Bao-Shan Huang, Ph.D.

Bao-Sah Huang

Process Development, Analytical Laboratory Control Specialist

 

Bao-Shan Huang is a Native of China, Speaks fluent Chinese

 

 

Bao-Shan Huang, Ph.D. - Process Development, Analytical Laboratory Control Specialist

Qualifications

Over thirty years experience in drug substance development, drug substance manufacture, quality control and quality assurance functions. Highly motivated. Native Chinese speaker.

Work History

2008 - Present
Senior Consultant - Process Development, Analytical Laboratory Control Specialist
D.H Gold Associates, Inc.
    Expertise in quality control and quality assurance requirements.  Highly experienced with preparation for and management of FDA inspections.
1994 - 2008 Director of Quality and R&D
Penick Corporation
   
Directed the firm’s quality assurance activities, quality control laboratories and  research and development program for new, more cost-effective routes to the manufacture of narcotics. Inventor of seven U.S. and Foreign patents covering Penick’s core products.  Directed the qualification of equipment, the validation of reaction processes, fermentation processes and purified water systems.  Established a fully compliant SOP program, meeting all FDA and DEA requirements. Point person at biennial FDA inspections and periodic DEA inspections.
1979 - 1993 Chairman GI Drug Discovery
Ohmeda
    Increasingly responsible research development positions culminating in Chairmanship of the GI Drug Discovery Team.  Inventor of three patents for products of interest to Ohmeda.
1973 - 1979 Research Associate
Sloan Kettering
   

Associate researcher synthesizing heterocyclics and imidazoles of interest as metabolites for chemotherapy agents

Education

  1975

Ph.D., Organic Chemistry

Mississippi State University
  1983 M.Sc., Organic Chemistry
Northwestern State University of Louisiana
  1974

B.Sc. Agricultural Chemistry and Food Science

National Taiwan Chung-Hsing University

 

 

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D.H.Gold Associates, Inc. - Consultants

D.H.Gold Associates, Inc. has assembled well skilled professionals to complement Dr. Gold’s background.  Detailed CV’s of each associates are available by following the links below:

 

Daniel H. Gold, Ph.D. - President & CEO

Stanley Alekman, Ph.D. - Analytical Chemistry & Statistics Specialist

William Bennett, M.S., B.S. - Engineering & Manufacturing Specialist

Bao-Shan Huang, Ph.D. - Process Development, Analytical Laboratory Control Specialist

Jeanne Moldenhauer, M.S. - Microbiology Specialist

Eugene Rynkowski, M.S. - Analytical Chemistry Specialist

Eric Sheinin, Ph.D. - Specialist in CMC Sections of NDA, ANDA & DMF Filings

James Shaver, B.S., B.Ch.E - Engineering & Operational Management Specialist

Bernd Dölle, Ph.D. - Aseptic Manufacturing, PDA/FDA Barrier Technology Specialist

Takeo Murakawa, Ph.D. - Drug Development & Regulatory Affairs Specialist

Thomas Murphy, M.S. - Industrial Statistical Consultant

 

DHG Consulting Team with a total of 195+ years in the Pharmaceutical Industry.

 

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