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