Dianna (Kilcoyne) Ambach
Dianna has been working in the biotech industry since graduating with an undergraduate degree in biology. She has experience in many different roles in both the manufacturing and development fields within Genzyme. Most recently, her time has been spent as a member of the Gene Therapy Department as a Principle Development Associate and Cell Culture Manager where her responsibilities include upstream development and optimization of a pilot scale production process. Prior to her work in Gene Therapy Dianna worked in manufacturing as a support technician where her group was responsible for preparing, filtering, and filling of various purification buffers and growth Media. This general process included writing, amending, and following GMP compliant Standard operating Procedures (SOP) specific to each batch of material made.
Dr. Amer is Principal at Premier Compliance Services a Management Consultancy for compliance and manufacturing operations performance in the life sciences industry and adjunct professor of Chemical Engineering at Widener University. As a recognized expert in GMP compliance and validation, he consulted for many of the leading pharmaceutical, biotechnology and medical device manufacturers; also, he has lectured extensively around the globe on a variety of subjects: controlled release technology, GMP trends, validation and change control and implication of GMP compliance on process and facility design in the biotechnology industry.
Tara is a chemical engineer with considerable experience in cell culture, bioprocess development, and process analytical technology, including eight years of industry experience. She is currently a Senior Bioprocess Engineer within the Process Development group at Merrimack Pharmaceuticals. Her work focuses on the scale up, engineering and support of upstream processes for early-to-late stage clinical products, commercial products and next generation products. Her particular areas of interest include new technology development, understanding factors affecting process scale up, process analytical technology and utilization of multivariate analysis, and first principle models. Tara is also actively involved in mentoring grade school and high school students in science, technology, engineering and math fields.
Eszter has more than two decades of experience in the biopharmaceutical industry. Her areas of expertise include biochemical analysis and process development/scale-up of biopharmaceutical processes. Her analytical and preparative protein purification experience and knowledge of related areas was developed with the following companies: STC Biologics Inc. (Co-Founder and Chief Technology Officer); Lonza Biologics Inc. in Portsmouth, New Hampshire (Head of Manufacturing Technical Support--scale-up, process monitoring and improvements, analytical development, biostatistical analysis group); GTC Biotherapeutics, Director of Process and Analytical Development; Ares Advanced Technologies - Serono, Director of Protein Purification; Seragen (currently Lonza Hopkinton Inc.), Manager of Process Development; Medarex Inc., Senior Scientist. Eszter received her M.Sc. in organic chemistry and holds a doctorate in Analytical Immunology from Eötvös University in Budapest, Hungary. She performed post-doctoral research at the University of California, San Francisco and at Purdue University. She has been involved in teaching bioprocessing for several years at community colleges in New England.
Amy graduated from Villanova University in 2005 with her Bachelor's in Chemical Engineering. While working for Abbott Laboratories as a Project Engineer she went on to receive her Professional Master of Science in Biotechnology Engineering. In 2007, she accepted a position with Bristol-Myers Squibb as a Manufacturing Engineer to support the construction, commissioning and validation of the LSCC (Large Scale Cell Culture) Project in Devens, Massachusetts. While in this position she supported inoculum, the seed bioreactors and production bioreactors along with their supporting equipment and processes (including CIP & SIP). She is thrilled to join WPI's BETC team and hopes to both educate and inspire students and employees interested in learning more about biomanufacturing
Eric Duval has a Master of Science in Emergency Management and a Bachelor of Science in Criminal Justice, both from Anna Maria College. He has been working in the biotechnology industry with AbbVie since 2001. He has experience in many areas of biopharmaceutical manufacturing including validation of process equipment, warehouse operations, and process safety. The main area of focus Eric is currently working on is building a positive safety culture within AbbVie Bioresearch Center’s Global Pharmaceutical Operations manufacturing facility. Eric is a senior level Certified Hazardous Materials Manager (CHMM). He served on the board of directors for the Central Massachusetts Business Environmental Network (CMBEN). Eric is an instructor for Quinsigmond Community College in the Techniques in Biotechnology program and WPI’s Biomanufacturing program. Eric a professional member of the American Society of Safety Engineers (ASSE).
