CHUNHUA PAN, Ph.D.

**** ******* **

Rockville, MD 20851

301-***-****

abn4xs@r.postjobfree.com

SUMMARY:

. Highly motivated, process and detail-oriented Analytical Chemist with

extensive experience in analytical and bioanalytical methods development

and validation under cGMP and GLP environments.

. Strong ability in USP-FDA-ICH regulation interpretation and SOPs writing

in compliance with regulations.

. Strong ability in coordination between personnel and/or departments and

lab management.

. Strong ability in scientific and data reviewing for plans, protocols,

notebooks and reports.

. Hands-on expertise in chromatography, spectroscopy and biochemical and

immunologic assays, including HPLC, LC/MS, GC, GC/MS, FT-IR, NIR, Raman,

UV-Vis spectrometer, SDS-PAGE, ELISA and western blots, IP, antibody

purification, protein purification.

. Proficient in QC testing for drug substances, drug products, dissolution

and chemical products.

. Proficient in developing, transferring and validating chromatographic and

spectroscopic methods for drugs (substances, products, dissolutions, and

excipients), foods and chemical products.

. Competent in evaluation of analytical data, procedures and acceptance

criteria.

. Unique capability in experimental planning, design, and implementation as

well as data generation and interpretation.

. Strong skills in methodology and instrumentation troubleshooting, and

problem solving.

EXPERIENCE:

Endo Pharmaceutical Co., Huntsville, Alabama, USA

2012 - present

Title: Sr. Scientist

. Develop GC and HPLC methods for deformulation, solving tough problems

that hindered the development of formulations for a long time, ensuring

product development moving forward.

. Develop GCMS and LCMS methods for extractable/Leachable testing.

. Develop and validate dissolution methods for oral suspensions, tablets in

compliance with FDA regulations.

. Develop and validate HPLC assay methods for drug substances and

excipients as well as related compounds.

. Lead and be engaged in method verification, method validation and QC

projects.

. Design validation protocols.

. Lead and be engaged in investigations of deficiencies and OOS, OOT.

. A key Reviewer of project plans, method designs, protocols and reports

for the whole R&D department, ensuring them in compliance with FDA

regulations.

. Lead or be involved in all troubleshooting activities, from methodology,

instrumentation to QC OOS investigations, saving big time and money for

company.

US. Pharmacopeia Convention, Rockville, Maryland, USA

2008 - 2012

Title: Scientist III

Developed and validated more than 20 projects as a project leader to

establish and verify the identity, potency and purity of drugs (APIs,

dissolutions, and excipients), foods, and flavors, most of which were

important projects for USP General Chapters.

. 9 HPLC methods: Planned, developed, optimized and validated these methods

for separation and assay of important drug APIs, degradants, and

impurities in liquid dosages and solid dosages, all of which became

official standard methods (USP monographs) or were under consideration

for monographs.

. 2 LCMS methods: These methods, which were developed for separation, assay

and identification of important drug APIs, degradants and impurities,

innovatively resolved the important issues that were concerned by the

FDA.

. 7 GC-FID and GC-MS methods for residual solvents: These methods were

developed for USP General Chapters <467> to determine residual solvents

in drug substances and drug products. Two peer-review articles were

published.

. 3 GCMS methods for flavors: Planned, developed, optimized and validated

these methods from the scratch to differentiate poisonous flavors from

edible flavors and assay the flavor contents, addressing mislabeling

issues in the flavor market

. 6 GC-FID methods for USP General Chapter <341> Antimicrobial Agents-

Content: Planned, developed, optimized and validated these methods to

determine the contents of preservatives in injectable products. The

poster presentation was made on EAS conference in November, 2011 and was

well recognized.

. Raman methods for skim milk powders: Collected hundreds of Raman spectra

for skim milk powders, which made significant contributions to the USP

spectral libraries.

. FT-IR and DSC methods for PET Pellets: Collected dozens of FTIR spectra

for PET pellets and PET films. Conducted differential scanning

calorimetry (DSC) studies for these PET pellets and films. This project

proposed an alternative reference standard for PET materials.

