James Y. Huang, Ph. D.

** **** **** **.

Hockessin, DE 19707

Phone: 302-***-****(Cell)

E-mail: adytiu@r.postjobfree.com

PROFILE

Highly creative and motivated scientist in organic pharmaceutical field.

Experience in Drug Discovery, chemical toxicology, Chemical Process Development and GMP/non-GMP manufacture, Drug Impurity/Degradant/Metabolite ID and Synthesis, Analytical R&D and sample assay, Formulation R&D and manufacturing.

Familiarity with operation/data analysis of NMR, HPLC, LC/MS/MS, GC/MS, FTIR, UV, etc.

Familiarity with relevant biological disciplines and good collaboration / interaction with a broad group of internal and external scientists in relevant disciplines like medicinal/organic chemistry, analysis, pharmacology, toxicology, regulatory, QC, QA

Good laboratory practice and high safety standards; Strong skills in scientific / technical troubleshooting, computer and chemistry databases SciFinder and Beilstein

Excellent team player in a diverse team of co-workers with good verbal and written communication skills, independent but cooperative, quiet but with sense of humor

Professional experience

Mar.2011- Present, Head and Senior Scientist of Synthesis Department, Chem Service, Inc, West Chester, PA

Responsibilities including monitoring and maintaining the operation of department. Developing process to improve the quality and innovation of the company's product.

Directing the professional activities of department.

Synthesizing bioactive compounds, metabolites, and other organic chemicals.

Specialist and responsible to Company supply chain.

Jan. 2008- Feb. 2011, Senior Scientist, Frontage Laboratory, Malvern, PA

Chemical Development and GMP/non-GMP manufacture: Experience in design, execution, evaluation, optimization of organic syntheses, purification, and crystallization, process suitable and greener for scale-up and manufacture of APIs under cGMP

Drug Impurity/Degradant/Metabolite ID and Synthesis: Isolation impurity/degradant/ metabolite from original or forced drug substances, biological fluids and tissues or enzymatic reaction by LC; structure identification of impurities, degradants and metabolites of interest and confirmation by classical organic synthesis and enzymatic reaction

Custom synthesis: milligram to kilogram scales for reference compounds, building blocks, intermediates and stable isotope labeled compounds

Analytical R&D and sample assay: by various instruments such as LC/MS, HPLC, GC/MS, UV, IR, NMR, etc., providing analysis and purification of high quality and efficiency, including high throughput analysis and purification; structure elucidation; physicochemical properties determination; enantiomeric analysis and purification at both analytical and preparative scales; method development of in-process-controls; assay development of drug substances and drug products as well as method validation; impurity and degradation product characterizations; testing of reagents, starting materials, intermediates, and final products, stability of drug substances and drug products, dissolution and titration. Familiarity with Empower and Waston data acquisition software

Preformulation Development: Salt screening and selection, Polymorph screening and form selection, Solubility in various media, Permeability, Solution and solid state characterizations, Crystallinity evaluation, Compatibility, Stability studies, Amorphous Stabilization, Drug-excipient Interaction

Preparing detailed project working plans, evaluating and troubleshooting technical issues related drug development and manufacture

Providing technical guidance to junior staff and interacting with clients to solve technical issues, writing technical reports, presenting results at meetings with clients

Jan. 2005- Dec. 2007, Principal Research Chemist, Wilmington Pharmatech, Newark, DE

The responsible work including Chemical Process Development and GMP/non-GMP manufacture, Custom synthesis, Analytical R&D and Preformulation Development.

Dec. 2002- Dec. 2004, Senior Chemist, Adesis Inc. New Castle, DE

The responsible work including Custom synthesis and Process development.

Nov. 1998 – Nov. 2002, Research Scientist, Department of Chemistry and Pharmacology, State University of New York at Stony Brook

Genotoxicology studies: Synthesis of carcinogenic substances in Nucleosides, Nucleotides & Nucleic Acids for chemical genotoxicology research; DNA damage and repair mechanism research. Assessment of genotoxic and mutagenic effects of chemical compounds in organisms.

September 1996 – October 1998: Postdoctoral Research Fellow, Organic Pharmaceutical Chemistry, Uppsala University, Uppsala Biomedical Center, Uppsala, Sweden.

Utilizing medicinal chemistry as well as SAR principles for hit-to-lead and lead optimization, design and syntheses of bioactive compounds for treatment of drug dependency and CNS, two patents issued from these research

Education

1996: Ph.D. in Medicinal Chemistry, Institute of Materia Medica, Chinese Academy of Medical Sciences, Beijing, China.

Total synthesis of natural product ligustiphenol as lead compound for anti-inflammatory and anti-immunology

Utilizing medicinal chemistry as well as SAR principles for hit-to-lead and lead optimization, design and syntheses of analogues of ligustiphenol for pharmacological screening

1992: MS in Medicinal Chemistry, China Pharmaceutical University, Nanjing, China.

