Uma Raul

Background

About Uma Raul

Experienced analytical scientist supporting of research and development and quality control for Biotech and Pharmaceutical companies in the USA, Canada and India. Expert in the development and validation of a wide range of analytical techniques. Specialized in chromatographic methods (LC and GC) and dissolution. Detail oriented and strong collaborator with experience in fast-paced, small as well as big company environments. Has authored analytical sections for IND and regulatory filings. Managed external testing at CRO/CMOs to ensure analytical activities meet internal timelines. Trained junior scientists on instrumentation, calculations and data processing. Technical Qualifications Extensive experience in Analytical method development, validation and transfer for small molecule drug substances and drug products. Expertise in chemical and physical analysis of Drug substances (DS), Drug products (DP) conforming to Pharmacopoeia (USP/NF, IP, BP, EP) and other non-compendial specifications. Hands on experience with HPLC /UPLC/Ion exchange Chromatography, LC-MS, Gas Chromatography (GC-HS, GC-FID), Spectrophotometers (UV/VIS, FTIR, Atomic Absorption), Dissolution apparatus I and II, KF (volumetric and coulometric, oven) Titrator, NMR, DSC, TGA and other routine instruments. Technical Skills Microsoft Office | ChemStation | Open Lab | Empower | Labware LIMS | JMP | Veeva | Master Control | FDA, ICH, USP guidelines | Biopharmaceutical classification system | GLP, GMP regulations.