. Melting point project - an investigation for the development of potential

new USP Melting Point (MP) reference standards. It resulted in two new

potential reference standard materials.

. Assisted the project leaders in designing experiments and validation

protocols

. Provided scientific consultation to the development team

. Ensured that all proper experiments were conducted and suggested

additional work, if necessary

. Checked the data for errors and ensured that the methods were for

intended uses

. Evaluated the test procedures and acceptance criteria from a scientific

perspective

National Institutes of Health, Bethesda, Maryland, USA

2005 - 2008

Title: Postdoctoral Fellowship

Developed bioanalytical methods for proteoglycans (i.e. glycosaminoglycans)

and their core proteins in zebrafish and mice tissues by using LC/tandem MS

(i.e. LC/MS/MS).

. Developed methods to extract, isolate, separate, and purify

glycosaminoglycans and their core proteins by using IP, SDS-PAGE.

. Developed innovative tools for analyzing the heparan sulfate sugar

residues by LC/MSn and/or affinity MS

. Established proteomics approaches for studying glycosaminoglycan core

proteins. Seven unique core proteins were identified and characterized.

. Developed west-blot methods to characterize heparan sulfate core

proteins. An innovative ultra-sensitive and specific west-blot method was

successfully developed that could detect pg level of all (7) heparan

sulfate core proteins.

. Developed bioassay methods to quantitatively determine glycosaminoglycan

and their core proteins by ELISA.

University of Missouri, Kansas City, Missouri, USA

2000 - 2005

Doctoral graduate student, Department of Chemistry

Conducted theoretical and experimental investigations on structure and

properties of novel silicon containing organic molecules using FT-IR and

Raman technologies with computational simulation, which resulted in 18

papers published in international journals and books.

. Synthesized a series of novel organic molecules.

. Purified these molecules by low-temperature and low-pressure

fractionation columns.

. Identified and checked purities by MS and/or FT-IR.

. Predicted theoretical frequencies by ab initio calculations.

. Carried out vibrational assignments, conformational stability analyses by

a series of temperature dependent experiments using FT-IR and Raman

technologies.

Beijing Chemical Industry Group Co., Beijing, P. R. China

1991 - 1999

Director, senior engineer, Department of Environmental Monitoring (1994 -

1999)

. Oversaw more than 20 employees. Reviewed raw data, evaluated & analyzed

technical results. Wrote final reports to VP. Wrote SOPs and regulations

for laboratories. Checked and ordered chemicals and equipment supplies.

. Developed & validated dozens of methods in HPLC, LC/MS, GC, GC/MS, AA, UV-

visible

. Evaluated and modified dozens of analytical methods.

. Transferred several methods, assisting new production lines to meet test

requirements and ensuring that timelines were met.

. Maintained and repaired laboratory equipment, achieving cost/time

savings.

. Developed and built an environmental monitoring station with a budget of

$3M.

. Identified incorrectly labeled latex products using LC/MS, FT-IR and

other technologies, saving company at least $20,000.

. Responsible for coordinating analytical work and personnel among

departments in a large joint project with a Japanese company ($1M),

greatly improving efficiency and ensuring that timelines were met.

Engineer, QA/QC Center (1991 - 1994)

. Conducted QA/QC analyses using HPLC, LC/MS, GC, GC/MS, AA, AE, GC-FTIR,

UV-visible, and wet chemistry.

. Conducted data analyses and wrote final technical reports.

Beijing Hongxing Pharmaceutical Company, Beijing, China

1987 - 1988

Intern, QA/QC Center

. Conducted QA/QC analyses of stability, dissolution, and active

ingredients.

EDUCATION:

Ph. D., Analytical & Physical Chemistry with computer science as minor,

2005

University of Missouri, Kansas City, Missouri

M. S., Environmental Monitoring, 1991

Beijing Institute of Light Industry, Beijing, P. R. China

B. S., Analytical Chemistry, 1988

Beijing University of Chemical Technology, Beijing, P. R. China

ADDITIONAL EXPERIENCE:

Reviewed 246 papers for "Spectrochimica Acta Part A: Molecular and

Biomolecular Spectroscopy".

