. Breen is also on the Board of Directors for the NJ Arthritis Foundation.

Mr. Breen is the immediate Past President of the ISPE New Jersey Chapter, a member of the ISPE FOYA (Facility of the Year Award) judging team, and a member of the Society's Marketing Advisory Council.

Director: Joe Famulare

Mr. Famulare is a Senior Director for Genentech, Member of the Roche Group, based in Washington, DC. In that role he interacts with various groups and health authorities on quality and compliance matters and provides subject matter expertise on key quality and compliance strategic activities in the Roche Pharma Technical Global Quality organization.

Prior to joining Genentech, Joe worked for the US Food and Drug Administration for 32 years. Joe began his career with the FDA in 1977 as an investigator in what was then referred to as the Newark District. Since then Joe has held key leadership roles within the FDA, including Branch Chief, Case Management and guidance Branch DMPQ, OC, CDER, Director of Manufacturing and Product Quality, CDER Office of Compliance and most recently Deputy Director, CDER Office of Compliance. In CDER, Joe was one of the founding members of the CGMP for the 21st Century Steering Committee and then the Council for Pharmaceutical Quality. He was a leader of the Quality Systems Work Group and Part 11 Work Group. He led many international negotiations and was involved in agreements with EMA, EU member states, Japan, Australia and many other regulatory partners. He actively worked on the International Conference on Harmonization (ICH), representing FDA in various capacities since the ICH quality vision was put in place in 2003.

Joe is well known for being involved in many difficult cross-center and agency compliance cases involving major regulatory actions, meeting the need for medically necessary products, and putting in place corrective action plans. Joe received numerous FDA and Center level awards during his career including the FDA Distinguished Career Service Award.

He has served in many capacities in ISPE over the years, first as a regulator participating in ILF, RAC, PQLI events, and speaking at many conferences globally. Since moving into the pharmaceutical industry he has been active in these same areas serving on the Regulatory Affairs and PQLI Committees, and has launched an effort to co lead in the area of Pharmaceutical Quality Systems for PQLI.

Director: Tim Howard, CPIP, PE

Mr. Howard is a Vice President and Company Officer at Commissioning Agents, Inc., responsible for the Commissioning and Validation services business unit. His responsibilities include maintenance and implementation of the internal quality system, hiring, training, and professional development of resources, and oversight of all major projects.

Mr. Howard is a member of the Society's Future Visioning Team that has helped chart ISPE's near-term course. He is Chair of the ISPE University Committee, chartered with establishing ISPE’s professional development curriculum, and co-Chair of the C&Q COP. An ISPE member since 1994, his service to ISPE includes Chair of the Carolina/South Atlantic Chapter (CASA) membership committee and as a CASA Chapter board member. He is a long-time member of ISPE’s North American Education Committee, having served as Chair and Co-Chair for three years and as a member of the committee since 2002. Mr. Howard was a member of the ISPE Task Team that developed the ASTM standard E2500 on science and risk base qualification and a contributing author to ISPE Guidance Documents on ASTM E2500 Implementation. Mr. Howard is a qualified trainer for the ISPE training course on C&Q applications, regularly speaks at conference seminars worldwide, and is published in Pharmaceutical Engineering. Mr. Howard is a former naval nuclear submarine officer, and was previously licensed as a senior reactor operator on a commercial nuclear power plant. Mr. Howard earned a BS degree in Mechanical Engineering from North Carolina State University, is a Certified Pharmaceutical Industry Professional (CPIP), and a registered professional engineer. Mr. Howard has recently attended leadership training at the Harvard Business School, Financial and Accounting training at Owen School of Management (Vanderbilt), and Strategic Leadership training at the Center for Creative Leadership.

Director: Doyle R. Johnson

Mr. Johnson is the New England Operations Leader for Hargrove Engineers + Constructors. Previously he was the Senior Director of Facilities Operations at Genzyme’s Biologics Division. He has more than 25 years of experience designing, building and operating BioPharma and Chemical Process Plants. Mr. Johnson served as President of the ISPE Boston Chapter, and prior to that served for five years on the Board of Directors of the Boston Chapter. Under his leadership the Boston Chapter implemented a Young Professionals Initiative, a GAMP program at the Product Show and won the Chapter Excellence award for North America. He has lived and worked in both the US and Europe. He holds a BS degree in Chemical Engineering from Cornell University, an MS in Organic Chemistry from Northeastern University and an MBA from Babson College.

