Process Development Researcher
Assessing feasibility and validating methodologies for testing potency of post-early development molecules within the Analytical Development Quality Control Department under Good Manufacturing Practices (GMP).Developed and parameterized an ELISA for testing Drug Substance component potency, authored TP for GMP method guidance and demonstrated equipment suitability for automated assay runtime.Generated and documented key experiments for tracking the development steps taken to be cited and used for Phase 1 Pre-clinical potency of the molecule in questionCell Banked cell lines for Potency assay development and SOP generation pertaining to cell line qualification and maintenance as well as molecular potency in a heavily regulated GMP environmentGenerated and debugged a Reporter Gene Cell-based Assay testing the formulation Mechanism of Action on the maintained cell line.Simultaneously demonstrated and developed on a different TP undergoing validation for Equipment and Reagent suitability for sustainability through an untested automation equipment and a serum free cell media.