Research Associate : Pharma Research Injectable

Lupin; Maharashtra; On-site; INR 600,000 - 900,000; Full time

Job summary

Lupin in Pune invites a Research Associate to drive analytical method development and validation for injectable products, including AMV/AMT/AME studies, data generation, and compliance with GLP/GMP.

You will operate HPLC/UPLC, GC, UV and other instruments, prepare protocols, and support transfer and equivalency work, ensuring accurate results for critical pharmaceutical programs.

Qualifications

• Lead AMV/AMT/AME studies for injectables (assay, related substances, content).
• Prepare test data sheets, protocols and reports for AMV/AMT/AME.
• Develop feasibility studies for injectable tests (assay, related substances, preservative content, molecular weight, cleaning).
• Support injectable projects by addressing analytical queries and related activities.
• Operate and calibrate analytical instruments.
• Perform routine and stability analysis for injectables.
• Evaluate excipients used in injectable products.
• Maintain GLP/GMP compliant lab environment.

Responsibilities

• Lead analytical method development, validation (AMV), transfer (AMT), and equivalency (AME) studies for injectables.
• Prepare data sheets, protocols and reports for AMV/AMT/AME studies.
• Conduct analytical method development and feasibility studies for injectable tests.
• Support injectable projects by addressing analytical queries.
• Operate and calibrate analytical instruments.
• Perform routine and stability sample analysis for injectables.
• Ensure GLP/GMP compliance in the laboratory.

Skills

Analytical method development

Method validation

AMV/AMT/AME studies

GLP/GMP compliance

Instrument calibration

HPLC/UPLC

Zetasizer / particle size

Data analysis

Tools

HPLC System

UPLC

GC

UV

KF / coulometer

Autotitrator

Zetasizer

Job description

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Research Associate : Pharma Research Injectable

Date: Aug 12, 2026

Location: Pune_RD, MH, IN

Company: Lupin

Job Description

• Expertise in analytical method development and validation for injectable products, including assay, related substances, content estimation, molecular weight determination, CCIT, particle size distribution, zeta potential, and cleaning validation.
• Experience in forced degradation studies, analytical method transfer (AMT), and analytical method equivalency (AME).
• Hands‑on experience with instruments such as HPLC, UPLC, GC, UV, KF/coulometer, autotitrator, and zeta sizer.

Core expertise

• Lead analytical method development, validation (AMV), transfer (AMT), and equivalency (AME) studies for injectable products, including assay, related substances, content estimation, molecular weight determination, CCIT, particle size distribution, zeta potential, and cleaning validation.
• Prepare test data sheets, protocols, and reports for AMV, AMT, and AME studies.
• Conduct analytical method development and feasibility studies for injectable product tests such as assay, related substances, preservative content, molecular weight, and cleaning methods.
• Support injectable projects by addressing analytical queries and related activities.
• Operate and calibrate analytical instruments.
• Perform routine and stability sample analysis for injectable products.
• Evaluate excipients used in injectable products.
• Carry out daily analytical laboratory activities in compliance with GLP/GMP guidelines.
• Maintain the work area in accordance with GLP, GMP, and safety guidelines.