Associate Scientist - ADL

Job description

Role & responsibilities Analytical Method Development & Validation • Develop, optimize, and validate analytical methods using HPLC, UPLC, LC-MS/MS, and HRMS. • Establish stability-indicating methods for assay, related substances, impurities, residual solvents, and dissolution testing. • Perform method verification, method transfer, and troubleshooting activities. • Support analytical method lifecycle management in accordance with ICH guidelines. Forced Degradation & Stability Studies • Design and execute forced degradation studies under acid, alkali, oxidative, thermal, photolytic, and humidity stress conditions. • Evaluate degradation pathways and characterize degradation products using LC-MS and HRMS. • Generate degradation profiles and demonstrate method specificity. • Support stability studies and stability-indicating method development. Mass Balance & Impurity Characterization • Perform mass balance evaluations for APIs and intermediates. • Investigate unknown impurities and degradation products. • Conduct impurity profiling and characterization using advanced analytical techniques. • Interpret mass spectral data and propose structures for unknown compounds. • Collaborate with Process R&D and Synthesis teams for impurity tracking and root cause investigations. Documentation & Regulatory Support • Prepare method development reports, validation protocols/reports, forced degradation reports, mass balance reports, and investigation reports. • Maintain accurate laboratory notebooks and analytical records in compliance with cGMP and Data Integrity requirements. • Support regulatory submissions and responses to customer/regulatory queries. Instrument Operation & Compliance • Operate and maintain HPLC/UPLC, LC-MS/MS, HRMS, UV Spectrophotometers, and Dissolution Systems. • Ensure proper calibration, qualification, and maintenance of analytical instruments. • Follow ICH, USP, EP, IP, GLP, cGMP, and internal SOP requirements.