AdaMae Lewis, PhD

SUMMARY OF QUALIFICATIONS
    ☐ 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.
    ☐ Communication - Interpret and present complex technical information in simplified concepts.
    ☐ Organization/Administration - Professional and volunteer experience organizing, managing and
    supervising employees/volunteers in the accomplishment of organizational objectives.
    ☐ Interpersonal Relations - Skil ed in working with a diverse base of co-workers, employees,
    supervisors, client groups, including international students, and foreign nationals in the U.S.A.
    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).
    ☐ 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.
PROFESSIONAL EXPERIENCE
2007-present, President/Co-owner Consultants for Veterinary Biologics, LLC. Continue consulting
with expanded services offering for clients.
1994-present. President/Owner Lewis Biologics Consulting, Inc. Including facilitating Veterinary
Biologics Training Program for OIE/Institute for International Cooperation in Animal Biologics 1996-2014.
1994. Team Leader, Product Inspection, USDA, Veterinary Biologics Field Operations (VBFO)
currently Inspection and Compliance, Ames, Iowa. Formulated, organized, control ed and executed a
National program for the inspection and release of veterinary biologics. Included duties of Senior
Biologics Specialist (See below, 1989-1994).
1989-1994. Microbiologist/Senior Biologics Specialist, VBFO 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).
1987-1989. Microbiologist/Biologics Specialist, VBFO 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.
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