Jay Ankers, Director, Process Mechanical, LifeTek Solutions
Jay Ankers is Director, Process Mechanical at LifeTek Solutions, based in Blue Bell, Pennsylvania. He received his Bachelor of Science in Building Science & Construction Management, from Clemson University-College of Architecture. Jay brings seventeen years of active experience in biotech and pharmaceutical projects from concept through operations. Experience includes: project management, construction management, facilities turnover/commissioning, plant engineering, and CIP / SIP testing. Broad experience in management of overall facility and process design and layout, as well as process/utility equipment, piping, instrumentation, control systems, electrical, HVAC, civil engineering, and permitting. He also offers experience related to solid oral dosage, fill & finish, potent compounding, food-grade fermentation, drying, dust collection and powders handling.

Jay is a recognized leader in several ASME-BioProcessing Equipment (BPE) Standard Committees, leading the development of industry approved process technologies and practices. He currently chairs the ASME BPE Subcommittee on Design.

Robert Barloga, Senior Application Engineer, Alfa Laval, Inc.
Robert Barloga is a Product Support Manager for disc stack centrifuges at Alfa Laval, Inc., a worldwide leader in centrifugal separation. Robert is recognized as a leader in the field of centrifugal separation, especially in the application of disc stack centrifuges within the Life Science industry with 19 years of centrifugal separation experience, including centrifuge sizing, selection, and configuration, field testing and start-up of centrifuges within the Bio-pharm industry, centrifuge module design, and supporting the R&D of new centrifugal designs. Robert holds a BS in Aviation Management, and an Airframe and Powerplant license from Lewis University.

Daniel Bauer, Partner, JW Rew Co.
Dan Bauer is a Partner with JW Rew Co., focusing on optimizing filtration process ROI through lean integration, technology selection, value analysis and test methodologies. Prior to recently joining JW Rew Co., Dan was Business Development Manager with GE Healthcare for 3 years, where he led product development teams, was a key member of an integration team for a major acquisition, and key member of the GEHC/Novavax Vaccine Collaboration. Dan’s experience also includes 12 years as a field specialist in bioprocessing with Pall Life Sciences following and prior to its acquisition of Gelman Sciences. During his career, Mr. Bauer has developed several disposable focused filtration product lines, led cross function teams on development of membrane strategies, has been an instructor on numerous filtration seminars, has helped clients optimize hundreds of filtration process streams and has served as an officer with the Capital Area Chapter of PDA. He holds a BS in Marine Sciences from the University of South Carolina and an MBA from Mount St. Mary’s University.

Tim Breece, Development Engineer, Genentech
Tim Breece received his BS in Chemical engineering from the University of California at Berkeley. He has worked for Genentech since 1984. Tim started in manufacturing and in 1988 he transferred to Recovery Process Development, then in 2005 transferred to technology assessment within Process Development. He has specialized in chromatography development from both mammalian and bacterial cell feedstocks. In addition to laboratory development, he has scaled up and transferred several processes to manufacturing sites in the United States and Europe.

Charles Crosier, Senior Project Manager – Capital Projects, Diosynth Biotechnology Services, Inc., a part of Schering Plough Corporation
Charles is currently a Senior Project Manager within the Project Engineering Department at Diosynth Biotechnology Services, Inc. (a part of Schering Plough Corporation) in Research Triangle Park, North Carolina. He has 16 years of experience related to process and project engineering as well as procurement, commissioning and validation activities within the biotechnology and pharmaceutical industries. His project management experience includes simple equipment purchases to multi-million dollar facility upgrades and utility modifications. He has a Bachelors of Science Degree in Mechanical Engineering from The College of New Jersey, a Masters of Business Administration (MBA) from North Carolina State University and the Project Management Professional (PMP) Certification from the Project Management Institute (PMI).

