Intellex Acquires Expert by Big Village

We're thrilled to announce that Intellex has acquired Expert by Big Village, effective March 22, 2024. This strategic move enhances our capabilities and strengthens our commitment to delivering exceptional solutions to our customers.

Stay tuned for more updates on how this acquisition will benefit our clients and experts.

For inquiries or more information, please contact us at info@intellex.com.

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Expert Details

Pharmaceutical Product Development, Dosage Forms, Controlled Release, QC/QA, GMP, China

ID: 729777 Oklahoma, USA

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Expert has worked in the pharmaceutical industry as a research scientist, QC/QA director, vice president of product development, and has been involved in product development from pre-clinical through Phase 1 production. Expert has experience in setting up a cGMP manufacturing facility, with accompanying quality systems in place. Expert has worked on parenterals, topicals, and oral dosage forms, and has developed controlled release oral systems.

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
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
Years: 2019 to Present Employer: Undisclosed Title: QA Auditor Department:
Responsibilities:
Available upon request.
Years Employer Title Department
Years: 2019 to Present Employer: Undisclosed Title: Independent Consultant, Pharmaceuticals Department:
Responsibilities:
Available upon request.
Years Employer Title Department
Years: 2019 to 2019 Employer: HBT Labs Inc. Title: VP Manufacturing Operations Department:
Responsibilities:
Available upon request.
Years Employer Title Department
Years: 2018 to 2018 Employer: Hefei NoraTech Pharmaceuticals, Ltd. Title: Executive Vice President Department:
Responsibilities:
Hefei, Anhui, China
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 factories
Trouble shooting of technical issues related to API production
Helping to set up and strengthen quality departments in factories
Years Employer Title Department
Years: 2014 to 2015 Employer: Frontage Laboratories, Inc. Title: VP, Quality Department:
Responsibilities:
Available upon request.
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.
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.
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.
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
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
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
He has training and experience in cGMP; he has also conducted training in this area.
Other Relevant Experience
Competent in Mandarin Chinese.

Language Skills

Language Proficiency
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

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