Rick is the Sr. Manager of Global Learning and Development at Boston Scientific in Natick, MA. He has over 35 years of experience in the field of training and development supporting a wide range of industries including pharmaceutical, health care, and computer hardware manufacturing technology. Prior to joining Boston Scientific, Rick worked for Bristol Myers Squibb’s (BMS) Large Scale Cell Culture (LSCC) facility located in Devens, MA. As manager, Rick was responsible for regulatory compliance training, personal and professional development, on-going skill development, and for ensuring that the appropriate training technologies and support systems were implemented to support the mission of the Devens LSCC site. Rick also worked for AstraZeneca in Westborough as Senior Manager of Training and Communication for the company’s pharmaceutical supply site. Additionally, Rick served as an internal performance consultant supporting company merger-related activities and for implementing the performance management system across AstraZeneca’s operations functions. Rick worked in a variety of positions during his 17 years at Digital Equipment Corporation (Manufacturing Technician, Training Manager, and Quality Consultant). He has also held positions at Harvard Pilgrim Health Care and Simplex Time Recorder. Rick earned his Bachelor’s degree in Education from Fitchburg State University and his Associates degree from Mount Wachusett Community College.
Muris is currently supporting an expansion project at Bristol-Myers Squibb (BMS) in Devens, MA, representing the client Biologics Development group. He is working with the client to develop requirements, scope, and detailed programming for space and equipment. He is also involved in planning the headcount and budget for startup activities, occupancy, and initial operations. Prior to his current role Muris was the Associate Director of Supply Chain at the BMS Devens site. He has previously held positions in Manufacturing, Manufacturing Technology, and Quality, supporting large scale bio-manufacturing at BMS Devens. Muris received a PhD in Chemistry and Chemical Biology from Cornell University and a BS in Chemistry from Canisius College.
Joanna's specialties include pharmaceutical/biotech/medical device regulations; problem solving, root cause analysis & CAPA; drug product stability; environmental storage chambers; writing/editing procedures & drug product submissions; process development and improvement; record review and documentation practices. Some specific projects include gap analysis against ICH Q10, using risk management to identify high priority recommendations; risk analysis for a Phase III PET drug; developing OJT material and programs for a client's new site; and root cause analysis of process yield issues affecting product supply. Joanna has extensive experience in classroom, e-learning and on-the-job training design, development and delivery, including learning management system implementation and management and strategic planning. She is known for designing, developing and delivering strong, interactive and effective GxP/ISO-related training and was also a co-developer of WPI's Biomanufacturing Certificate Program. .
Don has been in the biotech industry since 1988 performing purification and separation operations. His experience is in both biologics manufacturing and process development. Areas of specific expertise include chromatography, chromatography column packing, direct flow and tangential flow filtration, and aseptic operations. Prior to involvement in the biologics, he was employed as a high school math and science teacher.
Deb Grant is a Training Specialist at AbbVie Bioresearch Center in Worcester, MA with extensive Manufacturing and cGMP experience. Deb has twenty-one years in biotechnology, including ten years in clinical and commercial biologics manufacturing (large and small scale) with extensive technical experience in protein purification, analytical techniques, and aseptic processing, and eleven years in Training, cGMP and related training program design and delivery experience. Deb has a strong working knowledge of cGMP regulations, with specialized skills in SOP writing, technical training, subject matter expert trainer in cGMPs and related topics. She completed a Biotech Certificate Program from Minuteman Vocational Technical School in 1992, one of the first Biotech Certificate programs in the state for manufacturing technicians. Deb worked at Genetics Institute, (now Pfizer, formerly Wyeth) in Andover, MA from 1992 until 1999, working her way up to Supervisor of the Commercial Protein Purification group. Deb moved to BASF in 1999, (now Abbott Bioresearch Center) as a senior technician and then shift supervisor in the Protein Purification group, then moved to the training group in 2002. She has attended courses at Quinsigamond Community College in the Biotech Certificate Program and has a certificate from WPI Bioscience Regulations Management Certificate Program. Deb is a Member and Officer of BETA, Biopharmaceutical Education and Training Association. She is the Lead Instructor and Coordinator for the Quinsigamond Community College Techniques in Biotechnology Class taught at AbbVie. Deb is also an Advisory Board Member for Northeast Biomanufacturing Center & Collaborative and Worcester Technical High School.
