Associate Scientist - ADL

Lupin; Pune District; On-site; INR 800,000 - 1,500,000; Full time

Job summary

Lupin in Pune, India, is seeking an experienced analytical chemist to lead method development, validation, and transfer for critical pharmaceutical analyses using HPLC, UPLC, LC-MS/MS and HRMS.

The role covers stability-indicating assays, forced degradation, impurity profiling, and regulatory documentation in a cGMP environment, with close collaboration with Process R&D and Synthesis teams.

Qualifications

• Experience in developing and validating analytical methods per ICH guidelines.
• Ability to design experiments for forced degradation and stability studies.
• Experience with mass spectrometry-based impurity profiling.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• 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.

Skills

Analytical method development

Validation planning

Method transfer

ICH guidelines

cGMP compliance

Tools

HPLC

UPLC

LC-MS/MS

HRMS

UV spectrophotometer

Dissolution system

Job description

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.