Our faculty is drawn from among the most experienced professionals in the industry, all of whom have hands-on experience in the biotech/pharma industry.

Instructors/speakers include:

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.

Stephen Chew, Director of Quality Control LIMS, Baxter Healthcare
With over 30 years of experience in Microbiology in a variety of clinical and manufacturing settings, Stephen is currently responsible for all aspects of quality control testing (environmental monitoring, microbiology, chemistry and immunology) and the operation of the laboratory information system. He was responsible for the development and implementation of environmental monitoring systems as an integral part of an isolator based fill line SCADA system. He received his BS in Zoology from California State Polytechnic University, Pomona and completed graduate studies in Public Health at UCLA.


Manuel A. del Valle, Director, HVAC Design, Fluor
Manuel A. del Valle is Director, HVAC Design at the Greenville, South Carolina, USA office of Fluor, a worldwide Design, Build, Construct and Maintenance Company. The bulk of his work has been in HVAC design for Pharmaceutical and Biopharmaceutical Facilities. In 1965 Manuel obtained his BSME degree from the University of Puerto Rico. He is a registered professional engineer in Puerto Rico and six states in the USA. In 1971 he began designing HVAC systems for Pharmaceutical facilities while managing the HVAC design department of Daniel Construction Co. Int'l. in Puerto Rico. In 1987 he began designing HVAC systems for Biopharmaceutical facilities while working for Fluor Daniel in their Greenville, South Carolina office. His design experience includes preparation of conceptual, preliminary, and construction documents of HVAC systems, as well as field supervision and troubleshooting. He has published a number of articles and lectured at various universities and seminars of national and international associations on HVAC design for Pharm/Bio facilities.

John Davis, Principal Engineer, GE Healthcare
John Davis currently works for GE Healthcare as a column expert specialising in large downstream applications and equipment. He has been in the industry for over 30 years designing, building and selling Chromatography columns for the BioProcess industry. John holds a number of patents related to columns with the three way nozzle as an example which has revolutionised the industry related to large column packing, unpacking and cleaning in place.

John was the driving force and designer of the Chromaflow range of columns. He is an active member of ASME BPE sitting on two sub-committees for Design relating to sterility and cleanability of equipment and polymers and elastomers.

Working for R&D in Uppsala, Sales and Service globally, as well as custom design and manufacture, John brings a wealth of knowledge related to downstream processing.
From plant design, specifications, design and build, installation, start up and training.

Jim Erickson, President, Blue Mountain Quality Resources, Inc.
Jim Erickson is President and CEO of Blue Mountain Quality Resources, Inc., a US based developer of calibration, validation and maintenance software for FDA & EMEA regulated life sciences organizations. His role at this firm provides constant contact with the many issues facing life sciences personnel. He has authored articles on calibration, software and GMP compliance. Every year Mr. Erickson presents to hundreds of people at numerous regional and International events. Erickson, who holds Bachelor's and Master's degrees in Mechanical & Bio engineering, is active in ISPE, American Society for Quality, the National Conference of Standards Laboratories and the Measurement Science Conference.

Dr. Kjell Eriksson, Senior Scientist, R&D, GE Healthcare Life Sciences
KDr. Kjell Eriksson is currently Senior Scientist at GE Healthcare. Since 1998, he has held different scientific and managerial positions at Amersham Biosciences and GE Healthcare. His main focus has been on purification of biomolecules, such as monoclonal antibodies, as well as development of chromatography resins and process economy. In his current position, he is responsible for development of processes for monoclonal antibody purification. Previous to GE Healthcare, Kjell worked for JT Baker as Senior Research Chemist.

Kjell received his PhD in Biochemistry from Uppsala University, Sweden, in 1986. He did his post-doctoral training with Monash University, Clayton, Vic., Australia and Indiana University, Bloomington, IN, USA.

