Your Course Leader
Dr. Menendez is currently an international instructor and consultant on GMP/GLP/GCLP Bioassay Method Development and Validation. In her previous position as Senior Director of Biotechnology at Catalent Pharma Solutions she implemented various laboratories to verify the functionality and safety of biotechnology products using cellular, molecular and immunological technologies. Her expertise covers potency, PK and immunogenicity testing. Her latest industry paper provides recommendations for preparing and storing non-manufacturing cell banks used in GMP/GLP and GCLP analysis.
Dr. Menendez joined Catalent in 2001 from Bristol-Myers Squibb, where as Associate Director of Regulatory Sciences she transitioned Oncology and Infectious Diseases candidates from the lab bench to the clinic. Dr. Menendez obtained her Ph.D. in Microbiology/Immunology and she pioneered monoclonal antibody technology at Wyeth from 1982 to 1995.
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