Associates -- www.malawerconsulting.com

Malawer & Associates Consulting, LLC

Pharmaceutical, Chemical, & Cleantech Value Creation

Associates

Malawer & Associates Consulting, LLC maintains a flexible workforce of associates who assist the firm as needed based upon project manpower requirements and consistent with their individual skills and specialties. All of the firm’s associates are very senior and highly experienced experts in their respective fields and industries.

Dr. Irwin B. Silverstein— quality systems, cGMP auditing, excipients

Dr. Silverstein is an expert in the area of quality systems for excipient manufacturing. Irwin is President of IBS Consulting in Quality, LLC. He is also the Vice President and Chief Operating Officer of International Pharmaceutical Excipients Auditing, Inc. (IPEA). Prior to these current roles, Dr. Silverstein managed the corporate quality assurance function at International Specialty Products (ISP) for 17 years. Irwin is also a consultant to the International Pharmaceutical Excipients Council participating in the development of international standards for excipient GMP and Good Distribution Practices (GDP). He also volunteers with the American Society for Quality where he has written many questions for use in the Pharmaceutical GMP Professional certification exam. Dr. Silverstein obtained his Ph.D. in organic chemistry from New York University and possesses a CQA credential from the American Society for Quality (ASQ).

Dr. Steven Ostrove—cGMP validation, regulatory documentation

Dr. Ostrove has been involved in the Bio-Pharmaceutical business for over 35 years. He has worked as a Senior Technical Specialist in the Technical Service Department of Pharmacia Biotechnology and as the Senior Director of Validation and Regulatory Affairs with major design/build engineering companies. He opened Ostrove Associates, Inc. (OAI), 1999. Steve has been an invited course leader, lecturer and guest speaker for both national and international conferences. He has served as an adjunct professor of Pharmaceutical Engineering at the New Jersey Institute of Technology for Validation and Regulatory Affairs and at Kean College in Biology. He recently completed service as the industry representative on an FDA advisory panel and as the Acting Manager of Validation for a contract pharmaceutical and OTC manufacturer. Dr. Ostrove holds a B.S. degree from the State University of New York at Albany in Biology / Chemistry, an M.S. degree in Biology (cell culture) from Adelphi University and a Ph.D. degree in Biochemistry from Rutgers University.

Joel Schwartzman — quality systems, cGMP auditing, GLP auditing, ISO auditing

Joel Schwartzman is a CQE and CQA with extensive experience in GMP, GLP and ISO 9000. Mr. Schwartzman is known for his ability to manage quality improvement projects using quality engineering techniques to develop systems and procedures which increase productivity and reduce costs while providing improved control of procedures and products. He has worked at Enzon Pharmaceuticals as a quality specialist, at Bellcore as a quality engineer and technical manager, at KMPG as an ISO auditor, at Airwick Industries as the Director of Corporate Quality Assurance to implement the new function and at Warner-Lambert as a quality engineer in consumer and eye care products. He had prior experience at the FDA as a field investigator and chemist. Joel has taught related topics for the CQE, CQA, CQT and ISO refresher courses for the North Jersey ASQ section. He also helps colleges maintain their college accreditations as a reviewer for the Higher Learning Commission of the North Central Accreditation. Mr. Schwartzman received a B.S. degree in chemistry from Long Island University and an MBA from Fairleigh Dickinson University.

Dr. Ronald J. Sternfels—process optimization, design of experiments, statistical analysis

Dr. Sternfels is an expert in the area of statistical analysis and design of experiments as applied to the optimization of industrial processes. Dr. Sternfels has applied his skills in the chemical, defense electronics, health care, telecommunications, and manufacturing industries. Ron is currently an Assistant Professor at Roane State Community College in Knoxville, TN. Over the course of his career, he has worked at Technicon Instruments Corporation, United Technologies, Oak Ridge Associated Universities, and the QualPro Consulting Group where he was involved with process improvements efforts at companies such as DuPont, BASF, Dyno Nobel, International Specialty Products (ISP), S.E. Johnson, Southwestern Bell, and Bealieau of America. Dr. Sternfels received a B.S. in chemistry from the City College of New York, an M.S. from the University of Rochester, and a Ph.D. from New York University in mechanistic organic photochemistry / photophysics. He also earned an executive MBA from the University of New Haven.

Ian Edwards - quality systems, cGMP auditing, ISO auditing, excipients

Mr. Edwards is founder of the consulting firm, Havard Quality Solutions Ltd in the UK. He possesses over 20 years of prior experience in the quality assurance and control organizations of firms such as International Specialty Products (ISP) and Arista Laboratories. Ian has a broad quality management systems background in both the pharmaceutical (cGMP) and non-pharmaceutical areas (ISO 9001 (lead auditor), ISO 17025, and ISO 14065/VCS). Mr. Edwards has additional experience in analytical method development for Duracell and Rank Hovis. Ian obtained a M.Sc. in analytical chemistry from the University of London and has earned the Certified Quality Auditor (CQA) credential from the American Society for Quality (ASQ). Mr. Edwards was recently accepted by IRCA (International Register of Certified Auditors) at a Provisional Auditor grade.

Dr. Bill Sullivan– inorganic pigments, IP development, R&D project management

Dr. Sullivan is President of Plan B Research Services, LLC. He is presently consulting for firms in the areas of optimizing research and development activities, performing due diligence assessments for alliances and acquisitions, managing R&D projects and solving technical problems with fine particles and pigments. Bill has more than 35 years experience leading R&D organizations and most recently was the Technical Director for Engelhard’s Effect Materials business. He has participated in numerous alliances and acquisitions, is a recognized expert on pearlescent pigments and has been associated with the commercialization of more than 600 new products in his career. Dr. Sullivan has a Ph.D. in physical and analytical chemistry from Seton Hall University.