Advisory Board & Select Faculty

MQARS faculty and advisory board members are industry leaders as well as dedicated instructors and advisers. The academic backgrounds of the instructors enable them to lend our classes a theoretical depth, while their hands-on experience ensures that practical knowledge is never shortchanged. The members of the program advisory board review the curriculum to ensure that it meets the highest standards in a rapidly changing professional environment.

Meera Bhatia is a senior research and development quality assurance specialist in Abbott Laboratories' diagnostic division. She supports design and development activities for new product development for diagnostic assays. Bhatia is responsible for ensuring that the activities associated with design control adhere to the requirements established by the regulating body responsible for the market in which the product will be sold (U.S. and/or international). This includes overseeing the design verification (non-clinical) and validation (clinical) studies, review of the submission, and ultimately the transfer of the design to production. Prior to her position in quality assurance, she worked for four years as a technical specialist providing market support for reproductive organ cancer diagnostic assays. She graduated in 1999 with a BS in cell and molecular biology from Northwestern.

Mark Bourgeois is the administrator of the Northwestern site of the VaNTH Engineering Research Center, an NSF project for biomedical educational technologies. In addition to his VaNTH administrative duties, he develops and teaches ethics components of biomedical engineering classes. He has a master's degree in philosophy from Miami University and is a PhD candidate in philosophy at Loyola University Chicago. Bourgeois also holds a BA in philosophy and a BS in physics from the University of Illinois.

Nina Brown is a team leader for Abbott Laboratories, supporting immunoassays for the diagnosis of Toxoplasma gondii, Rubella, and Cytomegalovirus. The focus of this position is on ensuring availability of high quality products that meet customer needs while maximizing profitability through continuous product improvement. Working with cross-functional teams comprising technical, manufacturing, quality and regulatory groups, she aims to resolve technical challenges, and improve product performance and production efficiency while meeting all applicable quality and regulatory requirements. Brown graduated from the University of Illinois at Chicago with a PhD in microbiology and immunology. Upon completion of her doctorate she was an NIH National Research Service Award postdoctoral fellow at Northwestern.

Hilary Godwin, the outgoing chair of Northwestern's chemistry department, began working at Northwestern in 1996 and was awarded the Camille and Henry Dreyfus New Faculty Award. She received a New Investigator Award in the Toxicological Sciences from the Burroughs Wellcome Fund in 1998, a NSF CAREER Award in 1999, a Camille Dreyfus Teacher-Scholar Award in 2000, a Sloan Research Fellowship in 2000, and the Paul Saltman Award in 2001. In 2002 Godwin was named a Howard Hughes Medical Institute Professor.

Cecilia Kimberlin is group vice president of quality, regulatory and compliance for Abbott Laboratories' medical products group. This position provides quality, regulatory, and compliance oversight and strategic direction for the medical product group businesses. Prior to assuming this position, she served as division vice president of quality assurance, regulatory, compliance, audits and medical affairs for the Abbott diagnostics division. Kimberlin received an MS and PhD in microbiology from the University of Oklahoma. She is a senior member of American Society for Quality and a member of Regulatory Affairs Professionals Society.

As Director of Diagnostics R&D Phase Systems in Abbott Laboratories' diagnostics division, Tina Krenc is responsible for the research and development process. She started at Abbott in 1982 in research and development for the hepatitis product lines. Krenc has worked in clinical research, operations support, and gained 10 years of quality assurance experience in multiple quality organizations. She was the project coordinator for developing and implementing a worldwide design control quality system for Abbott's diagnostics division. Krenc is very involved in risk management internal and external to Abbott. She serves as the U.S. Technical Advisory Group delegate to ISO TC212 for the IVD annex of the revision to the ISO 14971 (Risk Management) standard. She has presented risk management to the FDA and at international meetings, and is an instructor for the Association for the Advancement of Medical Instrumentation risk management class. Krenc received a master of science in product development from Northwestern University's Robert R. McCormick School of Engineering and Applied Science in 2006.

Milton Levenberg worked for Abbott Laboratories for 36 years until he retired in 2001. Since the late 1980s Abbott's structural chemistry department has had to maintain facilities, personnel, and procedures in compliance with GLP and cGMP regulations. Levenberg was responsible for overseeing, and often writing, SOPs and conducting training and audits to insure that members of the department and division were in compliance with government regulations. Along the way Levenberg was elected an associate research fellow in Abbott's prestigious Volwiler Society. He received a PhD in chemistry with a minor in physics from the California Institute of Technology.

Alicia Löffler is a professor and the director of the Center for Biotechnology at Northwestern's Kellogg School of Management. She has served on the governing and advisory boards of biotechnology organizations including the Governor's Biotechnology Advisory Council, the CBC BIO Biotechnology Industry Organization, the BIO Emerging Biotechnology Companies Governing Board, the Illinois Biotechnology Industry Association, the Biotechnology Institute, Women's Entrepreneurial Life Science, and Baird Ventures Partners Fund. She is also a board member of and consultant to many biotech start-ups and regional initiatives in the United States, Asia and Europe. She was recently named one of the "Tech 100" stars by Crain's Chicago Business and received the "Women in Black" Award from i-street magazine.