Reinhard Hanselka, Principal Chemical Engineering, Integrated Engineering Services
Mr. Hanselka brings over thirty years of Environmental, Hazardous Materials and related Chemical Engineering experience, including an extensive regulatory background focusing on hazardous materials handling, waste treatment and code compliance (e.g., Building, Fire and Mechanical Codes). He is a voting member of several National Code development committees including NFPA 1 and ASME BPE. He is involved in conducting compliance audits, developing regulatory guidelines and performing building occupancy and related chemical process plan reviews. He has spearheaded several hazardous material subcommittees for the Santa Clara County Fire Chief's Association and actively participated on code rewrite committees. Mr. Hanselka also has extensive engineering design experience in hazardous materials and specialty gas systems.

Barbara K. Henon, Ph.D., Manager, Technical Publications, ARC Machines
Barbara K. Henon, Ph.D, Manager of Technical Publications at Arc Machines, Inc. has been an Arc Machines employee since 1984. She has authored numerous articles on orbital welding and was awarded Pharmaceutical Engineering's "Article of the Year" in 1999, and the American Welding Society (AWS) "Silver Quill" award in 1997. She has written many operator training manuals for Arc Machines equipment and was an instructor of orbital welding, training welding operators in the field for many years. She has been an instructor at the ASME Bioprocessing Seminars since 1989, and made presentations to the Society for Bioprocessing Professionals and other industry groups. Dr. Henon received her Ph.D. degree in Biological Sciences from the University of Southern California in 1976 and did postdoctoral work in the Division of Neurosciences at the Beckman Research Institute at the City of Hope until 1984. Dr. Henon is the former Vice Chair of the ASME BPE Main Committee working on the ASME Bioprocessing Equipment (BPE) Standard. She is a long-time member of the ASME BPE Materials Joining and Surface Finish Subcommittees and is presently Chair of the Passivation Task Group of the Surface Finish Subcommittee. She is also a member of the AWS D18 and D10 and SEMI Standards writing groups.

Rolf Hjorth, Staff Research Engineer, Protein Center Department, Research & Development, GE Healthcare
Rolf Hjorth is currently Staff Research Engineer in the Protein Center Department within Research & Development at GE Healthcare, Uppsala, Sweden. Rolf joined the company 1975 and has since then had different scientific and managerial positions in the R&D organization including work on protein expression, protein purification and cell separation. For the last 15 years his main focus has been on development of chromatographic media and hardware for bioprocess applications. In his current position he is responsible for the technical development in the bioprocess application area. Rolf holds an MSc in biotechnology from the Uppsala University.

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.

Eric Isberg, Product Manager, Liquid Pharmaceuticals, Bosch Packaging Technology, Inc.
Eric Isberg is Product Manager in liquid pharmaceuticals for Bosch Packaging Technology, specializing in advanced aseptic processing for product filling operations and in filled product inspection equipment. He has over 14 years of experience working in the areas of biopharmaceutical and pharmaceutical processing. Previously, he worked in the biopharmaceutical industry at PDL Biopharma and Biogen Idec in the areas of equipment and process validation, manufacturing, process development, and technical services. He holds a BA degree in Biology from Gustavus Adolphus College. He is a member of the International Society for Pharmaceutical Engineering (ISPE), the Parenteral Drug Association (PDA) and the American Glovebox Society.

Dr. Günter Jagschies, Director Customer Applications, R&D, GE Healthcare Bio-Sciences AB
Dr. Günter Jagschies holds a Ph.D, in Biochemistry from the University of Münster in Germany. He joined GE Healthcare (GEHC) in 2004 via the acquired former Pharmacia Biotech and Amersham business where he began in 1985 and has held senior commercial, marketing, and R&D management roles. His current position is Director Customer Applications at R&D for GEHC Life Sciences based in Uppsala Sweden, in charge of industrial collaborations and a portfolio of activities to study biopharmaceuticals development workflow as well as the design and economy of manufacturing processes for protein drugs. During his career, he has worked as head of Sales in Europe and of Marketing for the global GEHC bioprocessing business. Prior to that, he has been in charge of R&D portfolio management with focus on industrial separations technology and has run the company’s Fast Trak customer training centre in Europe. His technical experience includes chromatography process design and technology handling, regulatory issues incl. validation planning, and process economy analysis.

