Officer/ Sr Officer R&D ADL

Role & responsibilities

• Strong practical knowledge of HPLC method development and validation for assay and related substances of Active Pharmaceutical Ingredients/Formulations.
• Experience in characterization of drug substances, including intermediates, in-process materials, stability samples, and unknown impurities (identification/confirmation).
• Preparation and review of SOPs, STPs, and specifications.
• Hands-on experience with analytical instruments such as Gas Chromatography (GC), UV Spectrophotometer, Auto Titrator, Karl Fischer, etc.
• Knowledge of ion chromatography for analysis of ionic impurities in drug substances.
• Preparation of technical documents and reports, including AMDR, protocols, justification reports, and analytical reports.
• Ensure adherence to GMP, SOPs, and EHS (Environment, Health & Safety) regulations.