Associate Scientist - ADL

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. .