Utilizing medicinal chemistry as well as SAR principles for hit-to-lead and lead optimization, design and synthesis of a series of new N-benzoylethyltetrahydroisoquino-lines for studies of cardiovascular activity

Awards

Ministry of Public Health Award (1998) in recognition of contributions to the advancement of medical science & technology in People’s Republic of China

Professional Activities

American Chemical Society

The international Union of Pure and Applied Chemistry

New York Academy of Sciences

Publications, Patent and Presentations

1.Patent: PROCESSES FOR THE PREPARATION OF O-[5-(4-AMINO-THIAZOL-2-YL)-PYRIDIN-2-YLMETHYL]-HYDROXYLAMINE; US: 200********

2.Patent: Method of Producing 6-Substituted (s)-Nicotine Derivatives and Intermediate Compounds; WO: 01/70730

3.Patent: Nicotine Immunogen; WO: 99/61054

4.Tianle Yang, Yanhe Huang, and Bongsup P. Cho, Synthesis and Characterization of Enantiomericanti-2-Fluorobenzo[a]pyrene-7,8-dihydrodiol-9,10-epoxides and their 2'-Deoxy-guanosine and Oligodeoxynucleotide Adducts, Chem. Res. Toxicol., 2006, 19(2), 242 - 254.

5.Yanhe Huang and Francis Johnson, Regioselective Synthesis and the Generation of 1, N2-Etheno-2’-Deoxyguanosine in Oligomeric DNA, Chem. Res. Toxicol., 2003, 16(6), 708-714.

6.Yanhe Huang and Francis Johnson, Synthesis of the Minor Acrolein Adducts of 2’-Deoxygua-nosine and Their Generation in Oligomeric DNA, Bioorganic Chemistry, 2003, 32 (2), 136-148

7.In-Young Yang, Grace Chan, Holly Miller, Yanhe Huang, Maria Cecilia Torres, Francis Johnson, and Masaaki Moriya Mutagenesis by Acrolein-derived Propanodeoxyguanosine adducts in Human Cells, Biochemistry, 2002, 41, 13826-32.

8.Yanhe Huang and Francis Johnson, Regioselective 1-Alkylition of 2’-deoxyguanosine, Nucleosides, Nucleotides & Nucleic Acids, 2002, 21(6&7), 435-447.

9.Yanhe Huang and Francis Johnson, Regioisomeric Synthesis and Characteristics of the a-Hydroxy-1, N2 propanodeoxyguanosine, Chem. Res. Toxicol, 2002, 15(2), 236.

10.Yanhe Huang, Concerning the Solvent Effect in the Aldol Condensation, Monatschefte für Chemie, 131 (2000) 5, 521-523.

11.Yanhe Huang and RW Hartmann, The improved preparation of 7,8-dihydro-quinoline-5 (6H)-one and 6,7-dihydro-5H-1-pyridin-5-one, Synth. Comm., 1998, 28(7), 1197-1200.

12.ZQ Yao, Q Guo, and YH Huang, Officinalisin, a new compound from root-barks of Morinda Officinalis How., Chinese traditional and herbs drugs, 1998, 29(4), 217.

13.YH Huang and DQ Yu, Studies on the synthesis of dl-liqustiphenol and its analogues. Acta Pharm. Sinica, 1997, 32 (9), 675-681.

14.YH Huang and DQ Yu, Total synthesis of dl-liqustiphenol, Chinese Chem. Lett., 1996, 7(10): 896 (CA126: 31499u)

15.DQ Yu, FZ Xie, RY Chen and YH Huang, Studies on the structure of ligustiphenol from Ligusticum Sinence Oliv., Chinese Chem. Lett., 1996,7(8):721(CA 125: 297035n)

16.Y Huang, L Wang and J Huang, Studies on the synthesis of Fluoxetine. Chinese J. Med. Chem., 1996,6(1): 56 (CA 125: 158449n)

17.YH Huang, LC Wang and JZ Huang, Synthesis and cardio-vascular activity of N-benzoylethyltetrahydroisoquino-lines. Acta Pharm. Sinica, 1995,30(4):269 (CA 123: 83180r)

18.Yanhe Huang and Francis Johnson, New Regioisomeric Synthesis of the 1, N2-Exocyclic Adduct of Vinyl Chloride with 2’-Deoxyguanosine and Its Incorporation into Oligomeric DNA. 224th National American Chemical Society Meeting, Aug. 18-22, 2002, Boston.

19.M. Cecilia Torres, Yanhe Huang, Radha R. Bonala, Deepak S. Tawde, Francis Johnson and Charles R. Iden, Efficient HPLC separation of diastereomers of modified oligodeoxynucleotides, 224th National American Chemical Society Meeting, Aug. 18-22, 2002, Boston.

20.Yanhe Huang and Francis Johnson, Regioisomeric Synthesis and Characterization of the 6-hydroxy-Exocyclic Adducts of Acrolein with 2’-Deoxyguanosine in Oligomeric DNA, 223rd National American Chemical Society Meeting, Apr. 07-11, 2002, Orlando.

21.TL Yang, YH Huang and BP Cho, Preparation of enantiomerically pure anti-diolepoxides of 2-fluorobenzo[a]pyrene as the Model 19F NMR Probes, 222nd National American Chemical Society Meeting, August 27-30, 2001, Chicago.

22.YH Huang and BP Cho, Preparation of anti-Diol Epoxides of 2-fluorobenzo[a]pyrene as the Model 19F NMR Probes, the XXV Symposium of North East Regional Medicinal Chemistry and Pharmacognosy (NERMCAP), June 2-3, 2000, Stoors, CT 06269.

23.YH Huang, LC Wang and JZ Huang, Synthesis of N-benzoyl-ethyltetrahydroisoquinolines, the Second International Symposium for Chinese Organic Chemists, August 24-27, 1992, Beijing.

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