Kerry Long has more than 30 years of experience in the pharmaceutical industry in the areas of quality and regulatory compliance. She spent most of her career at Searle Pharmaceuticals (later part of Pharmacia and then Pfizer), starting as a bench chemist and then serving for a decade as vice president of global quality and compliance. In that capacity, she had responsibility for the design, implementation, and monitoring of quality policies, processes, systems and programs across all stages of the product life cycle - development, technology transfer and product marketing - for U.S. as well as international operations. She also has held the position of vice president, quality, for Baxter International's Renal Division. She is currently a consultant to the pharmaceutical industry. Long holds a BS in chemistry from Saint Mary's College and an MBA from the University of Chicago.

Claude Lucchesi is a recognized leader in analytical laboratory management, with 14 years of experience in industry and 25 years experience in a university environment. His management experience includes positions as spectroscopy group leader at Shell, director of the analytical research department at Sherwin-Williams, and manager of the analytical and physical chemistry department at Mobil Chemical. At present, he is a consulting director of the analytical services laboratory of the chemistry department at Northwestern and senior lecturer emeritus. He is the co-founder and first president of the Analytical Managers Association. Lucchesi has more than 80 publications on analytical chemistry, applied spectroscopy, polymers and coatings, and lab management.

Ellen MacGran is associate director of compliance programs at Kraft Foods. She has more than 25 years of experience in food quality assurance, has taught quality assurance and organizational change management at the graduate and undergraduate levels, and served as a volunteer examiner for the California Baldrige Award. Her educational background includes a BS in chemistry from the University of Tennessee, a master's in psychology from Pepperdine University, and an executive MBA from the Drucker Graduate Management School at Claremont Graduate University.

Andrew Ott joined the Northwestern University Department of Chemistry in August 2006 as director of the Analytical Services Laboratory. He received a PhD in chemistry from the University of Colorado at Boulder, where he studied the atomic layer deposition of thin films. Previously, he worked at Intel as a group leader in development, working on thin film deposition processes. Ott is the faculty director of the MQARS program.

Tracey Rae is a senior scientist in analytical chemistry research and development for Abbott Laboratories' diagnostics division. His responsibilities include test method development and analysis of biological reagents for immunoassay diagnostic products in research phases. Previously, Rae served three years within the operations area of Abbott's diagnostics division, where he was responsible for on-market product quality support from incoming reagents through manufacturing and testing processes. He received his doctorate in chemistry from the University of Iowa, and completed postdoctoral research training on an NIH Fellowship at Northwestern.

Cheryl Chamberlain Roscher is a senior manager of regulatory affairs for medical devices for Fenwal, Inc. (formerly Baxter, transfusion therapies division), where she formulates and implements U.S. regulatory strategy for new product development, including responsibility for negotiating complex regulatory projects throughout multiple phases of clinical development. She is also responsible for assessing the impact of changes to marketed product on global regulatory applications. Roscher has more than 10 years of experience in the pharmaceutical/medical device industry, serving as regulatory lead for complex medical device systems used for the collection of blood components as well as drug solutions and combination devices. She holds a BS in chemistry from Northern Arizona University and received her PhD in neuroscience from Northwestern.

Mark Sheldon is assistant dean in the Weinberg College of Arts and Sciences at Northwestern, college lecturer in philosophy and in the Medical Ethics and Humanities Program of the Feinberg School of Medicine. He has served as adjunct senior scholar at the MacLean Center for Clinical Medical Ethics at the University of Chicago and senior policy analyst at the American Medical Association. He currently serves as adjunct faculty at the Neiswanger Institute for Bioethics and Health Policy at Loyola University Stritch School of Medicine and adjunct faculty and ethicist at Rush-Presbyterian-St. Luke's Medical Center in Chicago. He received his PhD in philosophy from Brandeis University.

Neal Siegel is the chief scientist for Sword Diagnostics Inc. He has more than 20 years of experience in research and development, product development, specification setting, numerical methods and applied statistics, validation quality assurance, and software quality assurance in the medical device field. He is president of the Clinical Ligand Assay Society and serves on several NCCLS/CLSI subcommittees. He has taught an undergraduate course in quality at Northwestern for the past five years.

Fred Stamer is global quality training manager for Kraft Foods. During his 30-year career at Kraft, he has played leading roles in quality management, operations quality, and corporate research and development. His primary areas of expertise are in the microbiology and analytical laboratory, environmental, sanitation, and regulatory affairs. Stamer oversees the quality and food safety website at Kraft and its quality and food safety course and curricular development. He graduated from Western Illinois University with a degree in environmental science.

Siobhan Yeh is principal consultant with Siobhan Yeh Consulting Company. She has more than 22 years experience in the pharmaceutical and device industry, ranging from bench science to GLP/GCP/GMP auditing to plant floor to corporate QA management. As a change champion, she is known for working with all levels to develop quality solutions, integrate quality cultures, and drive projects. Her leadership has produced model quality systems and programs for corporate-wide use. Prior to her independent consulting role, Yeh held management positions at Abbott Laboratories, Pfizer Incorporated, and Pharmacia Corporation. Yeh is an ASQ-certified quality manager, a certified quality auditor, and a certified quality improvement associate.