Wael Elmasri

Background

About Wael Elmasri

I help patients through development of new medications from clinical phases to commercial. I use my expertise in formulation, development, transfer and validation of analytical methods and FDA guidelines, setting specifications for impurities and in- process, release and stability testing. I lead Nitrosamines MD,MV and analysis besides impurities characterization applying mass spectrometry and nuclear magnetic resonance. I design and perform photo-stability, leachables, extractables, and stress studies. I coordinate internal/external scientific, analytical, and laboratory functional areas to meet project and team objectives. I perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines. I am SME for HPLC,GCMS, LCMS,ICPMS, FTIR, UV/vis and NMR; l use these techniques to develop QbD stability indicating methods and characterise impurities to help Pharma companies launching their products to market. I am a project leader for small molecules and biologicals. I am a mentor, chemist, pharmacist, and manager, with 24 years of analytical chemistry and pharmaceutical science expertise. I am authentic with high level of integrity, good communication, collaboration and team building skills. I am expert in empower, chromeleon, Chemstation, MassHunter, Qtegra, Masslynx, and Xcalibur. Author, Editor and Reviewer of scientific articles. Author SOPs for cGMP environment. In addition, I use Microsoft Project to set timeline for projects, and Minitab for statistical analysis to support analytical validation and stability. I have project managment, leadership, people management skills besides SAS and SSGB. I help with on boarding instruments, choosing the right system(Mass Spec, LC, …etc), adding the right detection parameters and compare prices, execute Qualification protocols for instruments(OQ/PQ, ….), authoring system SOPs, maintaining and troubleshooting, and creating effective training curricula.