Ken Hamilton, Director of Process Engineering, Genentech, Oceanside, CA
Ken Hamilton has over twenty years experience in the biopharmaceutical industry. Currently, he is the Director of Process Engineering and Automation at the Oceanside manufacturing site for Genentech. His responsibilities include process design, optimization and improvements to manufacturing process equipment at the site. In addition, he is responsible for the process engineering and automation from design conceptual through designed design, installation and start up for new processes that are transferred to the site. Prior to this, he was responsible for engineering technology, which involved development of models to assess manufacturing capacity and risk analysis applied to process equipment.

Prior to joining Genentech, he was a Director of Engineering at Biogenidec. There he led a team to design, construct and qualify a clinical and product launch mammalian cell bulk manufacturing facility. On completion of this project, he took a manufacturing technology assignment for a new manufacturing facility for Biogenidec to be constructed in Denmark.

Ken Hamilton has a Ph.D. in Chemical Engineering and has made fifteen papers / presentations to ASME, ISPE and AIChE. He has chaired several technical sessions for ISPE and ASME in the past.

Barbara K. Henon, Ph.D., Manager, Technical Publications, ARC Machines
Barbara K. Henon, Ph.D. is a Manager of Technical Publications at Arc Machines, Inc., a manufacturer of orbital GTA tube and pipe welding equipment. Barbara specializes in orbital welding of thin-wall tubing and components for biopharmaceutical process piping applications. She has over 15 years experience training orbital welding operators and engineers in the field for pharmaceutical and semiconductor high purity applications. Barbara is a seasoned technical writer on applications of orbital welding. Her honors include Pharmaceutical Engineering’s "Article of the Year" in 1999 and the American Welding Society’s (AWS) "Silver Quill" award in 1997. Barbara holds an AB in Zoology, from Mt. Holyoke College, an MA in Zoology from Columbia University, and a Ph.D. in Biological Sciences from the University of Southern California. Her postdoctoral research was in the Division of Neurosciences, City of Hope Research Institute. She is the former Vice Chair of the ASME Bioprocessing Equipment (BPE) Main Committee and is a current member of the BPE Materials Joining and Surface Finishes Subcommittees. She is also active on the AWS D18 and D10 Standards writing committees.

Mark Herr, Sales/Product Manager at Stainless Technology
BSCE from University of Missouri - Rolla in 1979. 28 years of ASME vessel design, Project Management, Sales Management experience in all industries with specific emphasis on BioPharm applications over the past 23 years. Currently Sales / Product Manager at Stainless Technology which is an ASME Vessel manufacturing company dedicated to the supply of vessels to only the BioPharm Industry.

Matt Hofacre, Director Customer Applications Management, STERIS Corporation
Matt has 10 years experience in pharmaceutical production equipment industries. He is currently the Director of Customer Applications Management at STERIS Life Sciences. Matt is responsible for design applications, project maintenance, and technical guidance for STERIS Finn-Aqua GMP Steam Sterilizers, Multiple-Effect Water Stills, Pure Steam, Generators, and, Reliance and HAMO Pharmaceutical Grade Washers, and AMSCO Sterilizers. Matt was previously an Application Engineer at Osmonics, Inc., Minnetonka,MN (Now GE Water Technologies) where his primary responsibilities included specification and application of high purity water systems including Reverse Osmosis, Deionization, Ozone Treatment, and Distillation for high purity water applications.Matt holds a B.S. in Chemical Engineering from the University of Cincinnati, an MBA from Cleveland State University and is a professional member of PDA, LAMA, and ISPE.

Wei Huang, Director of Process Engineering, Fluor Enterprises, Inc.
Wei Huang is a director of process engineering at Fluor Enterprises, Inc. She brings more than sixteen years of experience in the biopharmaceutical facility/equipment design, process development, operation support and biochemical research. During her career, she has led multiple major projects with biopharmaceutical clients such as, Amgen, Genentech, IDEC, Novartis, Baxter, Novo Nordisk, Elan, etc. Ms. Huang has extensive experience in areas of fermentation, cell culture, cell harvest, downstream purification technologies, aseptic fill and finish operation, clean and plant utilities. She holds an MS degree in Chemical and Biochemical Engineering from University of Maryland. Ms. Huang is a frequent speaker at various biopharmaceutical conferences and technical events. She is an award winner at ISPE publication and a member of ASME BPE subcommittee on design relating to sterility and cleanability of equipment.