Brian Hagopian, CPIP
Brian Hagopian, CPIP is a degreed chemist from Colgate University. He began his biotechnology career in 1977, founded and grew Fluid Solutions from 1989-2006, served as VP of R+D for Mar Cor Purification from 2006-2011, and is currently a subject matter expert, consultant, and trainer in the field of high purity water and waste water treatment with Clear Water Consulting, Inc. Brian is a charter member of the Boston Area Chapter of ISPE. Brian has been the Co-Chair of the ISPE Product Show Committee from 2006-2010 and was instrumental in relocating the Product Show to Gillette Stadium. Brian served as Vice President of the Chapter for the 2010-2011 year and President of the Chapter for the 2011-2012 year. Brian currently leads the Student Chapter Committee. Globally, Brian is a member of ISPE’s Critical Utility COP steering committee and is currently leading a group of experts in producing an ISPE Good Practice Guide on Sampling of water, steam, and process gas sytems. Through participation in a chapter sponsored study group, Brian attained his Certified Pharmaceutical Industry Professional (CPIP) credential in 2012.
Jean-François loves to share his passion for biological and bioprocessing engineering with academic students and professionals. He is a hands-on teacher in MIT’s Chemical Engineering Department and has been an industry consultant for more than 25 years. Jean-François has studied original upstream and downstream problems in varied microbial and cell culture processes, at the bench (down to µL) and pilot scales (up to 1,500 L), and integrated advanced analytical technologies for process improvement. In his teaching and research Jean-François has had the opportunity to beta-test or evaluate novel technologies, such as the first rock-bed single-use bioreactor and portable microbial flow cytometer, in-situ glucose and O2/CO2 optical sensors, auto-samplers, modular analyzers, expanded-bed chromatography, and computer simulation tools. His current projects focus on biofuels from microalgae and yeast, vaccine antigen and monoclonal antibody from mammalian cells, stem cells, and proteins from microbes, which have been studied in traditional or single-use bioreactors. Jean-François received a MS in Biochemical Engineering from MIT, and a PhD from the Pierre and Marie Curie University (part of “Sorbonne Universités”). He is enthusiastic about joining the BETC instructional staff, contributing to the original course offerings at BETC, and working with the course participants.
Roy is a Senior Scientist at the Abbott Bioresearch Center in Worcester involved in protein purification and enzymatic conversion. He works at both the laboratory scale, involving micrograms, and the production scale, involving kilograms, of protein. He has worked in other areas as well: the purification of antibiotic molecules, the development of medical diagnostic devices, the manufacture of continuous fiberglass strands, and the design and operation of chemical plants. Roy's Ph. D. and B.S. degrees in Chemical Engineering are from UMASS Amherst and Lehigh U., respectively.
Angela Johnsen entered the biotech field in 2005 via the Biotechnology Certificate Program at Middlesex Community College. Angela has worked at Glaxo-Smith-Kline and Genzyme Corporation. Angela currently works as a Development Associate in cell culture in the Gene Therapy Development group in the Framingham campus. Although currently in cell culture, Angela has also held positions in laboratory support and assay support.