Dan Klees, Sr. Industries Manager, Life Sciences, Endress+Hauser. Inc.
Dan Klees is the Sr. Industries Manager for Life Sciences at Endress+Hauser. Inc. located in Greenwood, Indiana. He received his Bachelor of Science and Master of Science Degrees in Physics from Miami University. Dan Klees has over 30 years of experience in this industry, having held management positions in sales and marketing with major instrumentation and automation companies as well as engineering management and executive management positions with integration and engineering firms. He is a member of ISPE and is a member of the ASME-BPE Standards Committee where he Chairs the ASME-BPE Measurement Instrumentation Standards Task Group. Dan has published several automation and advanced control algorithm articles in leading technical journals and has presented papers at International Symposiums. Dan Klees has been a graduate school guest lecturer on process automation at several Universities. Dan holds six (6) patents/patents pending related to hygienic process measurement instrumentation innovations and calibration methods. He is a Certified cGMP Instructor.

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 has 20+ 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 commercial facilities, having served many of the leading international biotech and pharmaceutical firms since 1989. Prior to founding DME Alliance in 1998, he managed the engineering department for Associated BioEngineers and Consultants (ABEC). He is active on the ASME Bioprocess Equipment (BPE) standard main committee, serves on the polymers subcommittee and as vice-chair of the design subcommittee. A graduate of Lafayette College, Mr. Marks holds a BS in Chemical Engineering and is a registered Professional Engineer.

Jerold Martin, Sr. Vice President, Global Scientific Affairs, Pall Life Sciences
Jerold Martin is Sr. Vice President of Global Scientific Affairs at Pall Life Sciences, responsible for technical and regulatory communications. He has over 30 years experience in Validation, Technical Services, R & D, Marketing and Business Development.

Mr. Martin has lectured extensively at biopharmaceutical companies and industry groups such as PDA, ISPE and ASME, as well as at regulatory agencies, throughout the world. He is the author of numerous publications on biopharmaceutical manufacturing and aseptic processing, including co-authorship of the PDA Technical Reports on Sterilizing Filtration of Liquids, Sterilizing Filtration of Gases, and Virus Filtration, the ASTM F838 Standard on Sterilizing Filtration and the ISO Standard on Aseptic Processing, Part II, Filtration. Mr. Martin is also Director and Technology Committee Chair with the BioProcess Systems Alliance (BPSA), where he co-authored the BPSA Recommendations for Component Quality Tests, Irradiation and Sterilization, and Extractables and Leachables from Single-use Systems for biomanufacturing. He is on Advisory Boards for IBC and PDA, where he received the 2007 PDA Distinguished Service Award, as well as on the Editorial Review Boards of American Pharmaceutical Review, Genetic Engineering News, Pharmaceutical Technology Europe and Contamination Control magazines. Mr. Martin holds an M. Sc. in Microbiology from the University of Toronto.

Miriam Monge, Industry Consultant
Miriam was Marketing Director at Stedim Biosystems until December 2007. She joined Stedim in 1994 where she was involved in integrating single-use disposable technology within several new facility & retrofit projects in major biopharmaceutical companies. A key focus area for Miriam has been facility design and process optimisation through strategic implementation of disposable technologies. Much of the work carried out in this area was through a close collaboration with biopharmaceutical manufacturing strategy consultants Biopharm Services.

Miriam is a visiting lecturer at MBI biomanufacturing training courses, University college, London and is a steering committee member for the ISPE sterile products processing community of practice. Miriam has recently led the creation of the ISPE Community of practice for disposable manufacturing of which she is co-chair with Adam Goldstein of Genentech. She has authored & co-authored several papers on single-use manufacturing in journals such as Genetic Engineering News, ISPE Pharmaceutical Engineering, Bioprocess & Biopharm International.

Philip Nelson, Principal Engineer, Amgen Inc.
Mr. Nelson is presently a Principal Engineer in Process Engineering at Amgen Inc. He has more than twenty years of biopharmaceutical experience in the areas of purification process development, manufacturing science and process engineering. Mr. Nelson has worked on the development and scale-up of numerous biotech drugs at Genentech, Connective Therapeutics, Millipore, Abgenix and Amgen.

