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Analytical Chemistry

Location:
Fullerton, CA, 92832
Posted:
February 02, 2019

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Resume:

Charlie (Changming) Yang

Phone in U.S.A.: 949-***-****

E-Mail: ac8dim@r.postjobfree.com

SUMMARY:

Managerial experiences in team leadership. Project management experiences in studies design, plan, conduction, conclusion, and transferring.

Contract Research Organization (CRO) experiences, good knowledge of cGMP, GLP and FDA regulations for pharmaceutical industry. Authorships of SOP and Validation Protocols per industrial regulations.

Ph.D in Analytical Chemistry, with expert knowledge in HPLC, LC/MS/MS, ICP-MS, Capillary Electrophoresis, SDS-PAGE, Spectrophotometry and related platforms for the analysis and characterization of small molecules and large molecules.

Over 15 years of experience in analytical method development and validation for clinical and pharmaceutical testing.

EDUCATION

Aug, 1999 Aug, 2000: Postdoctoral research work at Cornell University with focus on LC/MS/MS analysis of small molecule drugs (Supervisor: Dr. Jack Henion)

Aug, 1995 July, 1999: Ph.D. degree in Analytical Chemistry (Supervisor: Dr. Ziad El Rassi), Oklahoma State University, U. S. A.

July, 1983 July, 1987: B.Sc. degree in Chemistry, Nanjing University, P. R. of China.

EXPERIENCE

WuXi AppTec Co., Ltd.

Bioanalytical Services (BAS) Department

Laboratory Testing Division

Senior Director 10/2016 Present

Managing three teams of staff (total head count 50) in daily operations. Two teams are for international clients clinical bioanalytical testing studies (bioanalytical assay development/validation and sample analysis using LC/MS/MS), the other team provides method development support to mass spectrometry operation to the whole BAS department.

Involved in the testing facility management (TFM) for the three teams GLP (FDA, OECD, and CFDA) compliance, liaison with international study monitors, staff recruitment and career advancement, and teams budget planning.

Irvine Pharmaceutical Services (Now Nitto Avecia Pharma Services), Irvine, CA

Elemental Analysis

Supervisor 8/2014 – 9/2016

Supervised a group of staffs in routine QC tests of metals in drug products, drug substances, and raw materials per USP, EP, and JP, using Flame AA, ICP-OES, and ICP-MS;

Directed the R&D activities of the group for method development and validation for elemental analysis per USP <232> and USP <233>.

Irvine Pharmaceutical Services (Now Nitto Avecia Pharma Services), Irvine, CA

Structural Chemistry

Senior Scientist 9/2011 7/2014

Conducted GMP assay development/validation for drug raw material, drug substance, drug products, and medical devices in CMC related testing. Below are representative examples.

Stability test: Leading scientist for the method development and validation to quantify the amino acid degradants in Baxter s drug product, using UPLC/MS/MS (Waters Accquity and API 4000).

Deformulation test: Leading scientist for the method development to quantify polysorbate 20 (PS20) as raw material and in biopharmaceutical formulation, using HPLC charged aerosol detection (HPLC-CAD).

Extractable and leachable: Leading scientist for the method development and validation to quantify leachable tri-nonylphenyl phosphate (TNNP) and nonylphenol (NP) in Terumo s ACD-A injectable solution, using LC/MS (Agilent 1100 and API 4000) detection.

Stability test: Leading scientist for the method development and validation to quantify the active pharmaceutical ingredient and to identify impurities/degradants in forced degradation of Amicu s AT2220 drug product, using LC/MS (Agilent 1100 and API 4000) detection.

Extractable and leachable: Leading scientist for the method development and validation to quantify leachable Irgafos 168 and Irgafos 168 phosphate in Pfizer s CMC-544 and Mylotarg drug products and substances, using HPLC/UV detection.

FTE: In a cGMP environment, took the lead in a full-time-equivalent (FTE) project for Hyland s (Standard Homeopathic Company). This includes method development and validation for QC tests and quantitative determination of Atropine and Scopolamine in Hyland s Teething Tablets, Teething Gels, Teething Gel Premixes, and Belladonna Powders, using LC/MS (Agilent 1200 HPLC and API 4000 Mass Spectrometer). Coordinated in the project management between the company and the client. Also developed and validated a HPLC-UV method for the quantitative determination of sodium benzoate in Hyland s coughing syrup and ear-drop liquid.

Conducted Gas Chromatography (GC) analysis and moisture analysis (Karl Fischer titration).

Quest Diagnostics Inc., San Juan Capistrano, CA

R&D Endocrinology

Senior Research Scientist 7/2008 – 8/2011

Research Scientist 2/2005 6/2008

Conducted assay development/validation for clinical diagnosis using HPLC, LC/MS/MS, and ICP-MS. Below are representative examples.

Small Molecule Projects: Developed/Validated quantitative LC/MS/MS assays (for small molecules) include: (1) Analysis of reverse triiodothyronine (reverse T3, or rT3); (2) Determination of Thiopurine Methyltransferase (TPMT) Enzyme Activity by LC/MS/MS. An API 2000 was used for this assay, with ESI as ion source; (3) LC/MS/MS Quantitation of Vitamin D metabolites (including vitamin D2 and vitamin D3) in Human Serum; (4) On-line Extraction and Analysis of Riboflavin (vitamin B2) in Human Plasma by LC/MS/MS. Thermo Quantum Ultra triple quadrupole mass spectrometer was used for assays (1), (3) and (4), with HESI, APCI and ESI ion sources for rT3, vitamin D and riboflavin projects, respectively.

