SPSFAM_Sugar_ERP-92018Proposal

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o Co-chair of Food Additives/Nutrients/Dietary Supplements Methods Technical Advisory Group (TAG) of Chemistry Research Coordination Group (CRCG) of OFVM. o Chemistry Expert/Technical Lead (Nutrition Program) in private lab analytical package review. Wrote the guidelines and provided expert reviews for the PLAPs (especially pertinent to IA 99-39, 36-01, and 45-06, among others) o A member of Chemistry SME in LIMS change management process (CMP) at SFFL. o Served as a lecturer in DHRD sponsored training (LB 305 Advanced Chromatography and other introductory training courses for CSOs held in Atlanta) o Trained NAB personnel for regulatory sample analysis and instrumentations (e.g., analysis of water soluble vitamins and fat soluble vitamins via LC-MS/MS methods) o Served as a panel member and chair for ORB Grant (by OAGS) review board, e.g., VNRFRPS and ISO/WGS for State Food Testing Labs. o Served as a panel member for a CDC Grant review board of CPCP for State, Territorial and Tribal Organizations. o Analyze regulatory samples, particularly more challenging sample analysis when the technical difficulties are encountered. o Answered technical inquiries from ORS and CFSAN scientists (via the NAB Director) by writing memos (as a summary) and communicated with compliance officers and other FDA personnel. o In-house data monitoring for quality assurance (data from ca. 60 combinations of different analytes in SRMs) and the generation of Control charts per each quarter. o Wrote multiple acquisition packages for the instruments to expand the capabilities of NAB, which led to the successful acquisitions of high-end analytical instruments (including three UHPLC-MS/MS, Dietary Fiber analyzer, UPLCs, evaporators, protein analyzer, and others).  Oct. 2010 – Oct. 2011: FDA Commissioner’s Fellow (Class of 2010), ACNA/SRL/ORA/U.S. FDA, Atlanta, GA. o Developed and validated a LC-MS/MS method for the analysis of vitamin K in infant formulas, dietary supplements and other nutritional formulas. o To gain more regulatory experience, I joined FDA through a highly competitive FDA Commissioner’s Fellowship Program (CFP). The objective of CFP was to provide an opportunity for scientists to get trainings and experience in FDA regulatory sciences across the fields of devices, drugs, biologics, foods, tobacco, and cosmetics. In addition to my own research project, I have received graduate level trainings in FDA law and policy, federal budget process, networking and leadership skills, communications with the public and press, biostatistics, epidemiology, clinical trial design, risk assessment and risk management, and case-based learning classes.  2007 - Sep. 2010: Post-doctoral Fellow , Pacific Northwest National Laboratory, Biological Monitoring and Modeling Group, Richland, WA (Advisor: Charles Timchalk, Ph.D., DABT). o Investigated impacts of mixture interactions (including, smoking, alcohol consumption and dietary intake) on pharmacokinetics and pharmacodynamics (PK/PD) of organophosphorus (OP) pesticides via in vitro and in vivo studies, in combination with in silico PBPK/PD modeling. o Run multiple in vivo studies (Sprague-Dawley rats, minimigs, rabbits and others) for the PK studies. Analyzed pesticides (and metabolites), nicotine and related compounds and its metabolites in diverse animal tissues by GC-MS method. o Published studies in multiple journal articles and presented in national and international meetings. o Served as a study monitor for preclinical (Phase I GLP) toxicity studies of radioactive isotopes ( 241 Am and others) using animals (rats and rabbits). o Studied the oxidative stress biomarkers (nitrotyrosine) and pesticide metabolisms in brain after the pesticide exposures using neonatal animals via MRI/MRS. o Studied quantum-dot nanoparticles’ effects on lymphatic systems in vivo under Environmental biomarker Initiative (EBI).  2000 - 2007: Research/Teaching Assistant , Interdisciplinary Toxicology Program, University of Georgia, Athens, GA (Advisor: Prof. James V. Bruckner).

Sookwang Lee, Ph.D., D.A.B.T.