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 leadership to project teams.
- Collaborate with R&D;, QA, Regulatory Affairs, Manufacturing, and Procurement teams.

Regulatory & Vendor Coordination

- Coordinate with vendors for impurity standards, solvents, reference standards, and raw materials.
- Support qualification and characterization of analytical reference standards.
- Prepare technical justifications and regulatory documentation.
- Participate in customer audits, regulatory inspections, and quality audits.

Reporting & Communication

- Prepare and present project updates, technical reviews, and management reports.
- Track project milestones, risks, action plans, and deliverables.
- Communicate analytical findings effectively to internal and external stakeholders.

Compliance & Documentation

- Maintain laboratory notebooks, analytical records, and electronic documentation.
- Ensure compliance with GMP, GLP, Data Integrity, and internal SOP requirements.
- Support deviation investigations, OOS/OOT investigations, CAPA implementation, and change control activities.
- Ensure audit readiness and regulatory compliance.

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