Lois Dinterman
Product Quality Assurance Manager at Fhi 360
Based in Oxford, United States
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Seniority
Manager
Department
Other
Location
Oxford
Industry
International Trade and Development
Company size
8.4K
Contact information
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l•••••••@fhi360.org
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Background
About Lois Dinterman
Management of Cell Therapy Manufacturing projects • Quality Assurance reviewer and approver of manufacturing, testing, and engineering documents • Involved in preparation of CMC sections for several IND submissions and participated in meetings with FDA • Leader and mentor to engineering, validation, quality, R&D, manufacturing, and regulatory professionals • Played a key role in several successful cGMP manufacturing start-up operations • Over 10 years of experience associated with the development of validation strategies for equipment, facilities, and cGMP manufacturing • Highly skilled with the successful technology transfer from research and biotechnology/pharmaceutical industry into GMP and GLP environments • Mature professional with over 20 years of experience working in various roles within GMP environments Specialties: • Positive customer/client liasion and teamwork • Tech Transfer know-how • Selection and validation of equipment • GMP documentation • CMC sections of INDs • Biologics (vaccines, proteins, cell therapies)
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