Wael Elmasri
Manager, Ms, Phrmaceutical Development Services @Thermo Fisher Scientific
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WORK HISTORY
Manager, Ms, Phrmaceutical Development Services @Thermo Fisher Scientific
Greenville, NC, US
Lead of a team of formulation, analytical and manufacturing experts Responsible for technology transfer activities, GMP/clinical, and PPQ runs. Leadership and support to manufacturing activities including data trending, sophisticated deviation investigation, risk mitigations and continuous improvements. Optimization and coordination of the process related activities through cross-functional partnership for start-up and new product introduction. Supports CMC/regulatory filing documentation. Aligns department activities with other internal and external team members. Support mass spectrometry activities
EDUCATION
National Association Board of Pharmacy, USA
FPGEE
University of North Carolina Wilmington
Master of Business Administration - MBA
Texas Tech University
Doctor of Philosophy (PhD)
Mansoura University
Bachelor of Pharmacy (B.Pharm.)
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.
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