Expert Scientist
Resume:
Gus Sang-woon Myung
Cary, NC 27519
919-***-**** (C)
E-mail: acy7kc@r.postjobfree.com
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OBJECTIVE: To obtain a long-term career opportunity with an organization in the area of biotech and pharmaceutical research and development that utilizes my professional experiences and educational backgrounds.
EXPERIENCE: GlaxoSmithKline Vaccine (Novartis) Research Triangle Park, NC
Expert Scientist, Analytical Development (2012-2017)
Responsible within the drug development team for development, qualification, and tech transfer of analytical assays in support of release, characterization and stability testing of vaccine candidates for clinical trials.
Development of an ELISA based host cell protein (HCP) immunoassay for HIV, RSV pre-F and RSV-F vaccines upstream, downstream and drug substance samples
Development of the In vitro potency assays using a surface plasmon resonance (SPR) based Biacore for HIV, RSV pre-F and RSV-F vaccines in-process, drug substance, drug product, stability and release samples.
Development of Slot Blot assay for identification of HIV, RSV pre-F and RSV-F vaccine products
Threshold DNA Detection Assay for determination of total DNA content in Flu Cell Culture in-process and drug substance samples
Analytical testing of various vaccine candidate samples in support of stability, formulation, CTM, in-process, drug substance, drug product and GMP testing
Experience working in Biosafety Level 2 (BSL-2) labs
Revised, reviewed and authored test method SOPs and technical reports
Responsible for providing technical training/mentoring of laboratory staff
All works performed in cGMP/GLP regulation and compliance
Proven record of strong technical skills and scientific expertise in assay development and troubleshooting.
Proven record of delivering results in a fast-paced environment and effective communication to project teams and external partners
Covance Greenfield, IN
Staff Scientist, Biotechnology Service Department (2011-2012)
Responsible for providing technical expertise and hands on support as a “floater” in the Bioassays, Immunochemistry and Protein Chemistry groups
Responsible for providing technical training/mentoring of junior laboratory staff
Participates in Laboratory investigations
Writes SOPs supporting analytical testing, Quality systems, data systems, technical issues and instrumentation
ELISA assay for Mouse Immunogenicity of Human Papillomavirus (HPV) Virus-like Particle (VLP) Vaccine
ELISA assay for detection of residual ARPE-19 Host Cell Protein
All works performed in cGMP/GLP regulation and compliance
ABC Laboratories Columbia, MO
Staff Scientist, Biotech Development (2011)
Responsible for planning and supervising daily activities in CRO’s laboratory
Responsible for development and validation of immunoassays for cGLP and cGMP studies as requested by clients
Development of competitive ELISA method for quantification of cyclic Guanosine Monophosphate directly from human plasma
Responsible for cell-based potency assay for Filgrastim drug substance
Responsible for generating protocols, standard operating procedures and method reports according to regulatory guidelines
Responsible for the quality and accuracy of the data and reports sent to client
Pfizer (Wyeth) Research Triangle Park, NC
Sr. Research Scientist, Analytical Development in Vaccine Development (2004-2010)
Responsible for development, qualification, validation and transfer of analytical methods in support of release, characterization and stability testing of vaccine candidates for clinical trials
Analytical and Bio-analytical assays include cell-based bioassays, immunoassays (ELISA, Slot Blot, Western Blot and Nephelometry), HPLC, CE and platforms technology based assays (e.g., ECL-BioVeris, Luminex-Bioplex multiplex and Biacore) and Hamilton microplate-based robotic instrumentation
Development of an ELISA based immunoassay for the identification of an immunotherapeutic peptide conjugate
Development of an ELISA method for quantification of individual sub-serotype in a multi-valent glycoconjugate vaccine product
Qualification of Slot Blot assay for identification of each individual serotype of conjugates in multi-valent vaccine product
Development of a cell culture based cytotoxicity assay to determine the toxicity level of carrier protein used in glycoconjugate and peptide conjugate vaccine products
