Bao-Shan Huang, Ph.D.
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. |
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| 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 |
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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. |
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| 1979 - 1993 | Chairman GI Drug Discovery | Ohmeda |
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| 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 |
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Associate researcher synthesizing heterocyclics and imidazoles of interest as metabolites for chemotherapy agents |
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Education
| 1975 | Ph.D., Organic Chemistry |
Mississippi State University |
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| 1983 | M.Sc., Organic Chemistry | Northwestern State University of Louisiana |
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| 1974 | B.Sc. Agricultural Chemistry and Food Science |
National Taiwan Chung-Hsing University |
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