- Develop, optimize, and validate HPLC analytical methods for assay, related substances, dissolution, and impurity profiling.
- Select appropriate chromatographic conditions including columns, mobile phases, buffers, gradient programs, and detection wavelengths.
- Conduct method robustness, specificity, accuracy, precision, linearity, range, and sensitivity studies as per ICH guidelines.
- Troubleshoot chromatographic issues and ensure system suitability compliance.
- Maintain laboratory notebooks, analytical records, and electronic data integrity as per ALCOA+ principles.
- Ensure timely execution of analytical activities and accurate reporting of results.
Preferred candidate profile
- Hands-on experience in HPLC method development.
- Knowledge of ICH guidelines and pharmaceutical analytical techniques.
- Experience with Empower, Chromeleon, or similar chromatography software.
- Solid analytical, documentation, and troubleshooting skills.