Pharmaceutical Chemist Consultant for Drug Analysis, Validation and Quality Control (1231)
Expertise
Lead major drug firm's team in pharmacokinetics and drug metabolism.
Analytical CMC requirements for pharmaceutical testing and stability (IND, NDA, WMA, ICH and EMEA Guidances).
Pharmaceutical analysis for quality and led transfer of analytical research methods to commercial production.
Pharmacopeia analytical technical leadership.
Analytical methods development, documentation, transfer, troubleshooting and support and analytical support for formulation design and process validation.
Analysis and validation of over the counter (OTC) pharmaceuticals.
Safety, clinical and commercial product release.
Pharmaceutical specifications for quality assurance and FDA compliance in drug production.
Analytical pharmacopeial issues.
Excipient formulations, qualifications and controlled release.
Experience
Consultant:
Pharmaceutical industry in analytical research methods development, validation and documentation for drug substances and finished pharmaceutical products.
Guidance in all analytical aspects of regulatory and compendia compliance and in the preparation for filings, inspections and responses to regulatory citations.
Merck
Senior Director, Regulatory and Analytical Sciences, Merck Manufacturing Division Merck & Company: Responsible for transfers of all analytical methodology from PR&D to the worldwide Quality Operations laboratories at the pharmaceutical manufacturing sites and for analytical site trouble-shooting support of both bulk and pharmaceutical products. Management of analytical pharmacopeia issues within Merck.
Senior Director, Pharmaceutical Analysis and Control, Pharmaceutical Research & Development, Merck Research Laboratories: Design and validation of analytical methods and their application for formulation design, stability evaluation and clinical release of human dosage forms and Safety Assessment dosing vehicles. Responsible for expansion of instrumental, robotics and computer expertise within these units. PR&D activities with the Johnson & Johnson joint venture and participated with DuPont joint venture in co-development projects OTC products.
Director, Pharmaceutical Analysis and Control, Pharmaceutical Research & Development, Merck Research Laboratories: Preparation and review of critical chemical and manufacturing documentation for FDA submission and responses.
Senior Research Fellow, Pharmaceutical Analysis and Control Pharmaceutical Research & Development, Merck Research Laboratories: Design and validation of analytical methods for the stability indication of drugs in dosage forms and in Safety Assessment dosing vehicles. Expansion of instrumental technical expertise in quantitative analysis for the department.
Hoffmann-LaRoche
Senior Research Group Chief, Department of Pharmacokinetics, Biopharmaceutics, and Drug Metabolism Hoffmann-LaRoche: Design and implementation of analytical methods for the analysis of drugs in biological fluids using high performance liquid chromatography and gas-liquid chromatography with mass spectrometric quantitation. Managed the departmental quality assurance program for the analysis of drugs in biological fluids for analytical preclinical and clinical pharmacokinetic studies conducted within the corporation and in outside contract laboratories.
Honors & Publications
Sixty-eight publications
Fellow, American Association of Pharmaceutical Sciences
Editorial Advisory Board, Journal of Pharmaceutical and Biomedical Analys
Education
Ph.D., Analytical Chemistry, University of Maryland
B.S., Science, Lafayette College