Provided scientific, regulatory, and project management support for the development of new pharmaceuticals, biologics, and medical devices. Comprehensive support provided for the design and management of chemistry, manufacturing, and controls (CMC) operations for drug substance and drug product over the life-cycle of product development. Prepared the full range of CMC submissions for INDs, NDAs, BLAs, DMFs, and PMAs for submission to FDA. Design and manage contract manufacturing operations through broad network of contract research organizations.

Served as primary reviewing chemist for chemistry and manufacturing control sections of Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Drug Master Files (DMFs). Had primary regulatory responsibility for the review and approval of both drugs and biotech products (was one of four chemistry reviewers responsible for the review of biologics regulated by CDER). Specifically, primary review assignments included antihypercholestremics, antihyperglycemics (animal as well as biotech-derived insulins and their analogues), biotech-derived growth hormones, and other biotech-derived hormones and analogues. Responsible for the overall assessment of drug substance characterization studies, as well as drug substance and drug product manufacturing control strategies, release specifications, stability-testing protocols, reference standard qualifications, container/closure system qualifications, labeling, and environmental assessments. Also performed basic research at the National Institutes of Health under the Agency’s Professional Development program.

Conducted postgraduate research in glycobiology, biochemistry, chemistry, and molecular biology under Dr. Gilbert Ashwell in the Laboratory of Biochemistry and Metabolism.

Conducted postgraduate research in synthetic organic chemistry and glycobiology under Dr. T.Y. Shen.

Graduate study and research leading to a Ph.D. in organic chemistry, specializing in the chemistry of the carbohydrates. Recipient of the 1987 National Corn Sugar Refiners Scholarship for dissertation-year research in carbohydrate chemistry.