Sean Illig, Deputy Director, Process Engineering, Sanofi Pasteur
Sean Illig has over eleven years of experience in the vaccines, biotechnology and pharmaceutical industry in the fields of process engineering, commissioning and qualification. Mr. Illig is currently the Process Engineering Manager with sanofi pasteur where responsibilities include oversight of design and improvements to existing process equipment as well as responsibility for process engineering for all phases of design, installation, commissioning and qualification for new processes / projects at the Swiftwater, PA facility. Previous employment includes CRB Consulting Engineers and Jacobs Engineering. Mr. Illig is an active member of ISPE and AIChE and holds a Bachelor of Science in Chemical Engineering from the University of Maryland.

Paul Kubera, Vice President, Engineering, ABEC, Inc.
ABEC, Inc. is a designer and manufacturer of bioreactor, fermenter and associated systems for the biotech and pharmaceutical industries. Paul brings over 25 years of experience in process and product development, project management and technology transfer to leadership of ABEC's engineering team. Before joining ABEC in 2003 he led Lightnin's application technology and mixing research groups. With a background and on-going involvement in biological processes, he has been instrumental in providing clients with improved knowledge, understanding and performance of the mixing-related operations that lie at the heart of microbial reactor systems. Paul is an active member of ASME BPE sub-committees, task groups and technology transfer course offerings on bioprocess equipment design, working to translate industry needs into relevant standards and delivering this information to a global audience. He is a member of the North American Mixing Forum and has been a presenter and session co-chair at AIChE technical meetings. Paul is a graduate of Cornell University with a Bachelor of Science and Master of Engineering in Chemical Engineering.

Jeffrey Mahar, Director of Sales, CUNO Healthcare Group/a 3M company
Prior to joining CUNO, Mr. Mahar served as Product and Marketing/Sales Manager involving chromatography and centrifugation separations for the Healthcare Industries for nine years at Dorr-Oliver and Biotage. Prior to this, Mr. Mahar was a Process Development for 5 years at Genencor in Rochster, NY. Mr. Mahar serves as a main committee member for the ASME Bioprocess Standards. Jeff has both B. S. and M. S. degrees in Chemical Engineering from Rensselaer Polytechnic Institute and an MBA in International Business and Marketing from the University of Connecticut.

David M. Marks, President and Founder, DME Alliance Incorporated
David M. Marks is president and founder of DME Alliance Incorporated. He has 25+ years of experience in the specification, design and implementation of process systems. He is a frequent author, speaker and consultant on bioprocess technology, facility/equipment design & compliance topics. His professional experience is concentrated in the design and implementation of bioprocess systems for FDA-licensed facilities, having served many of the leading international biotech and pharmaceutical firms since 1989.

Prior to founding DME Alliance in 1998, David managed the engineering department for Associated BioEngineers and Consultants. He is active on the ASME Bioprocess Equipment (BPE) standard main committee, serves on the polymers subcommittee and is currently vice-chair of the design subcommittee. A graduate of Lafayette College, David holds a BS in Chemical Engineering and is a registered Professional Engineer.

Steven Meier, Senior Engineer, Genentech, Inc.
Stephen has over 14 years of experience in cell culture process development and scale-up. He has a BS in chemical engineering from the University of Minnesota and a Ph.D. from the Massachusetts Institute of Technology. Recent experience includes process development, scale-up, validation, and process transfer for post-approval process changes; bioreactor design, facility design, and start-up for a pilot plant; and bioreactor and automation design for a major manufacturing facility.

Philip Nelson, Scientist, Amgen
Philip Nelson has spent the last 21 years working on the production and process development of large scale, recombinant pharmaceuticals. In that time Mr. Nelson has worked at Genentech, Connetics, Millipore, Abgenix and Amgen. He is currently responsible for a Process Engineering group performing facility and equipment design, process improvements and manufacturing non-conformance investigations for Amgen’s monoclonal antibody production in Fremont California. Mr. Nelson received his B.S degree in Genetics from U.C. Berkeley.

