- Solid 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.