Microsoft Word - LowLactose_ERP-Proposal-May2019

honey. among others. These research efforts encompassed the diverse types of FDA regulated human and animal food products, both domestic and imported, including infant formulas, nutritional/dietary supplements, other human foods, pet foods and animal feeds and other foods. o Data monitoring for quality assurance (data of numerous different combinations of analytes and SRMs) and the generation of Control Charts per each quarter, calculation of in-house values and method uncertainties, communication with ORS scientists and compliance officers in the fields. o A member of Chemistry SME in LIMS change management process (CMP) at SFFL. o Served as a lecturer in DHRD/OTED sponsored trainings including LB246 (Private Lab Package Review, PRL-SW, Irvine, CA, Sep 2014) and LB 305 (Advanced Chromatography, SRL, Atlanta, GA, Aug 2013) and other introductory training courses for CSOs held in SRL/SFFL. 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 Serve as a panel member and the chair for the grants review by OAGS ORB (e.g., VNRFRPS and ISO/WGS for State Food Testing Labs). o Serve as a panel member and the chair for the Racial and Ethnic Approaches to Community Health (REACH) Grant review and Cancer Prevention and Control Programs for State, Territorial, and Tribal Organizations Grant Review by the Division of Cancer Prevention and Control (DCPC), Centers for Disease Control and Prevention (CDC). o Analyze regulatory samples in all aspects of NAB’s programs, particularly more challenging sample analysis when the technical difficulties are encountered. o Label reviews of Nutrition facts labels and Supplement facts labels of regulatory samples. o Answered numerous technical inquiries from ORA or CFSAN scientists on NAB’s behalf by writing memos and communicated with compliance officers, other FDA personnel, or other representatives from industry. o Wrote multiple acquisition packages for the analytical instruments and peripherals to expand the capabilities of NAB (including UHPLC-MS/MS, dietary fiber analyzer, UPLCs, evaporators, protein analyzer, gas generators 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).

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