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SUMMARY OF EXPERTISE:
- 19+ Years Experience in the Pharmaceutical and Biotechnology Fields
- 10+ Years Experience in Quality Assurance; 5+ Years at Director Levels
- Experience in Small Molecule APIs, Solid Oral Dosage Forms, Live Virus Vaccines
- Multinational Experience with Contract Organizations/Partners in Europe, Canada, and Japan
- Experience in Validation (Facility, Process, QC Test Methods, Shipping)
- Regulatory Experience in IND, NDA, ANDA, and BLA filings, Inspections, etc.
EDUCATION:
| Ph.D. |
Philosophy, Chemistry, University of California (1990) |
| M.S |
Chemistry, Western Washington University (1983) |
| B.A |
Chemistry, Western Washington University (1981) |
EXPERIENCE:
CURRENT
POSITION 2008 to present: |
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Sr. Consultant , BCG-Japan,
Tokyo, Japan
- Provide advice in the areas of pharmaceutical and biotechnology, quality assurance, quality control , manufacturing, CMC, development, and validation
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| Aug. 2005 – present |
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Independent Consultant, Pacifica, CA / Kumamoto, Japan
- Provide advice in the areas of pharmaceutical and biotechnology, quality assurance, quality control , manufacturing, CMC, development, and validation
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| Nov. 2002 – Aug. 2005 |
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Director of Quality Assurance, VaxGen, Inc., Brisbane, CA .
- Responsible for all QA activities
- Quality Team Leader for LC16m8 Smallpox Vaccine Project
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| Aug. 2002 – Nov. 2002 |
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Director of Quality, Genelabs Technologies, Inc., Redwood City, CA. |
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| Mar. 2000 – Aug. 2002 |
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Associate Director of Quality, Genelabs Technologies, Inc., Redwood City, CA. |
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| Jul. 1999 – Mar. 2000 |
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Manager of Quality Assurance, Pharmacyclics, Inc., Sunnyvale, CA.
- Injectable Therapeutics - Responsible for all API QA activities
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| Mar. 1996 – Jul. 1999 |
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Quality Assurance Specialist, Gilead Sciences, Inc., Foster City, CA.
- Oral, Topical, and Injectable Therapeutics - Responsible for all API QA activities
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| Jul. 1995 – Mar. 1996 |
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Sr. Chemistry Specialist, Aerojet, Rancho Cordova, CA.
- Custom APIs and Fine Chemicals - Responsible for custom API process development projects and establishing cGMP systems
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| May 1990 – May 1994 |
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Process Development Chemist, Abbott Laboratories, North Chicago, IL.
- Custom and Generic APIs - Responsible for custom and generic API process development
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| Feb. 1986 – Feb. 1987 |
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Research Scientist, Schering-Plough, Inc., Bloomfield (now Kenilworth), NJ.
- Antifungal/Antiviral Medicinal Chemistry - Synthesis of medicinally active compounds
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| Jul. 1985 – Jan. 1986 |
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Development Chemist, Biophysica Foundation, La Jolla, CA.
- Radiocontrast Imaging Agents - Process Development of novel imaging agent
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PROFESSIONAL ORGANIZATIONS:
PDA
Sigma Xi
American Association for the Advancement of Science (AAAS)
American Chemical Society (ACS)
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PUBLICATIONS AND SEMINARS |
| Oct. 2005 |
Professional Instructor, IBC-ASIA, Singapore, Process Validation Course (2 Day) |
| Jun. 2002 |
Professional Instructor, IVT, Dublin, Ireland, Process Validation Course (1 Day) |
| 2002 |
R.W. Koops, Journal of Validation Technology, No. 2, p. 102. Process Validation of Synthetic Chemical Processes for the Production of Active Pharmaceutical Ingredients (APIs) |
| 1998 |
Deshpande, Cain, Patel, Singam, Brown, Gupta, Barkalow, Callen, Patel, Koops, Chorghade, Foote, Pariza, Organic Process Research and Development, No. 2, p. 351. |
| 1995 |
Bhatia, Chamberlin, Davis, Hayes, Klix, Koops, Rojas, Tetrahedron Letters, No. 36, p. 1791. |
| 1992 |
Midland, Koops, Journal of Organic Chemistry, No. 57, p. 1158. |
| 1990 |
Midland, Koops, Journal of Organic Chemistry, No. 55, p. 5058. |
| 1990 |
Koops, Doctoral Dissertation, University of California, Riverside. |
| 1990 |
Midland, Koops, Journal of Organic Chemistry, No. 55, p. 4647. |
| 1987 |
Gupta, Johnson, Lampman, Koops, Journal of Organometallic Chemistry, No. 326, p. 281. |
| 1985 |
Olden, Lampman, Koops, Journal of Chemical Education, No. 62, p. 267. |
| 1983 |
Koops, Master’s Thesis, Western Washington University |
Page
Updated:
April 2, 2009
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