Research Scientist - ADL

Lupin Manufacturing Solutions Limited (LMSL); Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Lupin Manufacturing Solutions Limited (LMSL) is seeking a senior-level Analytical Scientist to lead method development, validation, impurity profiling, and structure elucidation. You will drive analytical projects across APIs, intermediates, and in-process samples while ensuring regulatory compliance and data integrity.

The role requires hands-on expertise with HPLC/UPLC, LC-MS/MS, NMR, GC, FTIR, and UV spectroscopies, plus strong leadership and cross-functional collaboration with R&D, QA, and

Qualifications

• Develop, optimize, and validate analytical methods for APIs and intermediates.
• Perform method development/validation using HPLC, UPLC, GC, LC-MS/MS, UV and related techniques.
• Execute assay and impurity method validations per ICH guidelines.
• Prepare validation protocols, reports, and regulatory documentation.
• Support troubleshooting, method transfer, and tech transfer activities.
• Conduct impurity profiling and structural elucidation studies.

Responsibilities

• Lead analytical method development and validation projects for APIs and intermediates.
• Perform impurity profiling and degradation studies for regulatory submissions.
• Interpret NMR, MS, FTIR/UV data for structure elucidation.
• Manage instrument maintenance, calibration, and data integrity.
• Coordinate with R&D, QA, Regulatory, and Manufacturing teams.

Skills

Analytical Method Development

Validation

Impurity Profiling

Structure Elucidation

Team Leadership

Project Management

Regulatory Documentation

Data Interpretation

Tools

HPLC/UPLC

GC

LC-MS/MS

NMR

FTIR

UV-Vis

Job description

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.