Rajesh Reddem

Background

About Rajesh Reddem

Being a scientist, I have expertise in QBD based HPLC Analytical method development for both drug substance and drug product by utilization of software tools(Fusion QbD, ACD labs Autochrome, ChromSword.) to model experimental design space in order to identify a robust operating region. I detect consequential knowledge gaps, formulate comprehensive research strategies, and then execute rigorous methodological and analytical steps. A diversified professional who has the capability to “Think Backwards” and “Out Of the Box” with a splendid communal and representing skills. Have the ability to set targets and work backwards. Proven track record of Insisting on high standards with an exposure of versatile analytical skills and Earn Trust of peer group. Development of stability indicating analytical methods for assay, and related substances for Drug substance and finished dosage forms by HPLC by application of ACD labs software (Autochrome) and QbD software S-Matrix Handled different types of pharmaceutical dosage forms Solid oral (tablets and capsules), Parentrals (LIVI), Topicals (Creams, ointments and gels), Lyophilisate in vial and suspensions. Responsible to perform stability studies (GLP tox-stability, Technical stability, Clinical stability and registration stability) for NCE molecules (both for drug substance and drug product) as per the protocol. Preparation of method validation protocols for Assay, Related substances, residue, residual solvents as per the SOP and execution. To carry out laboratory investigations like OOS (Out Of Specification), OOE (Out Of Expectation) Specialization: HPLC method development, LCMS, Dissolution method development2DLC, Preparative.