ADAMAE LEWIS, PhD
Founder
SUMMARY OF QUALIFICATIONS
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Regulatory Affairs - Over 25 years of practical experience, extensive knowledge of federal policy, regulations and the Virus-Serum-Toxin Act. Identify areas of non-compliance by veterinary biologics manufacturers, recommend changes and corrective action plans
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Communication - Interpret and present complex technical information in simplified concepts
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Organization/Administration - Professional and volunteer experience organizing, managing and supervising employees/volunteers in the accomplishment of organizational objectives
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Interpersonal Relations - Skilled in working with a diverse base of co-workers, employees, supervisors, client groups, including international students, and foreign nationals in the USA and abroad. Experienced speaking to small and large groups. Extensive networking within the United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS)
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International Experience - Taught postgraduate students Integrated Pest Management at UNAN, León, Nicaragua, for Smithsonian Environmental Program/Peace Corps. Considerable international volunteer work and directing international Boards of Directors
EDUCATION
Doctor of Philosophy, Iowa State University, Ames, Iowa
Major: Microbiology
Master of Science, South Dakota State University, Brookings, South Dakota
Major: Entomology and Microbiology
Bachelor of Science, South Dakota State University, Brookings, South Dakota,
Major: Zoology and Entomology
WORK EXPERIENCE
2008 - Present
1996 - Present
1994
1989 - 1994
1987 - 1989
Consultants for Veterinary Biologics, LLC
President/Co-owner
Continue consulting with expanded services offering for clients
Lewis Biologics Consulting, Inc.
President/Owner
Including facilitating Veterinary Biologics Training Program for OIE/Institute for International Cooperation in Animal Biologics 1996-2014
USDA, Veterinary Biologics Field Operations (VBFO) currently Inspection and Compliance, Ames, IA
Team Leader, Product Inspection,
Formulated, organized, controlled and executed a National program for the inspection and release of veterinary biologics. Included duties of Senior Biologics Specialist (See below, 1989-1994)
VBFO
Microbiologist/Senior Biologics Specialist
Interacted with foreign manufacturers, worked one-on-one with designated liaison of permittees, trained Biologics Specialists, foreign and
government personnel about USA biologics industries, regulations and policies. Monitored and evaluated employee job performance. Prepared regulatory reports and management documents. Acted for the Director of VBFO in his absence. Directed investigations of suspected violations of the Virus-Serum-Toxin Act. Interviewed candidates for Biologics Specialist positions. Prepared and conducted special technical and management projects. Included duties of Biologics Specialist (See below, 1987-1989)
VBFO
Microbiologist/Biologics Specialist
Responsibility for 20 licensed veterinary biologics manufacturers to assure compliance with the Virus-Serum-Toxin Act. Responded to licensee's
requests. Reviewed licensee's serial testing for suitability of release. Responded to consumer reports regarding product inquiry and failure. Educated licensees through inspection, working one-on-one with
designated liaison, and at public meetings. Conducted inspections, developed recommendations to comply with regulations, presented findings to company officials, and wrote reports of inspection findings.