Large Molecule Projects: Conducted exploratory proteomic studies on Fibroblast Growth Factors 21 and 23 (FGF 21 and FGF 23). Used SDS-PAGE, in-gel digestion, in-solution digestion, and Western Blot for protein/peptide purification and identification. Also used Eksigent micro-LC and Thermo LTQ XL Ion Trap mass spectrometer for protein and fingerprint peptide identification and characterization.

Elemental Analysis: Conducted assay development and validation with Inductively Coupled Plasma (ICP) mass spectrometer for the quantitative analysis of trace amount metal elements (As, Cd, Hg, Pb, V, Mn, Co, Sr, Mo, Tl, and Bi). A Perkin-Elmer ICP-DRC mass spectrometer was used for these projects.

Mentored and technically supervised Clinical Chemistry Scientists (CLS) in method transfers.

Harvard Medical School, Boston, MA

Massachusetts General Hospital

Wellman Laboratories of Photomedicine

Research Fellow 8/2003 - 2/2005

Research and development of bioconjugates (small or large molecules) for photodynamic treatment, provided analytical chemistry expertise in HPLC (reverse-phased, ion-exchange, and size exclusion), capillary electrophoresis (with UV photodiode array or laser-induced fluorescence detections), and SDS-PAGE.

Neogenesis Pharmaceuticals, Inc. (Now part of Merck), Boston, MA

Senior Scientist 2/2002 - 7/2003

High throughput drug candidate discovery using Neogenesis proprietary drug discovery platform, Auto Ligand Identification System (ALIS). Special technical skills required for ALIS are: (1) size exclusion liquid chromatography (SEC LC, Agilent 1100), (2) reverse phase liquid chromatography (RPC LC, Agilent 1100), (3) liquid chromatographic system interfaced with mass spectrometer (Micromass LCTof or Q-Tof), and (4) automation for sample preparation.

Northeastern University, Boston, MA

Post-Doctoral Associate 9/2000 - 1/2002

Conducted post-doctoral research on DNA adducts using capillary electrophoresis using laser induced fluorescence detection approach.

Cornell University, Ithaca, NY

Post-Doctoral Associate 8/1999 - 8/2000

Conducted post-doctoral research on small molecule drug and drug metabolites in biological matrices with LC/MS/MS using photo-ionization approach.

Oklahoma State University, Stillwater, OK

Ph.D graduate student 7/1995 - 7/1999

Ph.D graduate student with major in analytical chemistry.

Jiangxi University (now Nanchang University), Nanchang, Jiangxi, China

Teacher 7/1987 - 7/1995

Conducted teaching and research in Department of Chemistry, Jiangxi University.

Nanjing University, Nanjing, Jiangsu, China

Undergraduate Student 7/1983 - 7/1987

Undergraduate student with major in chemistry.

Patent

US 8399829: On-line Extraction LC/MS/MS Quantitative Analysis of Riboflavin (vitamin B2) in Human Plasma

Publications:

1. Macrophage-targeted photosensitizer conjugate delivered by intratumoralinjection , Anatelli F, Mroz P, Liu Q, Yang C, Castano AP, Swietlik E, Hamblin MR. Mol Pharmaceut. 6: 654-664 (2006).

2. Helicobacter pylori Accumulates Photoactive Porphyrins and Is Killed by Visible Light , Michael R. Hamblin, Jennifer Viveiros, Changming Yang, Atosa Ahmadi, Robert A. Ganz, and M. Joshua Tolkoff. Antimicrob Agents Chemother. 49(7): 2822 2827 (2005).

3. Handling-Detection of 8 Attomoles of a Near-IR Heptamethine Disulfonate Dye by Capillary Electrophoresis with Laser Induced Fluorescence Detection , Changming Yang, Olga Ivanova, Gabor Patonay and Roger W. Giese. J. Chromatogr. A., 979, 307-314 (2002).

4. Atmospheric Pressure Photoionization LC/MS Determination of Idoxifene and Its Metabolites in Human Plasma , Changming Yang, and Jack Henion. J. Chromatogr. A., 970, 155-165 (2002).

5. Electrically Driven Microseparation Methods for Pesticides and Metabolites. III. Capillary Electrochromatography with Novel Silica-based Stationary Phases Having a Surface-bound Surfactant Moeity , Changming Yang, and Ziad El Rassi, Electrophoresis, 21, 1977-1984(2000).

6. Electrically Driven Microseparation Methods for Pesticides and Metabolites. II. On-line and Off-line Preconcentration of Urea Herbicides in Capillary Elecrtrochromatography , Changming Yang, and Ziad El Rassi, Electrophoresis, 20, 2337-2342 (1999).

7. Capillary Electrochromatography with Novel Stationary Phases. Retention Behavior of Small and Large Nucleic Acids on Octadecyl-sulfonated-silica . Minquan Zhang, Changming Yang, and Ziad El Rassi, Anal. Chem., 71, 3277-3282 (1999).

8. Capillary Electrochromatography with Segmented Capillaries for Controlling Electroosmotic Flow . Changming Yang, and Ziad El Rassi, Electrophoresis, 20, 18-23 (1999).

9. Capillary Zone Electrophoresis of Proteins with Fused-Silica Capillaries Having Polymers and Surfactants Adsorbed onto Surfactant Moieties Previously Covalently Bound to the Capillary Column Surface. Changming Yang, and Ziad El Rassi, Electrophoresis, 19, 2278-2284 (1998).

10. Capillary Electrochromatography of Derivatized Mono- and Oligosaccharides. Changming Yang, and Ziad El Rassi, Electrophoresis, 19, 2061-2067 (1998).



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