Director: Gordon Leichter, PhD

Dr. Leichter is currently a Regional Sales Manager for Belimed Infection Control, focusing on providing sterile processing equipment to the pharmaceutical manufacturing industry. He has over30 years experience within the pharmaceutical industry manufacturing and marketing processing equipment. Leichter has been an active member of ISPE throughout his career, serving on a number of Chapter boards, giving technical presentations, leading seminars, writing articles, participating and chairing various committees, as well as holding a leadership role on the 2006 Facility of the Year winning team. Currently he is the President of the New Jersey ISPE Chapter, Chair of the Sterile Products Processing (SPP) COP; and past-chair of the ISPE Body of Knowledge Committee. He holds a BS in Operations Management and a MS in Management from Thomas Edison State College, and a PhD in Business Administration from TUI University.

Director: Andrew D. Skibo

Mr. Skibo is the Executive Vice President of Operations at MedImmune. In this role he is responsible globally for Manufacturing Quality, GxP Compliance, Sourcing and Supply Chain, Engineering, EH&S and Facilities Operations. MedImmune's sites include live attenuated virus vaccine bulk production in Speke, UK, vaccine fill and finish operations in Philadelphia, Pennsylvania, large scale MAB drug substance production in Frederick, Maryland, non-vaccine fill and finish operations in Nijmegen, Netherlands and commercial distribution operations in Louisville, Kentucky. Mr. Skibo joined MedImmune as Senior Vice President, Engineering in December 2007. He was responsible for overseeing large-scale capital projects at all of MedImmune’s facilities as well as the ongoing construction of the company’s antibody-manufacturing facilities.

Previously, Mr. Skibo held the position of Vice President, Corporate Engineering and Capital Projects at Amgen, Inc., responsible for restructuring and rebuilding the corporate engineering function on a global level. Before joining Amgen, Mr. Skibo served in engineering management positions focused on pharmaceuticals and bioscience at Skanska, Inc.; Foster Wheeler Corp.; Life Sciences International, Inc.; A.D. Skibo & Associates, Inc.; and Genentech, Inc. He held management and technical positions in Development at Monsanto earlier in his career.

Mr. Skibo is a member of ISPE's Facility of the Year Judging Panel and the International Leadership Forum (ILF). He holds a Master of Science degree in Chemical Engineering with a specialty in Biomedical Engineering and a Bachelor of Science degree in Chemistry, both from the Massachusetts Institute of Technology.

Director: Morten Stenkilde

Mr. Stenkilde is currently Quality Director, Insulin Filling plant, Tianjin, China, Novo Nordisk A/S. He has more than 15 years of pharmaceutical manufacturing experience in the areas of solid dosage, contract manufacturing, and sterile manufacturing. Stenkilde has been part of construction projects for both solid dosage and sterile manufacturing with international project experience from Denmark, Brazil, and currently China. He has experience from production, quality, and logistic departments as well as project management. He has been assigned to the construction of Novo Nordisk A/S facilities for insulin filling in China. Stenkilde is a member for the newly established Steering Committee for ISPE Greater China Affiliate. He is developing the Community of Practice for sterile manufacturing in China and actively developing and implementing strategies for the Affiliate.

Mr. Stenkilde is a member of the newly established Steering committee for ISPE Greater China. He gave a speech to the Chinese FDA's inspectors to support development of the pharmaceutical industry in China. He is hosting the COP for Sterile Manufacturing in China and is participating actively in developing and implementing strategies for ISPE Greater China.