SKILLSETS:

Analytical Methods Development and Validation: For small molecule drugs,

foods, flavors and chemicals with great efficiency using the techniques

listed below.

. High Performance Liquid Chromatography (HPLC) methods development and

validation:

o Reverse phase liquid chromatography (RPLC)

o Normal phase liquid chromatography

o Chiral chromatography

o Ion-pairing RPLC

o Hydrophilic interaction chromatography (HILIC)

o Ion-exchange chromatography (IC)

o Size-exclusion chromatography (SEC)

. Liquid Chromatography-Mass Spectrometry (LC/MS) methods development and

validation:

o LC-ESI or APCI MS with ion trap, triple quadrupole, TOF, and MALDI

. Gas chromatography (GC) methods development and validation:

o Thermo desorption

o Static headspace

o Solid phase microextraction (SPME)

o GC-FID, TCD, NPD and ECD

. Gas chromatography-mass spectroscopy (GC/MS) methods development and

validation

. Dissolution:

o Appratus I, II and III.

. Spectroscopy:

o AA

o AE

o UV-visible

o FTIR

o NIR

o Raman

. Bioanalytical methods development:

o Immunoprecipitation (IP)

o SDS-PAGE

o Western-blot

o In-gel digestion

o ELISA

ABSTRACTS and PRESENTATIONS:

1. Gamil A. Guirgis, Chunhua Pan, and James R. Durig, "Vibrational

Investigation of the Conformational Stability, Vibrational Assignment and

Ab initio Calculations of Ethylmethylsilane and Ethylmethyl-

difluorosilane", in XXVI European Congress on Molecular Spectroscopy,

edited by Sylvia Turrell and Olivier Poizat, University des Science et

Technologies de Lille, 1-6 September 2002, p86.

2. James R. Durig, Chunhua Pan, Tarek A. Mohamed, and Gamil A. Guirgis,

"Raman and Infrared Spectra, Conformational Stability, Vibrational

Assignment and Ab initio Calculations of n-Propylsilane and n-

Propyltrifluorosilane", in XXVI European Congress on Molecular

Spectroscopy, edited by Sylvia Turrell and Olivier Poizat, University des

Science et Technologies de Lille, 1-6 September 2002, p350.

3. James R. Durig, Chunhua Pan, Shiyu Shen, and Gamil A. Guirgis, "Raman

and Infrared Spectra, Conformational Stability, and Ab initio

Calculations of Some Organosilanes", in Proceedings of XVIIIth

International Conference on Raman Spectroscopy, edited by Janos Mink,

Gyorgy Jalsovszky, and Gabor Keresztury, 25 - 30 August, 2002 Budapest,

Hungary, Wiley, p95.

PUBLICATIONS:

1. Alyssa Ashley, Jennifer Belsky, Heather Joyce, Chunhua Pan, Horacio

Pappa and Samir Wahab, "Static headspace GC-MS detection of residual

solvents - a possible simultaneous identification and quantitation

method", LCGC North America, 30 (1), 64 (2012).

2. Jennifer Belsky, Alyssa Ashley, Premal Bhatt, Karen Gilbert, Heather

Joyce, Chunhua Pan, Horacio Pappa and Samir Wahab, "Optimization of the

Water-Insoluble Procedures for USP General Chapter Residual Solvents

<467>," AAPS Pharm SciTech. 11 (2), 994 (2010).

3. Chunhua Pan, Pengqian Zhen and Gamil A. Guirgis, James R. Durig,

"Conformational and structural studies of 1-Fluorosilacyclobutane from

temperature dependent FT-IR spectra of krypton solutions and ab initio

calculations," J. Mol. Struct., 800, 106 (2006).

4. Chunhua Pan, Gamil A. Guirgis, James R. Durig, "Infrared and Raman

Spectra, Conformational Analysis, Ab Initio Calculations and Vibrational

Assignment of 2-chloroethylsilyl Chloride," J. Mol. Struct. 742, 199

(2005).

5. James R. Durig, Chunhua Pan, Witold Witkowski and Gamil A. Guirgis,

"Conformational Stability, Infrared and Raman Spectra, and Vibrational

Assignment of Ethyl Bromogermane," Canadian J. Chem., 82, 964(2004).

