Dr. Esmaeil Ektefaie, Sr. is based in Takeda Company in Vienna and has been with the company for 24 years. His professional background is in Chemical Engineering. He obtained BS, MS, and PhD degrees at Technical University of Vienna and got a degree in Biotechnology. He started to work in the validation department and worked his way up to quality validation specialist.
He has held lectures in PAT Quality by Design and Process Improvement, PDA/EMEA Joint Conference Cleaning Validation, Genotoxic Impurities, Impurities, Cleaning Validation, Designing a cleaning and disinfection program for a GMP manufacturing Environment, Pharmaceutical Analysis.
In his role he is responsible for regulatory and GXP requirement for validations.
The exponential increase in demand to manufacture therapeutics including vaccines triggered by the pandemic has stressed the supply chain for single-use products.