Director: Steve Tyler

Mr. Tyler is a Director Analytics and Technical Projects in Global Pharmaceutical Operations at Abbott Laboratories, a worldwide-diversified health care company, in Abbott Park, Illinois, USA. He received BS degrees in Applied Biology and Chemical Engineering from the Georgia Institute of Technology, and an MS in Microbiology from the University of Georgia. Mr. Tyler began his career with Abbott 27 years ago and has experience in drug substance, pharmaceutical and agricultural products manufacture. He has worked for Abbott in a number of operational, strategic and technical roles. Most recently, Mr. Tyler joined the Strategic Quality and Technical Operations organization in 2008. He has served on the ISPE PQLI® control strategy team since 2007 and currently serves on the PQLI Management Committee and co-chairs the PQLI Technical Committee. Mr. Tyler has been a member of the ISPE International Board of Directors since 2008.

Director: Udo Vetter

Mr. Vetter currently holds the position of Chairman of the Control Board of the Vetter Group of companies, a specialty CMO. He serves on the Board of Gerresheimer AG, a major glass supplier to the pharmaceutical industry. He has also been serving for 16 years as a member of the Board of Gland Pharma, India. He manages a privately held investment company called UV-Cap GmbH & Co. KG. Furthermore, he serves as chairman of the trustees of a German University, Sigmaringen-Albstadt.

During his 39 years in the pharmaceutical industry he spent seven years with Schering-Plough in the United States and Puerto Rico and is by profession a US pharmacist.

Mr. Vetter was co-founder of ISPE's German-Swiss-Austrian Affiliate in 1991 and served three years as the Affiliate Chair. In 2002-2003 and 2008 he participated in the ISPE strategic planning sessions in New York as well as in numerous review sessions in Florida.

He has been a member of the International Leadership Forum (ILF) for the last 15 years, as well as ISPE's Future Visioning Team that has helped chart the Society's near-term course.

Director: Guy Wingate, PhD

Dr. Wingate is currently Vice-President & Compliance Officer for Global Manufacturing & Supply at GlaxoSmithKline and has 20 years of experience working in the pharmaceutical industry. At GSK he has held several roles including overall responsibility for quality for one of GSK's largest manufacturing sites, responsibility for QA Technology Strategy, leading a major revision to the GSK corporate Quality Management System, and overall responsibility for Computer Compliance standards and implementation. Dr. Wingate has been involved with the GAMP COP for 17 years in various capacities; most recently he has chaired its governing body GAMP Council 2000-2010 and led the Task Teams producing GAMP^®4, GAMP^®5 and the GAMP^® Good Practice Guide on Compliant Electronic Records and Signatures. Currently he is Co-Chair of ISPE's Task Team writing a new ISPE Guide for the Science and Risk-Based Approach for the Specification, Design, and Verification of Facilities, Utilities, and Equipment Systems which is based on ASTM E55 principles. Wingate was elected to the ISPE International Board of Directors in 2008. He is a Chartered Engineer and holds a BSc, MSc, and PhD from University of Durham in computing, advanced electronics, and engineering science respectively. He is widely published in journals and books, and regularly chairs and speaks at conferences in the US and Europe. Dr. Wingate is also Visiting Lecturer for the University of Manchester's M.Sc. course on Pharmaceutical Engineering Advanced Technology (PEAT) and Dublin Institute of Technology's accredited M.Sc. course on Validation Sciences.

Past Chairman: Andre Walker, CPIP

Mr. Walker is Director of Manufacturing Sciences for Biogen Idec's Manufacturing Operations in Cambridge, Massachusetts. He recently worked in Biogen Idec's Large Scale Commercial Manufacturing Operation in Hillerod, Denmark, where he was responsible for the maintenance and engineering support of all equipment and utilities, including the metrology and validation functions. He has over 30 years of experience in process development, scale-up, implementation, validation, and manufacturing support. A chemical engineer by training, his efforts as principal process development engineer won a Corporate award from Duracell International. At Bayer Diagnostics, Walker formed and staffed a new engineering department, oversaw IVD daiagnostics manufacturing, and was heavily involved in designing their validation and compliance systems. A member of the ISPE International Board of Directors since 2003, he most recently served as Chairman. He is leading the effort to modify the ISPE business model so that the multitudes of assets within the organization function seamlessly to create member value. His past contributions to the Society include four years on the North American Affiliate Council, two of which he served as chair, and several years on the Boston Area Chapter Board, including terms as vice president, program chair, and president. Walker also holds a CPIP credential.

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