Director of Pharmaceutical Analysis, Drug Delivery

Michael Yang, Ph. D.

*********@*****.***

Phone: 718-***-****

HIGHLIGHT

Hand-on working experience in analytical instruments: HPLC, GC, Prep-HPLC, UPLC, LC/MS, GC/MS, MS/TOF, LC/MS/MS, UV. FTIR, NIR, NMR, Raman, and related instrumental software: Empower, Chemstation, Masslynx, Analyte and MultiChrom

Managerial experience in analytical R&D and QC functions as team leader, group leader, principal scientist and director of AR&D.

EXPERTISE

Development and validation of analytical methods for pharmaceutical drug substances, drug products, and drug delivery in compliance with cGMP, ICH regulations.

Isolation and identification of pharmaceutical impurities for extractables and leachables under GLP, ICH regulations

Characterization and stability testing of drug products for different doses based on ICH, FDA guidelines.

EDUCATION

Ph.D. Dept. Biophysics, Yeshiva university, Albert Einstein College of Medicine Bronx, NY, 1997

M. S. Dept. of Chemistry, New York University New York, NY, 1992

M. S. Dept. Nuclear Science, Chemistry, Fudan University, Shanghai, China, 1985

WORK EXPERIENCE

2011 - present: Director, analytical laboratory, ABH.

Managed analytical tests in raw material, finished products and stability samples; developed and validated analytical methods for drug products, vitamins A, D, E, K, and vitamin B’s; maintained and calibrated analytical R&D laboratory instruments and apparatus; wrote and reviewed SOPs, QC reports, validation protocols and validation reports; trained Ph.D. scientists in analytical tests and characterization with dosage forms of capsule, tablet, powder, and liquid.

2010 - 2011: Group leader, Frontage Laboratories

Lead method development and validation for API, new drug formulations; screened impurity profile for APIs from different vendors for pharmaceutical ANDA; performed Reverse Engineering testing on RLD of drug Products; prepared and reviewed analytical test method, method validation protocol, and method validation report; carried out formulation evaluation, release and stability tests; found chemical shifts and analyzed NMR spectroscopy for proposed molecular structure; provided technical guidance to lab staff and trained analytical scientists on new instruments and technologies.

2006-2010: Principal Scientist, Analytical Biochemistry Laboratories, Inc.

Directed development, validation and transfer of analytical methods for APIs, excipients, drug substances, drug products; stability tested and characterized drug products; purified and identified pharmaceutical unknowns in leachables, following FDA, ICH, and EPA guidelines; managed contract laboratories activities.

2005- 2006 Senior Chemist, Watson Pharmaceuticals, Inc.

Method validation and development for supporting APIs, drug formulations, and packaging development; quantitatively and qualitatively analyzed drug substance, drug products and control materials; performed drug release, stability tests and cleaning validation.

2004- 2005 Senior Chemist, Biodel Inc.

Developed and validated analytical methods for quantitative analysis of liquid dose drug formulation and metabolites in different biological matrix. These methods included chromatographic (RPC, SEC, IEC…), light scattering and other analytical methods; performed parenteral dosage forms and delivery systems analysis and routine bio-analytical testing for preclinical and clinical trials; identified drug impurities, studied hormone percentage load, and excipient concentrations; set acceptable criteria for parenteral drug IND; prepared analytical chemistry in (CMC) of the new drugs NDAs submission.

2001-2004 Senior Scientist, Formulations/analytical Research, MannKind Biopharmaceuticals.

Performed analytical tests for inhalation drugs; studied insulin conformational change during drug delivery; developed advanced bio-analytical techniques to characterize recombinant proteins; studied drug deliver molecules by NMR and other analytical methods, calculated and proposed delivery molecules structure.

Identified and quantified drug deliver molecule effects on drug products, and clinical impact.

Supervised multiple inhalation drug research projects: the study of the interaction between drug delivery system & insulin; the investigation of recombinant insulin delivery dynamics; the characterization of large molecule (parathyroid hormone) aggregation, oligomerization and hydrogen bonding by dynamic light scattering and other instrumentation; managed outsource radio-active isotope labeling C14 labeling and Insulin Tritium labeling and other activities.

1997-2001 Research Associate, Project leader, Bio-molecular Laser Research Center,

Studied wild-type and mutant hemoglobin and blood substitute. Analyzed bio-molecules structure & function by the advanced bio-molecule analytical working stations. (Raman, Near IR, Transient Absorption).

1992-1997 Research Assistant, Albert Einstein College of Medicine,

Designed, developed, and built three advanced bio-molecule analytical working stations (laser induced Raman, Near IR, Transient Absorption); characterized the structures of proteins, peptides, and small molecules. Studied macro-molecule structure related functions.

1990 - 1992 Teaching Assistant, Chemistry Dept. New York University

Taught the Honor Class; Set up a chemistry laboratory and two Raman analytical working stations; Studied protein ligand kinetic rebinding.

ANALYTICAL CHEMISTRY PROFICIENCY

Hand-on working experience with HPLC, GC, UPLC, Prep-HPLC, LC/MS, GC/MS, MS/TOF, LC/MS/MS and spectroscopic techniques of FTIR, NIR, Raman, ESR, fluorometer. Working expereince of Malvern Laser Dynamic Light Scattering particle sizer, Sympatec Sizer, DSC, Osmometer, polarimeter and other bio-molecular characterization and analysis techniques. Working experience in protein purification, protein structure & function analysis, pellet formulation, lyophilization.

HONORS

Certificate of “High Performance of Liquid Chromatography” from Waters, 13th March 2004.

Certificate of “Successful Preparative Liquid Chromatography” Waters, 13 th March 2003.

Certificate of “Successful Course Completion in Hazard Chemical Communication & Laboratory Safety Training” from Albert Einstein College of Medicine. Sept. 1998.

”Excellent Research Work” awarded by The Society of Chinese Bio-scientists in America 1994

Teaching Assistant to the Honor Class" Appointed by The Chemistry Dept. New York University, 1990

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