Sr. Chemist (Method Development)

Role & responsibilities

• 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.
• Strong analytical, documentation, and troubleshooting skills.