
Min-Hyung Lee
Laboratory Assistant

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About me
Pharmaceutical Scientist (Product Quality CMC Reviewer) at FDA
Education

Yonsei University
1996 - 2001BS BiotechnologyB.S. in Biotechnology

Case Western Reserve University
2005 - 2010Ph. D. BiochemistryPh.D. in Biochemistry

Kansas State University
2004 - 2005Mollecular, Cellular, Developmental BiologyGraduate Student (transferred to Case Western Reserve University in 2005)
Experience

Yonsei University
Sept 1999 - Feb 2001Laboratory Assistant
Myung In Pharm. Co. Ltd.
Aug 2001 - Jun 2003Research Fellow / Laboratory Manager- Participated in the drug formulation research and controlled the dissolving patterns of drugs such as extended-release drugs and immediate-release drugs by analyzing the drug ingredients by HPLC- Maintained technical files (SOPs, specifications); managed laboratory equipment

Green Biotech Co. Ltd.
Jul 2003 - Jul 2004Research Fellow / Assistant Manager- Enhanced the quality and the concentration of the crude saponin and ginsenoside in redginsengwith UHP (ultra-high pressure) protocol- Formulated functional food gradients to optimize and to balance nutritional value and cost- Controlled antimicrobial activities of fungus pigments (Monascus sp.) derived with aminoacids to improve preservative characteristics of food- Managed the stock of company products; ordered laboratory reagents; implemented laboratory procedures

Kansas State University
Sept 2004 - May 2005Graduate Teaching Assistant- Investigated regulation of apoptosis by Op-IAP (Baculovirus Orgyia pseudotsugata inhibitor of apoptosis) genes in Drosophila cells
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Case Western Reserve University (Cleveland Clinic Foundation), Roswell Park Cancer Institute
Sept 2005 - Jan 2011Ph.D. Student (Pre-Doc) / Research Affiliate (Pre-Doc)- Investigated the role of histone methyltransferase SUV39H (KMT1A) in silencing differentiation program in human alveolar rhabdomyosarcoma (ARMS) cells- Generated cell-based readout system and screened the small molecule library in order to target the restoration of abortive myogenic differentiation program in ARMS cancer cells- Characterized and validated primary ‘hits’ in restoring ARMS cell differentiation to utilize them in the targeted therapy for the treatment of ARMS - Investigated the differentiation-promoting function of screened chemical compounds in ARMS to utilize them in the targeted therapy for the treatment of ARMS Show less
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National Cancer Institute, National Institutes of Health (moved from FNLCR, NCI, NIH)
Mar 2011 - Nov 2015CRTA Postdoctoral FellowMy study focused on astrocytoma, one of the most common primary brain tumors and utilized genetically engineered mouse (GEM) model harboring Nf1 and p53cis mutation, which develops neurofibromatosis, fundamentally astrocytoma/GBM. Using this GEM model;- Identified a novel oncogenic modifier gene that drives gliomas only in males, which has crucial implications for the application of personalized therapies to human GBM, male-predominant disease- Clarified the mechanism of this novel sex-specific oncogene in the context of Nf1-mutant astrocytoma/GBM in human and mouse for the development of personalized therapeutic approaches Show less

FDA
Jan 2016 - now연구/심사
Research Scientist (CURES - CMC Reviewer)
Oct 2022 - nowResearch Reviewer (CMC Reviewer)
Jun 2019 - nowResearcher (ORAU)
Jan 2016 - Jun 2019
Licenses & Certifications

Basic Rodent Survival Surgery Training
National Institutes of HealthSept 2015.webp)
Federal Acqusition Certificate for Contracting Officer Representative
Federal Acquisition Institute (FAI)Mar 2022
Writing and Publishing a Scientific Paper
U.S. Department of Health and Human ServicesApr 2015
Principles of Clinical Pharmacology
National Institutes of HealthApr 2013- View certificate

