Expert Details
Pharmaceutical Manufacturing Processes, Quality Management, and FDA Interactions
ID: 733424
Pennsylvania, USA
Expert is a subject matter expert for the US FDA in Warning Latters and Consent Decree work and data Integrity issues. Expert provides cGMP support to the FDA and private industry in manufacturing quality of pharmaceuticals, vaccines, biologics and biotechnology drugs.
Quality management of warning Letters and lean system manufacturing
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1980 | Degree: PhD | Subject: Fermentation Technology / Biochemical Engineering / Chemistry | Institution: University of Manchester |
| Year: 1977 | Degree: MS | Subject: Fermentation Technology / Chemical Biosynthesis | Institution: University of Manchester |
| Year: 1976 | Degree: BS Hons | Subject: Chemistry | Institution: University of Leicester |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 1999 to Present | Employer: Undisclosed | Title: Managing Partner | Department: |
Responsibilities:Development of core expertise areas within company. |
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| Years | Employer | Title | Department |
| Years: 1994 to 2000 | Employer: Inflammatics | Title: CEO | Department: R&D |
Responsibilities:CEO of startup biotechnology company. Raised finance and directed production of material to cGMP. Planned clinical trials and selected clinical investigators. |
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| Years | Employer | Title | Department |
| Years: 1991 to 1994 | Employer: Sterling Winthrop | Title: Director | Department: Development |
Responsibilities:Steered production of biotechnology antibodies production and facility operations for clinical trials materials. |
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| Years | Employer | Title | Department |
| Years: 1989 to 1991 | Employer: SmithKline Beecham | Title: Development / Manufacturing | Department: Assistant Director |
Responsibilities:Directed start up of biomanufacturing plant for biopharmaceuticals . Project Director for facility bioreactors and processes. |
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| Years | Employer | Title | Department |
| Years: 1985 to 1989 | Employer: Allelix Inc | Title: Scale-up Manager, Pilot Plant | Department: Pilot Plant |
Responsibilities:Oversee all manufacture of materials for product targets and clinical materials from host production systems. |
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| Years | Employer | Title | Department |
| Years: 1979 to 1984 | Employer: Wolfson Institute of Biotechnology | Title: Pilot Plant Manager | Department: Pilot Plant |
Responsibilities:Development of industrial processes. |
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Government Experience
| Years | Agency | Role | Description |
|---|---|---|---|
| Years: 2011 to 2016 | Agency: USA FDA | Role: Quality SME consultant | Description: Quality systems, warning Letters Consent Decrees |
| Years: 2000 to 2002 | Agency: USA Department of Defense | Role: Consultant for bioterrorism programs | Description: Development of plans for manufacture of biological vaccines against threats -- example: Anthrax program. |
International Experience
| Years | Country / Region | Summary |
|---|---|---|
| Years: 1995 to Present | Country / Region: Global | Summary: Supplier of services in manufacturing and quality. |
Career Accomplishments
| Associations / Societies |
|---|
| Patents for bioreactors 1987 Patents for cell culture processes 1988/89 Entrepreneur Award 1995 ; best young talent, 1995 Commendation from Dept Defense for Anthrax vaccine production. 2002 |
| Licenses / Certifications |
|---|
| MRSC C.Chem 1988 MRSB C.Biol 2005 |
| Professional Appointments |
|---|
| Visiting guest lecturer in Biochemistry University McMaster Hamilton Ontario (1985-88). |
| Awards / Recognition |
|---|
| Commendation -- U.S. Department of Defense (2002) for Anthrax vaccine production. |
| Publications and Patents Summary |
|---|
| Expert has 20-30 paper and articles in the area of biological processes and equipment and manufacturing techniques. He has published a full-length book on lean manufacturing in the biological field. |