Research Scientist - ADL

Lupin; Pune District; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Lupin is seeking an experienced analytical chemist in Pune to lead method development and validation activities for APIs and intermediates. The role covers impurity profiling, structure elucidation, and instrument management, with collaboration across R&D, QA, and regulatory teams.

Responsibilities include method transfer, regulatory documentation, and project leadership to ensure compliance with GMP/GLP and data integrity standards.

Qualifications

• Experience in analytical method development and validation.
• Proficiency with HPLC, UPLC, GC, LC-MS/MS, UV etc.
• Ability to prepare validation protocols and regulatory documentation.
• Ability to lead analytical teams and manage projects.

Responsibilities

• Develop, optimize, and validate analytical methods for APIs, intermediates, raw materials, and in-process samples.
• Perform method development and validation using HPLC, UPLC, GC, LC-MS/MS, UV and related techniques.
• Execute assay, related substances, and residual solvent validations per ICH guidelines.
• Prepare validation protocols, reports, and regulatory documentation.
• Support analytical troubleshooting, method transfer, and technology transfer activities.
• Conduct impurity profiling and characterization using LC-MS/MS and advanced analytics.
• Interpret structural information using NMR, MS, FTIR, and UV spectroscopy.
• Operate, troubleshoot, and maintain analytical instruments (HPLC/UPLC/GC/LC-MS/MS/NMR/FTIR/UV).
• Lead, mentor, and develop a team of analytical scientists.
• Coordinate with QA, Regulatory, Manufacturing, and R&D teams.

Skills

Analytical leadership

Project management

Regulatory documentation

Vendor coordination

Communication

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.