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SUMMARY OF QUALIFICATIONS
A M.S. in Analytical Chemistry with 15 years experience in pharmaceutical R&D and analytical
laboratory. A skillful analytical chemist and task leader in method development, validation, transfer,
and modification for the drugs in different dosage forms using a variety of chromatography,
spectroscopy, NGI, ACI, and wet chemistry techniques. A well-experienced scientist with
comprehensive knowledge of cGMP and cGLP regulations. Dedicated and detail-oriented
professional with outstanding problem-solving, time-management, communication, and
presentation skills. Dependable self-starter and team player who maintains order and assures safe
work practices to complete tasks with efficiency and effectiveness.
LABORATORY SKILLS
HPLC; GC; UV/Vis; Karl Fischer; Dissolution System; NGI (Next Generation Impactor); ACI
(Andersen Cascade Impactor); Dry Powder Insufflator; Digital Fluorometer; FT-IR; HPLC/MS;
GC/MS; TLC; TGA; XRD
COMPUTER SKILLS
Microsoft Word; Microsoft Excel; Empower2; Millennium32; Turbochrom; ChemWindow
ChemDraw; SigmaPlot; EZChrom
PROFESSIONAL EXPERIENCE
MicroDose Therapeutx, Inc. 02/2007 — 02/2010
Scientist in analytical R&D
Develop HPLC methods for assay, impurity, stability, Particle Size Distribution (PSD), and
Delivered Dose Uniformity (DDU) testing.
Perform method transfer and modification.
Write study designs, experimental plans, technical memorandums, and final reports for assay,
potency, Blend Uniformity (BU), blend stability, solution stability testing, and PSD testing using
NGI, DDU and Gravimetric Clearance (GC) testing using Copley tube.
Develop, revise, or review SOPs and test procedures.
Perform and Lead analytical group to perform assigned tasks, such as assay, potency, Blend
Uniformity (BU), blend stability, solution stability, PSD, DDU, and GC tests.
Perform device feasibility tests for electronic and passive dry powder inhalers and insufflator.
Perform drive scheme optimization tests for electronic dry powder inhalers.
Perform technical training for junior staff scientists.
1
Cardinal Health, Somerset, New Jersey 8/2005 – 11/06
Scientist in analytical R&D
Conduct elution, residual solvent, and identification tests for medical device/drug combination
product using HPLC, GC, and UV.
Perform method development and validation for dissolution, HPLC assay, and impurity assay
for specificity, accuracy, precision, linearity, LOQ, and LOD tests for tablet and softgel capsule
products.
Perform method evaluation for HPLC assay and degradation products and dissolution.
Conduct stability and release tests for tablet and softgel capsule products using HPLC, Karl
Fischer, disintegration apparatus, and dissolution apparatus.
Perform data review as a qualified data reviewer.
Handle multiple complex projects simultaneously.
Project manage teams to efficiently complete tests.
Use TrackWise system to generate PR reports.
Perform analytical method development and validation for particle size distribution, assay,
impurity, and equipment cleaning tests.
Conduct analytical testing for clinical support for assay, identification, impurity, uniformity,
particle size distribution, moisture content, fill weight and description, and the determination of
APHA number tests for Dry Powder Inhaler (DPI) products using HPLC, Karl Fischer,
Cascade Impactor, TLC, FTIR, UV, and other instruments under cGMP regulated
environment.
Produce validation reports, special study and method modification protocols and reports.
Train analysts for Particle Size Distribution, TLC, and Moisture tests and using Turbochrom
and Millennium32 system for data analysis.
Use LIMS to process data and generate reports.
Use TrackWise system to generate OOS reports.
2
Conduct analytical R&D, developing and validating methods for drug substance and product in
following areas:
• Develop analytical method of HPLC, GC, TLC, UV, IR, and dissolution for assay, impurity,
formulation development and screening, cleaning validation, or identification.
Perform product stability test, product release test, and vendor qualification test.
Produce validation reports of analytical methods.
3
Operate department HPLC/MS and GC/MS, serving faculty and graduate students from five
departments.
Conduct routine HPLC/MS and GC/MS instrument maintenance and minor repairs.
Assist in the interpretation of mass spectra.
EDUCATION
Kansas State University, Manhattan, Kansas
Master of Science, Analytical Chemistry, 1996
PUBLICATION/PRESENTATIONS
Jiang, Y.; Decker, S; Mohs, C. and Klabunde, K.J., “Catalytic Solid State Reactions on the Surface
of Nanoscale Metal Oxides Particles,” J. Catalysis, 180, 24-35(1998).
Klabunde, K.J.; Stark, J.V.; Koper, O.; Mohs, C.; Park, D.; Decker, S. and Jiang, Y., “Nanocrystals
as Stoichiochiometric Reagents with Unique Surface Chemistry” Phys. Chem., Vol. 100, pages
12142-12153, 1996. Projector no. 89-26, 92-03.
Klabunde, K.J.; Park, D.G.; Stark, J.; Koper, O.; Decker, S.; and Jiang, Y. “Nanoscale Metal Oxides
as Destructive adsorbents: New Surface Chemistry and Environmental Applications,” NATO
Meeting on Fine Particles Science and Technology, Kluwer Academic Pub., pages 691-706, 1996.
Project no. 89-26, 92-03.
Jiang, Y., “Destructive Absorption of Carbon Tetrachloride on Transition Metal Coated Magnesium
Oxide”. Poster in Middle-West Analytical Conference.