Research Associate : Pharma Research Injectable

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

Job summary

Lupin in Pune, MH seeks a Research Associate for Pharma Research Injectable to lead analytical method development and validation for injectable products. You will work on AMV, AMT, AME projects, and handle instruments like HPLC, UPLC, GC, and UV.

You will prepare test data sheets, reports, and support GLP/GMP compliance in daily lab activities, including method transfer and stability analysis. Collaborate with cross-functional teams to ensure documentation quality.

Qualifications

• Experience in analytical method development and validation for injectable products.
• Experience in forced degradation studies, AMT, and AME.
• Hands-on experience with instruments such as HPLC, UPLC, GC, UV, KF/coulometer, autotitrator, and zeta sizer.

Responsibilities

• 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.

Skills

Analytical method development

Validation

Method transfer

Analytical instruments

Tools

HPLC

UPLC

GC

UV

KF Coulometer

Autotitrator

Zeta sizer

Job description

Select how often (in days) to receive an alert:

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.