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.

📌 Associate Scientist - ADL (Pune)
🏢 LUPIN
📍 Pune