Role & responsibilities

Analytical Method Development & Validation
- Develop, optimize, and validate analytical methods for APIs, intermediates, raw materials, and in-process samples.
- Perform analytical method development and validation using HPLC, UPLC, GC, LC-MS/MS, UV and related analytical techniques.
- Execute assay, related substances, and residual solvent method validations as per ICH guidelines.
- Prepare validation protocols, reports, and regulatory documentation.
- Support analytical troubleshooting, method transfer, and technology transfer activities.

Impurity Profiling & Characterization
- Conduct forced degradation studies and evaluate degradation pathways.
- Perform impurity profiling, identification, and characterization of unknown impurities.
- Investigate degradation products generated during synthesis, stability, and stress studies.
- Utilize LC-MS/MS and advanced analytical techniques for impurity characterization and root cause investigations.
- Support impurity assessments for regulatory submissions.

Structure Elucidation & Spectroscopic Analysis




- Interpret and elucidate chemical structures using NMR, Mass Spectrometry, FTIR, and UV spectroscopy.
- Analyze and interpret:
- 1H NMR
- 13C NMR
- DEPT
- COSY
- HSQC
- HMBC
- NOESY
- Perform structural confirmation of APIs, intermediates, impurities, and reference standards.
- Prepare characterization reports and scientific documentation.

Instrument Management
- Operate, troubleshoot, maintain, and calibrate analytical instruments including:
- HPLC / UPLC
- GC
- LC-MS/MS
- NMR
- FTIR
- UV-Visible Spectrophotometers
- Ensure compliance with calibration schedules, SOPs, data integrity, and laboratory best practices.

Team Leadership & Project Management
- Lead, mentor, and develop a team of analytical scientists.
- Plan and monitor analytical projects and resource allocation.
- Review analytical data, laboratory records, protocols, and reports.
- Provide technical guidance and scientific leadershi

📌 Research Scientist (Pune)
🏢 Lupin Manufacturing Solutions Limited (LMSL)
📍 Pune