Scientist
CurrentExpertise: Using DOE Quality by Design (QbD) principles to rapidly develop robust HPLC analyitcal methods (Purity HPLCs) for mAb, peptiboides and protein-drug conjugates. Experienced user of Fusion QbD software for Liquid chromatography (LC) Method Development, Robustness Evaluation and Method Qualfiiadtion for large protein molecules. Experiences:Yellow Belt in Lean Six Sigma Process ControlsOver 11 years experience in analytical method development and optimizaton. Method qualifiation/validation, and method transfer activities to GLP and QC Groups. Lead in Analytical Platforms : Method Robustness and Method Qualification/Validation. Contribute to IND section for FDA filings.Extensive hands on experiences with various analyticall methods: SEC-HPLC, RP-HPLC, IEX-HPLC, Pro A titer, CIEF, Peptide map and Glycan map analysis. Protein characterization assays to monitor post-translational modifications.Publication:Co-author: ACS Books "Biopharmaceutical Charactierzation", Chapter 12. Separation Methods and Orthogonal Techniques. March 2015.