Group 2: Animal Handlers (Fellows, Students, Researchers)
CITI ProgramMay 2022
Honors & Awards
- Awarded to Min-Hyung LeeInvited Speaker, Virginia Washington Metro Regional Conference (VWMRC), Vienna, VA, 2015 KSEA Apr 2015
- Awarded to Min-Hyung LeeRecipient of “Outstanding Poster Presentation Award”, Inaugural Symposium on U.S. NIH-Korea Collaborative Biomedical Research, NIH, Bethesda, MD, 2015 NIH Apr 2015
- Awarded to Min-Hyung LeeInvited Speaker, Pediatric Oncology Branch Research Seminar Series, Bethesda, MD, 2014 NIH Dec 2014
- Awarded to Min-Hyung LeeRecipient of “Best Poster Presentation Award”, The 6th Annual Bioscience and Engineering Symposium, NIH, Rockville, MD, 2014 KSA Dec 2014
- Awarded to Min-Hyung LeeSelected as a Platform Presentation Speaker, The 19th Annual Scientific Meeting & Education Day of the Society for Neuro-Oncology, Miami, FL, 2014 SNO Nov 2014
- Awarded to Min-Hyung LeeSelected as an Invited FARE Winner Speaker at the Research Symposium, Rare Tumor Research at NIH Session, The NIH Research Festival, NIH, Bethesda, MD, 2014 NIH Sep 2014
- Awarded to Min-Hyung LeeInvited Speaker, Neuron-Glia Interactions Scientific Interest Group Meeting, Bethesda, MD, 2014 - May 2014
- Awarded to Min-Hyung LeeSelected as an Oral Presentation Speaker, The 14th Annual CCR Fellows and Young Investigators Colloquium, NCI, Frederick, MD, 2014 NIH Mar 2014
- Awarded to Min-Hyung LeeRecipient of the Fellows Award for Research Excellence (FARE) 2015 competition, Bethesda, MD, 2014 NIH 2014
- Awarded to Min-Hyung LeeSelected as an Oral Presentation Speaker, The 13th Annual CCR Fellows and Young Investigators Colloquium, NCI, Frederick, MD, 2013 NIH Mar 2013
- Awarded to Min-Hyung LeeSelected as a Platform Presentation Speaker, The 17th Annual Scientific Meeting & Education Day of the Society for Neuro-Oncology, Washington, DC, 2012 SNO Nov 2012
- Awarded to Min-Hyung LeeRecipient of Scholarship, The 26th International Mammalian Genome Conference, Tradewinds, Resort, St. Pete Beach, FL, 2012 IMGC Oct 2012
- Awarded to Min-Hyung LeeRecipient of “Outstanding Poster Presentation Award”, The 26th International Mammalian Genome Conference, Tradewinds Resort, St. Pete Beach, FL, 2012 IMGC Oct 2012
- Awarded to Min-Hyung LeeSelected as a Platform Presentation Speaker, The 26th International Mammalian Genome Conference, Tradewinds Resort, St. Pete Beach, FL, 2012 IMGC Oct 2012
- Awarded to Min-Hyung LeeAwarded High Honor Student by Dean of Yonsei University, Yonsei University, Seoul, Korea, 2000 Yonsei University 2010
- Awarded to Min-Hyung LeeRecipient of University Scholarship, Yonsei University, Seoul, Korea, 2000 - 2010
Volunteer Experience
Lead of OPQ Tumor Biology COE Seminar Committee/Initiative
Issued by FDA OPQ Tumor Biology Center of Excellence on Jul 2018
Associated with Min-Hyung LeeSocial Committee
Issued by KoFDA (Korean FDAers' Association) on Jan 2017
Associated with Min-Hyung LeeCommittee Member (Scientific Affairs)
Issued by National Institutes of Health - Korean Scientists Association on Jan 2014
Associated with Min-Hyung LeeParticipated in planning and developing symposium agenda
Issued by Organizing Committee Member of Inaugural Symposium on US NIH-Korea Collaborative Biomedical Research on Jan 2015
Associated with Min-Hyung Lee
Languages
- koKorean
- enEnglish
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