For the last five years Mr. Nelson has focused exclusively on the troubleshooting, equipment and facility design, technology transfer, scale-up, and process improvements for the large scale purification of monoclonal antibody products. Mr. Nelson holds a BS in Genetics from the University of California at Berkeley.

Alvin W. Nienow, Professor, University of Birmingham, UK
Professor Alvin W Nienow has been a professor at The University of Birmingham, UK since 1980 and is currently Emeritus Professor of Biochemical Engineering. He has a BSc (Eng) in Chemical Engineering (first-class), a PhD and DSc (Eng) from University College London. He is a Fellow of the Royal Academy of Engineering and of the Institution of Chemical Engineers by whom he was awarded The Moulton Medal (1984) and The Donald Medal (2000); also the Jan E Purkyne Medal by the Academy of Sciences of the Czech Republic (1993) and Lifetime Recognition Award for his Contribution to Mixing Research and Practice" by the European Federation of Chemical Engineering (2003). His publications on bioprocessing cover 'shear' effects on animal cells, bacteria, yeast, mycelia and during cell lysis for gene therapy products; the aeration of broths of low viscosity and of complex rheology; the impact of variations in pH, dO2, and glucose on the large scale on bio-performance; and the development of new agitators and agitation strategies.

Professor Nienow is on the Editorial Board of Biotechnology and Bioengineering and currently the Chairman of the Scientific Committee for the Advanced Course on Biochemical Engineering Principles of the European Federation of Biotechnology. He is an editor of the textbook, "Mixing in the Process Industries", now in its 2nd edition and in paperback and translated into Japanese and Chinese. He also consults for many companies in the UK, Europe and the USA and for The Fluid Mixing Processes industrial consortium run by BHR Fluid Engineering.

Ann O’Hara, General Manager, Bioprocess, GE Healthcare Life Sciences
Ann is the General Manager of Bioprocess, a $400m global business which supplies technologies and services to biotech manufacturing, part of the Life Science business in GE Healthcare. Prior to her current role, she has held management positions in GE Healthcare global marketing and GE Corporate in the Corporate Initiative Group, where she led Sales and Marketing Six Sigma projects across GE. Prior to joining GE, Ann was with McKinsey & Company working with industrial clients on strategy, M&A and sales & marketing issues. She has also worked for Procter & Gamble leading product development projects for the laundry and personal care categories in the US, Argentina and China. Ann holds a MBA from Harvard Business School and a BSE in Chemical Engineering from University of Pennsylvania.

Marc Pelletier, Director, Strategic Biopharm Solutions Group, CRB
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.

Jan Rau, QA Manager, Dockweiler AG
Jan Rau has worked in the field of austenitic CrNi steel tube systems for the semiconductor and pharmaceutical industry since 1998. Rau is responsible for Quality Management and R&D with major focus on metallurgy and surface analyses. He received his PhD in co-ordination chemistry of group 6 metal carbonyl compounds from the University of Hamburg. He is a member of the ASME BPE sub-committees on Surface Finish (SF) and Metallic Materials of Construction (MMOC).

Craig Robinson, Technical Director for North America and Europe, GE Healthcare
Craig Robinson has over 30 years of experience of cross functional experience with membrane technology servicing the pharmaceutical industry. Craig holds the position as Technical Director for North America and Europe for GE Healthcare LifeSciences Membrane Separations. Previously, Craig was Director of Sales and Marketing for A/G Technology, bringing this small entrepreneurial company to the leadership position within the field of hollow fiber cross flow membrane separations in the bioprocess industry.

Craig has hosted technical training classes to the pharmaceutical industry to raise awareness of the details of the critical parameters related to both cross flow and normal flow filtration. His practical approach to solving complex application problems has earned him a reputation as a reliable consultant for a wide range of clients involved with membrane based separations. Craig holds a degree in Chemistry from Northeastern University.

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.