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Jonathan Green, PhD, has been involved in the pharmaceutical industry for more than 20 years. He has managed groups responsible for analytical and bioanalytical methods development and validation, set up quality systems by writing and training standard operating procedures, assembled regulatory submission packages, and built infrastructure in the various labs he has directed. Research projects he has led include methods development, validation, and transfer for small- and large-molecule bulk drugs; determining steroid concentration in canine plasma by liquid chromatography/mass spectrometry/mass spectrometry; analysis of coal-tar derivatives by high-performance liquid chromatography; immunoassays (Insulin RIA, Calcitonin DELFIA); stability-indicating methods in several finished dosage forms (tablets, capsules, parenterals, oral solutions, and lyophiles); abuse liability studies of scheduled compounds; in vitro skin permeation studies of scheduled compounds using dissolution apparatus with enhancer cells; identification of unknown metabolites in plasma, urine, and feces; and analysis of surgical instruments for trace amounts of hydraulic fluid. | 