6. James R. Durig, Chunhua Pan and Gamil A. Guirgis, "Spectra and Structure

of Silicon Containing Compounds XLI. Infrared and Raman Spectra,

Conformational Stability, Ab initio Calculations and r0 Structural

Parameters of Ethylmethylsilane", J. Mol. Struct. 688, 95 (2004);

7. G. A. Guirgis, Chunhua Pan and James R. Durig, " Conformational

Stability, Vibrational Assignment, and Ab initio Calculations of

Cyclopropylsilyl Bromide", J. Mol. Struct. 657, 239 (2003).

8. James R. Durig, Chunhua Pan and Gamil A. Guirgis, "Spectra and Structure

of Silicon Containing Compounds. XL. Infrared and Raman Spectra,

Conformational Stability, Vibrational Assignment and Ab initio

Calculations of Ethylmethylsilyl Difluoride", J. Mol. Struct. 656, 287

(2003).

9. James R. Durig, Chunhua Pan, Peter Klaeboe, Valdemaras Aleksa and Gamil

A. Guirgis, "Spectra and Structure of Silicon Containing Compounds.

XXXIX. Raman and Infrared Spectra, Conformational Stability, Vibrational

Assignment and ab initio Calculations of n-Propyltrifluorosilane,"

Spectrochim. Acta, 59A, 2151 (2003).

10. Douglas T. Durig, Zhenhong Yu, Chunhua Pan and James R. Durig,

"Conformational Stability from Variable Temperature Infrared Spectra of

Rare Gas Solutions of 2-Chloro-3-Fluoropropene," Spectrochim. Acta, 59A,

1579 (2003).

11. James R. Durig, Chunhua Pan and Gamil A. Guirgis, "Spectra and

Structure of Silicon Containing Compounds. XXXII. Raman and Infrared

Spectra, Conformational Stability, Vibrational Assignment and Ab Initio

Calculations of n-Propylsilane-d0 and Si-d3," Spectrochim. Acta, 59A, 979

(2003).

12. Gamil A. Guirgis, Chunhua Pan and James R. Durig, "Spectra and

Structure of Silicon-Containing Compounds. XXXIII. Raman and Infrared

Spectra, conformational Stability, Vibrational Assignment of Chloromethyl

Silyl Bromide," J. Raman Spectrosc., 33, 677 (2002).

13. James R. Durig, Chao Zheng, Chunhua Pan, Shiyu Shen and Gamil A.

Guirgis, "Utilizing Raman Spectroscopy for the Determination of

Conformational Stabilities of Some Silicon-Containing Compounds," Chinese

J. Light Scatt., 14, 2 (2002).

14. James. R. Durig, Chunhua Pan and Gamil A. Guirgis, "Conformational

Stability of Ethyl Chlorogermane from Temperature Dependent FT-IR Spectra

of Krypton Solutions and r0 Structural Parameters of Methyl Chlorogermane

and Ethyl Germane," J. Mol. Struct., 607, 117 (2002).

15. Gamil A. Guirgis, Chunhua Pan and James R. Durig, "Spectra and

Structure of Silicon-Containing Compounds. XXX. Raman and Infrared

Spectra, Conformational Stability, Vibrational Assignment of Chloromethyl

Silyl Dichloride," Spectrochim. Acta, 58A,1839 (2002).

16. Gamil A. Guirgis, Chunhua Pan, Shiyu Shen and James R. Durig, "Variable

Temperature FT-IR of Krypton Solutions and ab initio Calculations of

ClCH2SiH2X (X=F, Cl, Br)," Asian J. Spectrosc., 5, 113 (2001).

17. G. A. Guirgis, Chunhua Pan, S. Shen and James R. Durig, "Conformational

Stability of Chloromethyl Silyl Chloride from Temperature Dependent FT-

IR Spectra of Krypton Solutions," Struct. Chem., 12, 445 (2001).

18. Yaming He, Chunhua Pan and Shubin Xing, "Kinetic determination of

fructose in the presence of glucose by ion-selective electrode flow

injection analysis", Fenxi Huaxue 22, 67 (1994).

REFERENCES- Available Upon Request

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