Kevin holds a BS in Biochemistry and has worked for over 25 years in the Biotech industry. Over the course of his career he has worked for a number of companies including Integrated Genetics, Genzyme, Seragen, BASF Bioresearch Center, Abbott Bioresearch Center and Bristol-Myers Squibb before becoming a consultant. Early in his career he worked in the process development area designing methods for purifying proteins so that they could be scaled up to produce commercial product and also developing analytical methods for determining the concentration and purity of these proteins. Later he moved into a manufacturing role to manage the production of both clinical and commercial products. He has also been part of teams responsible for the design and start-up of two commercial facilities through licensure and is currently consulting with a local biotechnology company on a number of projects they are working on.
Chris started in the biotech industry in 1991 working at a small diagnostic company Cambridge Biotech (CBC) within the Packaging and Labeling Department. A year later Chris then transferred to the Final Bottling Department where he learned proper aseptic practice. Chris Worked at CBC for five years. He later was hired at BASF (which was once Abbott Bioresearch Center and now is ABBVIE Bioresearch Center). Chris started in the glass wash area, and then moved to solution formulation. Ultimately Chris moved to the Cell Culture area where he and the team he worked with were able to assist with the registration of HUMIRA® in 2001. In 2002, Chris transferred to the Quality Assurance Training and Development (QATD). Chris still currently works in QATD as a Senior Site Training Specialist focusing on the training of all Cell Culture and Core Support personnel.
Markus is a manager responsible for both clinical and commercial manufacturing operations in the BioProcessing Operations group at AbbVie Inc., a research-based pharmaceuticals company that discovers, develops, and commercializes advanced therapies. Markus has more than twenty years of experience in the biopharmaceutical industry working for such companies as Lonza and Baxter. Most recently he received an Operations President’s team award for customer service excellence. Markus joined WPI’s Corporate and Professional Education program in 2008 and is an instructor for the Chromatography 1 Module in the Fundamentals of BioManufacturing program.
Christof Schulz has over 12 years’ experience in the Biotech industry. After obtaining his Ph.D. in Biochemical Engineering, Dr. Schulz worked as a Postdoctoral Scientist in Bioprocess Research and Development at Eli Lilly and Company in Indianapolis, IN. In 2003, Dr. Schulz joined the Abbott Bioresearch Center (now AbbVie Bioresearch Center) in Worcester, MA as a Scientist in Process Sciences. At Abbott and AbbVie, he has been holding positions with increasing responsibility, currently as Senior Group Leader of the Process Sciences Scale-up Laboratory.
Ed Smith is an Associate Director of Manufacturing at Bristol Myers Squibb, in Devens MA. He has 15 years’ experience in the biologics manufacturing industry, specializing in large scale fermentation / cell culture. Ed has been an instructor in the WPI Biotech Fundamentals program since 2007
Danielle Thompson Reynolds
Danielle is a highly motivated, self-directed professional dedicated to providing support to biopharmaceutical manufacturing and engineering project teams to drive continuous process improvement. Strong organizational, communication and facilitation skills with keen attention to detail. Danielle has specialties in cGMP, Biologics, Manufacturing Processes, Analytical Testing, Aseptic Processing, Mammalian Cell culture and Instructional design.
Mr. Winnett is a director at Validation Technologies Inc., a provider of validation, calibration and commissioning services to the pharmaceutical, biotechnology and medical device industries. The company offers a full spectrum of services including instrument engineering, systems start-up, computer validation, cleaning and sterilization validation, process equipment and process validation. He has been with the company for ten years and is the Director of Validation and Commissioning. He is responsible for resource allocation, placement coordination, budgeting, compliance and overall management of 20+ employees. He studied Biology at Northeastern University and has accumulated 25 years’ experience developing, executing and directing the validation of manufacturing equipment for small and large scale mammalian facilities, medical devices, cleaning and sterilization processes. He is a member of the ISPE organization and serves his local community through coaching and as a DPW commissioner.