Expert Details
Commissioning, Start-up and Validation of Biotechnology and Pharmaceutical Processes
ID: 730909
Texas, USA
Expert has formal training in microbial physiology, biochemistry and genetic mechanisms controlling the metabolism of microbial products. He has strong technical background and expertise in enzymology,
recombinant DNA technology and regulatory procedures, as well as design, construction, scale-up, start-up and operation of biotechnology and pharmaceutical manufacturing equipment and processes.
Expert's management experience includes profit/loss responsibility for an operating company, as well as project evaluation, selection and control of activities in U.S. and overseas operations.
Expert has consulted on production, purification and finishing facility for two injectable drug products (API’s: Epogen and Neupogen, produced via rDNA technology for treatment of disease. Expert has consulted on insulin projection.He has consulted on blending and packaging oral drugs. Expert is currently consulting on a pharmaceutical capsule product.
Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1976 | Degree: Ph.D. | Subject: Microbiology | Institution: Iowa State University |
| Year: 1973 | Degree: M.Sci. | Subject: Microbiology | Institution: Iowa State University |
| Year: 1969 | Degree: B.Sci. | Subject: Animal Science | Institution: Iowa State University |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2000 to Present | Employer: Undisclosed | Title: Principal | Department: Biotechnology/Pharmaceutical Consulting |
Responsibilities:He is a consultant to clients in the biotechnology, pharmaceutical and food industries. |
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| Years | Employer | Title | Department |
| Years: 2009 to Present | Employer: Undisclosed | Title: Adjunct Professor | Department: Biology |
Responsibilities:He taught courses and laboratories in Medical Microbiology and Biotechnology. |
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| Years | Employer | Title | Department |
| Years: 1994 to 2000 | Employer: (Undisclosed) | Title: Director | Department: Biotechnology/Pharmaceutical |
Responsibilities:Expert was a consulting specialist for internal engineering disciplines for biotechnology and pharmaceutical projects. |
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| Years | Employer | Title | Department |
| Years: 1988 to 1994 | Employer: (Undisclosed) | Title: Director of Validation Services | Department: Biotechnology/Pharmaceutical |
Responsibilities:Expert directed validation projects in pharmaceutical manufacturing operations for numerous drug manufacturers operations. |
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| Years | Employer | Title | Department |
| Years: 1982 to 1988 | Employer: (Undisclosed) | Title: Vice President R&D | Department: Research and Development |
Responsibilities:Expert was responsible for research, development, quality assurance, product and process validation, and regulatory affairs. |
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| Years | Employer | Title | Department |
| Years: 1976 to 1982 | Employer: (Undisclosed) | Title: Director | Department: Research and Development |
Responsibilities:Expert conducted project selection and funding for all corporate-sponsored R&D projects worldwide. |
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Fields of Expertise
applied biochemistry, applied microbiology, bacteriology, bacterium, biology, biotechnology, clinical microbiology, food processing good manufacturing practice, industrial fermentation, industrial microbiology, medical microbiology, microbial genetics, microbiological biomass fuel production, microbiological food vitamin analysis, microbiology, microbiology laboratory, molecular genetics, pharmaceutical drug, biotechnology management, DNA technology, enzyme technology, industrial biotechnology, streptococcus bacteria, water pollution microbiology, clean room microbiology, cheese microbiology, pharmaceutical liquid, microbiological broth, marine microbiology, gram-positive bacteria, food biotechnology, antimicrobial coating, biodegradation test, microbiological transport medium, bacteriophage, bacteriostatic agent, Helicobacter pylori bacterium, Bacillus subtilis, spirochete, Clostridium perfringens, bacterial vaccine, citrate, biohazard management, clinical laboratory regulation, agar, sulfur bacterium, 40 CFR Part 160 FIFRA Final Rule, injectable pharmaceutical product, bacterial inhibition, bacterial spore, antibacterial soap, air microbial contamination, biological control, mycoplasma, Legionella pneumophila, applied molecular biology, actinomycete, botulism, bio-clean room, biomass, dairy microbiology, enterobacterium, Vibrio cholerae, salmonella, plant biotechnology, nutrition, mycobacterium, genetics, bacterial endotoxin, ecology, culture maintenance, cottage cheese, Chlamydia bacterium, biochemistry, bacterial plasmid, bacterial culture, antigen, alcoholic beverage