Specialties:
Services:
Ph. D. synthetic organic chemist with 20 years experience in the
discovery and development of active pharmaceutical ingredients (APIs).
Expert in the design, execution, and process scale-up of complex synthetic
routes to NCEs, especially chiral molecules and chirality problems.
Medicinal Chemistry experience in the SAR of nucleosides and peptide mimics.
Excellent command of process development chemistry and ability to solve
interdivisional problems in analytical, synthesis, manufacturing, as applied
to Phase 1 through manufacturing.
Excellent command of regulatory requirements for cGMPs (SOPs) as applied to Phase 1 through commercial and
writing CMC modules in CTD format.
Experience in the tech transfer and process validation for the manufacture of drug substance.
Excellent at rapidly solving both process and analytical-related issues through the
design and execution of the necessary experiments.
Up to date at patent and literature searching using Cross Fire and SciFinder.
Excellent understanding of the contract research and development industry gained
through 20 years experience working in the business.
LET US MANAGE YOUR DRUG SUBSTANCE PROGRAM FROM MILLIGRAM TO KILOGRAM.
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