Our Advisory Board
Program Coordinator
Judith Fitzpatrick, Ph.D. is the former Founder and President of Serex Inc. a biotech Company that developed (she holds 9 U.S. patents) and manufactured clinical diagnostic reagents and tests.As the former president of an FDA approved manufacturing facility Dr. Fitzpatrick is acquainted with implementing the Quality Assurance measures required by the FDA and well aware of the dependence of regulated companies on the selection and training of their employees and of the costliness of the training process.Dr. Fitzpatrick has developed products for Novartis, Bayer, Medisense (Johnson & Johnson), Bristol Meyers Squibb, Hologic etc.Since 2004, she has been teaching at Bergen Community College. In 2008 she was appointed Assistant Professor with the mandate to initiate and develop a Quality Assurance Program at Bergen Community College that meets the needs of the regulated industries which are such an important part of New Jersey Industry.
Board Members
Hafeez Ansari, Ph.D., is former V.P. ofTechnical Affairs for Quest International, the Mount Olive, New Jersey division ofImperial Chemical Industries (ICI), a >10 billion dollar company based in the U.K.Quest International operates in 30 countries employing 3,500 persons in the fragrance and flavor industry.The flavor and fragrance (personal care industries) operate under GMP and GLP guidelines. In addition to his experience in research (he holds over 30 patents), quality control and safety issues of products, Dr. Ansari brings to the committee a businessman’s understanding of the value of this program to the Jersey based industries.He has pledged his commitment to developing the internship and employment program by networking within the flavor, fragrance and food manufacturing industries of Northern New Jersey.
Steve Mottolo is V.P. of Operations of Genzyme Corporation, a Pharmaceutical and Chemical Company with yearly sales of over 1 Billion.Mr. Mottolo heads the Ridgefield Park Division which manufactures pharmaceutical injectables.He is a national leader in safety and quality assurance and in 2000 his plant won the National Award for Quality Assurance.Steve has agreed to participate in this program because he, like others, is excited that it is the first of its kind and is so needed.He has offered to train interns and look to our graduates for his future employees.In addition Genzyme has a reputation for investing in the community.Steve brings hands-on input on actual manufacturing training.
Joel Lipset is Global Head of the Instrumentation Laboratory Inc, Quality Assurance, Worldwide Compliance and Product Integrity.IL is part of the Werfen Group a worldwide corporation with 2007 sales of over 1 billion dollars that manufactures and distributes in vitro medical diagnostic solutions, medical devices and scientific instruments.Mr. Lipset operates out of their plant in Orangeburg, N.Y. but spends much of his time abroad.Instrumentation Laboratory is a world wide leader in Clinical Chemistry Analyzer Systems.In addition to his qualifications in Quality Assurance, Mr. Lipset is a skilled project manager who will assist us in directing programs for development of this skill in the biopharmaceutical area.
Eugene Reilly is Manager, Pharmaceutical Sciences Quality with the Pharmaceutical Sciences Department of the Schering-Plough Research Institute where he manages a group that facilitates the provision of investigation medicinal products for clinical trials in the European Union and other regions of the world. Mr. Reilly is an acknowledged expert in the development of quality standards for brand name, generic, and over-the-counter pharmaceutical products. His career has included management and quality leadership roles at Merck & Co., Glaxo SmithKline and Schering-Plough, as well as managing his own consulting and testing business. Mr. Reilly has led analytical laboratory operations, conducted quality audits of vendors and suppliers, and developed training programs for laboratory and quality assurance personnel. His industry contacts and hands-on, practical knowledge of pharmaceutical manufacturing, testing and quality assurance will uniquely enhance the program.
Thomas Davis, DVM, Ph.D. is a consultant in pharmaceutical toxicology and drug safety. He was previously Director of Toxicology at Schering-Plough Research Institute, where he managed drug development programs for many products, including Zetia, Noxaphil and PegIntron. As part of the successful efforts to gain approvals for these drugs, he has had extensive interactions with drug regulatory agencies throughout the world. His management responsibilities included the maintenance of laboratory quality standards in compliance with FDA Good Laboratory Practices (GLP) regulations. He continues to advise pharmaceutical companies in the US, EU and Asia on GLP compliance in laboratory operations and in the quality control of regulatory submissions.
Bergen Community College Quality Assurance Program
Pitkin Education Center - Room S-321
Phone (201) 493-7521 E-Mail: jfitzpatrick@bergen.edu |