Marc Pelletier, Director, Strategic Biopharm Solutions Group (SBSG), CRB Consulting Engineers
Marc is Director of the Strategic Biopharm Solutions Group at CRB Consulting Engineers. The Group specializes in strategic planning, conceptual design, process engineering, risk assessment, compliance and validation for the Life Technologies. Before joining CRB, Marc was President of MPP BioDesigns, a consulting group also specializing in Bioprocessing. Although Marc is formerly trained in biochemistry, he has worked as a process engineer for most of his 25+ year career, all in the food and pharmaceutical and biotechnology sectors. Prior to consulting, Marc spent the majority of his career as an end user developing bioprocesses. His role on various projects include that of project manger, fermentation and downstream process design lead, equipment designer, facility designer, risk assessment moderator and validation manager. He is currently the vice-chair of the Seals Committee for the ASME BPE and is a member of the ASME BPE Main and Design Committees. He has served as adjunct professor at the University of Manitoba, Canada and Bemidji State University, MN. He is a frequent lecturer for the SBP, ASME CEI and ISPE.

Alan Powell, Associate Director for Engineering, Process Engineering, Merck & Company, Inc.
Alan has worked for Merck &Co., Inc. for over 20 years in process development, technical support, and process engineering for sterile and biological products. He has developed sanitary and sterile design guidelines for Merck. He is responsible to mentor other engineers and review designs to ensure adherence to good design practice in new installations for bulk biological products and sterile filling areas. Over the past two years, he has been involved in bulk vaccine facility projects at Merck's plants in Pennsylvania and Virginia and in India; and sterile filling projects at Merck's plants in Ireland, the Netherlands, North Carolina, and Pennsylvania. Alan is also the technical lead for Merck's bioreactor equipment and CIP designs. He also serves as an expert adviser to technical and operating groups in troubleshooting cleaning, sterilization and processing. He holds a B. S. in biochemistry and an M. S. in chemical engineering from Michigan State University.

John Vitti, National Sales Manager, Sanitary Diaphragm Valves Division, Crane Saunders
John Vitti is the National Sales Manager - Americas for Crane Saunders sanitary diaphragm valves and Crane ResistoPure sanitary hoses. He has held this position since March 2001 when Crane acquired Saunders from Alfa Laval. He is also responsible for the Northeast territory in supporting the New England distributor channels at end users, OEMs and Engineering firms for valve and hose product approvals and specifications. Prior to his joining Crane he worked for a ball valve company called SVF Flow Controls as the Northeast Regional Manager for 5 years. This position entailed selling both industrial and high purity ball valves – manual and automated. His main focus was primarily geared towards the pharmaceutical industry since the location of many of the end users and engineering firms are within a radius of 100 miles of the Philadelphia area. He also held the position of Northeast Regional Manager for Keystone Valves for 6 years selling industrial butterfly valves. And prior to Keystone, he was employed by ITT Engineered Valves (diaphragm valves) in various positions for 12 years.

James Dean Vogel, PE, President, Process Facilities Services Inc.
James Vogel is the President of Process Facilities Services Incorporated, a consulting firm focused on all areas of biopharmaceutical and utility engineering and how they best support the manufacture of a product. He has more than 25 years experience in the biopharmaceutical, food and cosmetic industries. He has worked as a Director, Project Manager, and Engineer (Plant Support, Process Development, Project and Automation), with Amgen, GlaxoSmithKline, ImClone, Sanofi-Pasteur, Lipton and Avon. Mr. Vogel is a member of the ASME BioProcess Equipment Standard Committee, leads the Rouge and Seal Performance Task Groups, and is a member of the ISPE North American Education Committee. He is a licensed professional engineer in NJ, and he has a ME in chemical engineering and a BS in biochemical engineering.