Expert Details
Pharmaceutical Product Development, Dosage Forms, Controlled Release, QC/QA, GMP, China
ID: 729777
Oklahoma, USA
Expert has lived in China for 7 years, has traveled extensively throughout Asia, and has a good command of Mandarin Chinese. Expert has managed development, manufacturing, and analytical testing projects in China, while based in the US. Expert has consulted for US pharmaceutical firms in China.
Education
Year | Degree | Subject | Institution |
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Year: 1990 | Degree: PhD | Subject: Chemistry | Institution: University of Southern California |
Year: 1984 | Degree: BS | Subject: Chemistry | Institution: University of Oklahoma |
Work History
Years | Employer | Title | Department |
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Years: 2019 to Present | Employer: Undisclosed | Title: QA Auditor | Department: |
Responsibilities:Available upon request. |
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Years | Employer | Title | Department |
Years: 2019 to Present | Employer: Undisclosed | Title: Independent Consultant, Pharmaceuticals | Department: |
Responsibilities:Available upon request. |
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Years | Employer | Title | Department |
Years: 2019 to 2019 | Employer: HBT Labs Inc. | Title: VP Manufacturing Operations | Department: |
Responsibilities:Available upon request. |
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Years | Employer | Title | Department |
Years: 2018 to 2018 | Employer: Hefei NoraTech Pharmaceuticals, Ltd. | Title: Executive Vice President | Department: |
Responsibilities:Hefei, Anhui, China |
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Years | Employer | Title | Department |
Years: 2015 to 2018 | Employer: ChemWerth Inc. | Title: Compliance and Project Management Senior Specialist | Department: |
Responsibilities:Responsible for GMP compliance of Chinese API factoriesTrouble shooting of technical issues related to API production Helping to set up and strengthen quality departments in factories |
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Years | Employer | Title | Department |
Years: 2014 to 2015 | Employer: Frontage Laboratories, Inc. | Title: VP, Quality | Department: |
Responsibilities:Available upon request. |
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Years | Employer | Title | Department |
Years: 2008 to 2014 | Employer: Altheus Therapeutics | Title: Vice President | Department: Product Development |
Responsibilities:Expert is responsible for all aspects of product development, manufacturing, and quality control/assurance. |
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Years | Employer | Title | Department |
Years: 2005 to 2008 | Employer: CTNS | Title: Program Director | Department: Inter-disciplinary Research |
Responsibilities:Directed an inter-disciplinary, international grant-making program in the area of science and transcendence. |
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Years | Employer | Title | Department |
Years: 2001 to 2005 | Employer: Self Employed | Title: President and CEO | Department: International Consulting |
Responsibilities:Provided consulting and training services to Chinese companies and individuals. |
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Years | Employer | Title | Department |
Years: 1992 to 1997 | Employer: Nexstar (now Gilead Sciences) | Title: Director of Product and Process Characterization | Department: Product Development |
Responsibilities:Managed team of 21 scientists and lab technicians; responsible for all raw materials, in-process, and final product characterization. |
Government Experience
Years | Agency | Role | Description |
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Years: 1990 to 1992 | Agency: NIST | Role: Research scientist | Description: Was awarded a National Science Foundation research fellowship; conducted research on polymer blends at NIST for 2 years. |
International Experience
Years | Country / Region | Summary |
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Years: 2008 to Present | Country / Region: Shanghai, China | Summary: Expert is managing a contract manufacturing project with a Chinese company in Shanghai, China. The project includes two dosage forms, formulation development, and extensive analytical characterization. |
Years: 2001 to 2004 | Country / Region: Beijing, China | Summary: Provided technical and professional guidance for professors at the Chinese Academy of Sciences, Chemistry Institute in Beijing, China. |
Years: 1997 to 2009 | Country / Region: Asia | Summary: Expert lived in China for 7 years, and has traveled extensively in Asia, doing business consulting and training. Experience in China, Hong Kong, Taiwan, Singapore, Thailand, Korea, Japan, India, Philippines, and Indonesia. |
Years: 2007 to 2007 | Country / Region: Cancun, Mexico | Summary: Expert coordinated a series of research conferences aimed at forming teams of inter-disciplinary researchers for the purpose of grant making. |
Years: 2005 to 2008 | Country / Region: Asia and Europe | Summary: As program director of an innovative grant-making project, expert collaborated with researchers from the US, Asia, and Europe. |
Additional Experience
Training / Seminars |
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He has training and experience in cGMP; he has also conducted training in this area. |
Other Relevant Experience |
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Competent in Mandarin Chinese. |
Language Skills
Language | Proficiency |
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Mandarin Chinese | Competent in spoken Mandarin Chinese; can read street signs and other simple characters. |
Fields of Expertise
analytical method validation, controlled-release oral drug delivery, Current Good Manufacturing Practice, drug formulation, drug stability, pharmaceutical manufacturing, pharmaceutical product development, pharmaceutical product shelf life testing, pharmaceutical quality assurance, pharmaceutical quality control, pharmaceutical research and development, pharmaceutical scale-up, China contract manufacturing, enteric-coated tablet, manufacturing quality control, active pharmaceutical ingredient, Good Manufacturing Practice training, pre-approval inspection, outsourcing, Food and Drug Administration validation, pharmaceutical manufacturing facility auditing, injectable pharmaceutical product, pharmaceutical product formulation, solid pharmaceutical product, topical drug, drug development, pharmaceutical industry, Food and Drug Administration drug packaging regulation, pharmaceutical inventory management, validation, drug dosage form development, international manufacturing, controlled-release drug delivery, Food and Drug Administration regulation, drug regulation, gastrointestinal drug, drug screening, dosage form