Pharmaceutical Experience
Worked with external customers of FMC's
Lithium Division -- a major supplier of lithium carbonate (Li2CO3) for treatment
of bipolar disorders. Also, various lithium organometallic compounds are used
as active intermediates in the production of modern pharmaceuticals. Responsibilities
included working with our external customers to assure consistent chemical composition
and particle size distribution.
Served as Analytical Coordinator for $3 million research project that pioneered
the introduction of a novel pharmaceutical product for osteoporosis prevention
and treatment.
-- Coordinated analytical components of NDA submission, Phase I & Phase
II clinical trials.
-- Studied dose/response trends of various formulations.
-- All work was done under GMP/GLP regulations.
Provided analytical support to guide development efforts for a new cost-effective
route to commercial production of ibuprofen. Ethyl Corporation (later renamed
Albemarle Corporation)
now operates the largest North American ibuprofen production facility in Orangeburg,
SC based on this technology.
Worked on several drug-intermediate projects:
-- Zomepirac – analgesic for McNeill Labs
-- Tolrestat – drug for diabetes, clinical trial samples
-- Ketoprofen – next generation after ibuprofen, now OTC as Orudis KT
-- Tolmetin – anti-inflammatory
-- Cimetidine – active ingredient in OTC formulations of Tagamet
Worked closely with Ethyl Corp.'s pharmaceutical subsidiary (Nelson Research)
and their spin-off company (Whitby Pharmaceuticals) to develop and validate
analytical methods in support of their drug studies.
Analytical experience in developing quantitative methods to assess the purity
and identity of drug substances and starting materials, determining the identity
of unknown manufacturing impurities and degradation products and transferring
these methods to other scientists inside and outside of Ethyl Corporation.
Experienced in the following Procedures and Protocols: FDA, GLP, GMP, NDA,
& USP.
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