Research Scientist

Pharmaceutical Ingredient (API), intermediates, impurities, starting material and excipients from drug substances and drug products. Analyze organic and inorganic compounds to determine chemical or physical properties, composition, structure, relationships, reactions, using chromatography, spectroscopy, spectrophotometry techniques including HPLC, UPLC, IC, GC, MS, UV, XRPD, DSC, TGA, NMR, and KF. Design and perform method verification and validation. Determine the specificity, linearity, accuracy, precision, forced degradation, robustness of the methods. Collect and analyze data, and maintain data integrity under GMP, GLP, and FDA regulations. Prepare documentation of test procedures and technical reports. Prepare, review, and/or approve methods, protocols, and development reports. Maintain laboratory instruments to ensure proper working order. Apply scientific expertise to troubleshooting, laboratory investigation and problem resolution. Participate in maintaining high quality laboratory environment and comply with Health, Safety and Environmental responsibilities for the position.