Quality Assurance Manufacturing

Ching-Hsin Wu

st

***-** ** **., *** **D, Flushing, NY, 11355

618-***-****, *************@*****.***

EDUCATION

St. John’s University Queens, New York

Master of Science in Pharmacy Administration - Regulatory Affairs and January 2014

Quality Assurance

Cumulative GPA 3.81/4.0

National Cheng Kung University Tainan, Taiwan

Master of Science in Chemical Engineering June 2007

National Chung Hsing University Taichung, Taiwan

Bachelor of Science in Chemical Engineering June 2004

RELATED COURSEWORK / PROJECTS

Good Manufacturing Practices

Composed a Response Letter to actual FDA Warning Letter individually including specific opinion of

observed problems in the WL and possible solutions

Regulatory Submissions & Drug Approval Process (IND/NDA, CTD/eCTD)

Worked with a team to create CTD of drug product Lisdexamfetamine Dimesylate for NDA submission

Advanced Food & Drug Law Regulation, International Drug Regulatory Affairs, Basic Concepts of Drug

Development

SKILLS

Laboratory Analysis

1 13

Optical spectroscopy: UV/VIS, FT-IR, H/ C NMR Chromatography: HPLC, GC, GPC

Electron microscope: SEM, TEM Thermodynamic analysis: DSC, TGA

Others: XRD, Electrochemistry, DLS, Capillary Rheometer, Spectroscopic Ellipsometer, OM

Computer

Microsoft Word, Excel, and PowerPoint, Fortran 95, ChemDraw, MathCad, OriginLab

PROFESSIONAL EXPERIENCE

Industrial Technology Research Institute of Taiwan Tainan, Taiwan,

Associate Researcher October 2007 – July 2010

Customized TiO2 nanoparticles for industrial applications of solar cell, interfacial materials, etc.

Scale-up industrial production and verified manufacturing SOPs

Searched and reorganized latest relevant reference

National Science Council of Taiwan Tainan, Taiwan,

Research Assistant September 2005 – June 2007

Synthesized Carbon Nanotube modified Cation Exchange Membrane for fuel cell

Searched and reorganized academic data relative to fuel cell

Data Processing and Analysis

Assisted in operating and integrating fuel cell application

ADDITIONAL WORKING EXPERIENCE

National Cheng Kung University Tainan, Taiwan,

Tutor September 2005 – June 2007

Guided international students to Chinese learning and revised students’ assignments

PUBLICATION

2013

Patent : Multilayer Nanostructured Titanium Oxide Photoelectrode and Manufacturing

Method Thereof. Taiwan Patent, I419392

2009

Title : Preparation and characterization of high density compact layer incorporated with

titania photoanode in dye-sensitized solar cell

2008

Title : Poly(oxyalkylene)diamine-Functionalized Carbon Nanotube/Perfluorosulfonated

Polymer Composites: Synthesis, Water State, and Conductivity. Chem. Mater., 20,

5756–5767

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