Development, qualification and validation of monoclonal antibody based relative In vitro potency assays for vaccine drug substance and drug product candidates using platform technology: BioVeris, Luminex-BioPlex and Biacore
Development of an immunoassay to determine Staphylococcal enterotoxin level in α-capsular polysaccharide samples
Qualification of critical reagents including monoclonal and polyclonal antibodies used for development and characterization assays
Affinity purification of antibodies from ascites and tissue culture supernatants using AKTA and labeling of purified antibodies for use in potency assay
Analytical testing of samples in support of stability, formulation, CTM, toxicology, demo, in-process and GMP testing
Revised, reviewed and authored test method SOPs and technical reports
Data management through LIMS systems
All works performed in cGMP/GLP regulation and compliance
Diosynth RTP Inc. (Akzo Nobel) Research Triangle Park, NC
Senior Quality Control Associate (2002-2004)
Responsible for the performance of various assays including Reverse Phase, Size Exclusion, Ion Exchange and Peptide Mapping HPLC, Capillary Electrophoresis, PCR, HCP (Host-Cell-Protein)-ELISA, enzymatic activity and UV/VIS for In-Process, Final Bulk and Stability products
Responsible for conducting routine and non-routine analysis of raw materials in process and finished product according to SOP/STM
Responsible for GMP release and stability testing of clinical samples
Responsible for training analysts to routinely perform assays under cGMP conditions, review results and archive electronic data
All works performed in a GMP controlled laboratory environment
Nobex Corporation (Formerly Protein Delivery Inc.) Research Triangle Park, NC
Research Associate II, Department of Analytical Chemistry (1998-2002)
Responsible for development, optimization, validation and application of analytical methods for the characterization of biotherapeutic drug candidates (e.g., conjugated oral insulin and calcitonin) using HPLC, UV, Fluorescence, SPE, LC-MS and immunoassays
Selection, optimization and validation of Immunoassays (Delfia, ECL, BMI ELISA) and Radio-immunoassays (Pharmacia RIA, Peninsula RIA, Linco RIA, DSL RIA) to quantify biological activity of conjugated protein compounds for oral delivery
Enzymatic degradation assays for proteins and protein conjugates
Structural characterizations of proteins and protein conjugates by proteolytic digestion and HPLC Peptide Mapping to identify the site of modification
Protein recovery test from dosed animal: Extraction of conjugated proteins from plasma by Solid Phase Extraction and analysis by HPLC and immunoassays
HPLC maintenance, troubleshooting, repair and backup of electronically generated HPLC data
Writing of SOPs and keeping detailed records of experiments and results
North Carolina State University, Raleigh, NC
Graduate Research and Teaching Assistant, Protein Chemistry Laboratory in Department of Food Science (1995-1997)
Design of an Avidin-Biotin affinity column chromatography for protein and development of a bioreactor using immobilization technology
Immobilization of -galactosidase on ceramic membrane module to characterize a bioreactor for production of lactose-free milk, cheese and other dairy products
Immobilization of glycomacropeptide to prevent fouling of milk adsorption on ultrafiltration membrane module
Teaching Assistant to a Graduate Course, Protein and Enzyme
Duke University/Durham VA Medical Center, Durham, NC
Research Technician III, Aging Center (1993-1995)
Development and testing of Interleukin-6 (IL-6) and Cross-Linked Fibrin Degradation Products (XDP) ELISA assay with human plasma matrix
Isolation of epithelial cells from human umbilical cords
Electrophoresis, cell cultures, various biochemical and immunological assays.
Fluorescence activated cell sorting and analysis in conjunction with the study for Alzheimer’s disease and aging process
EDUCATION: North Carolina State University, Raleigh, North Carolina
Master in Food Science (Protein Chemistry) (1997)
North Carolina State University, Raleigh, North Carolina
Bachelor in Biochemistry (1990)
COMPUTER
SKILL: Laboratory Information Management Systems (LIMS), Waters Millennium 32, Agilent Chemstation, Sigma Plot, SoftMax Pro, and Microsoft Office
TRAINING
COURSES: Level 2 Millennium 32 Software (both Basic and PDA) by Waters
HPLC Trouble Shooting & Repair by Agilent
Solid Phase Extraction workshop by Jones Chromatography
Biacore Training by GE
REFERENCES: Available Upon Request
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