Expertise DescriptionI have more than 35 years experience in the field of cGMP pharmaceuticals with expertise in dietary supplement supplier auditing, chemical/pharmaceutical process improvement, and cost reduction through on-line analysis and analytical problem solving. I have experience in research services and quality assurance departments. I have significant expertise in the areas of analytical and polymer chemistry, quality systems and regulatory affairs, with a strong reputation for excellence in analytical problem solving and materials characterization, quality improvement programs and building and motivating technical staffs to be highly productive. I have developed IP, constructed new laboratories and coordinated global organizations. I have consulted in the areas of analytical in process / laboratory problem resolution and cGMP auditing / compliance gap analysis of pharmaceutical and dietary supplement suppliers, cost reduction respectively. I have over 5 years expert witness experience.
Areas of Expertise
My consulting experience includes opportunities to increase yield and reduce cost at a major inorganic chemicals company through the use of an on-line Raman spectroscopy;
My professional experience includes President of an independent consulting business serving the chemical and pharmaceutical industries, with prior experience as Vice President of Analytical, Regulatory and Technical Information Services, Vice President of Analytical, QA and Product Stewardship, Senior Director of Analytical, QA, and Technical Information Services, Director of Analytical Department, Manager, Group Leader, and Senior Research Chemist.
|Ph.D.||Physical Chemistry||New York University|
|M.S.||Physical Chemistry||New York University|
|B.S.||Chemistry||City College of New York|
|Certified Quality Auditor (CQA) credential|
Awards & Affiliation
|American Chemical Society: Analytical and Polymer Divisions member|
|International Society for Pharmaceutical Engineering (ISPE)|
|American Association for Pharmaceutical Scientists (AAPS)|
|American Society for Quality (ASQ)|
American Chemical Society
Partial List of Consulting Expert Witness Cases