Ali Sadeghi-Khomami Email & Phone Number

Design and Formulation of In-Vitro Diagnostic Assays in the field of Hemostasis and Coagulation according to US FDA’s regulations for Medical Devices (21 CFR-820), ISO 13485, CLSI guidelines and Quality System Regulation (QSR) using Project Management Institute (PMI) best practices, tools and techniques.>> Hemostasis and Coagulation: IVD, FDA 510k application, Design Control, DHF, DMR, Verification/Validation, cGMP, QSR and CAPA >> Bio-Organic Chemistry: especially in the field of Carbohydrate, Nucleotide, Peptide and Phospholipid Compounds; Solid Phase Synthesis; Isolation and Identification of Active Components from Natural Products; Protein-Ligand Interaction Studies>> Molecular Biology: Protein over-expression and Purification>> Enzymology: Enzyme engineering by site directed mutagenesis and directed evolution mutagenesis; Design and synthesis of enzyme mechanistic probes; Enzyme characterization; Enzymatic assays; ELISA>> Computer Aided Drug Design (CADD): Molecular modelling and virtual screening of chemical libraries

Listed skills include Protein Chemistry, Molecular Biology, Purification, Protein Expression, and 31 others.