Research Associate : Pharma Research Injectable

About the Role

This position focuses on analytical method validation, transfer, and equivalency for injectable products, ensuring compliance with GLP/GMP guidelines and supporting injectable project activities.

Responsibilities

• Lead analytical method validation (AMV), transfer (AMT), and equivalency (AME) studies for injectable products, including assay, related substances, content estimation, molecular weight determination, container closure integrity testing (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 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, including HPLC, UPLC, GC, UV, KF/coulometer, autotitrator, zeta sizer, Mastersizer, and USP Type-I, II, and IV apparatus.
• Perform forced degradation studies and ensure compliance with GLP/GMP guidelines.
• Carry out daily analytical laboratory activities while maintaining the work area in accordance with GLP, GMP, and safety guidelines.

Requirements

• 4 to 6 years of relevant work experience in analytical method validation for injectable products.
• Hands-on experience with instruments such as HPLC, UPLC, GC, UV, KF/coulometer, autotitrator, zeta sizer, Mastersizer, and USP Type-I, II, and IV.
• Experience in forced degradation studies, analytical method transfer (AMT), and analytical method equivalency (AME).

Qualifications

• Master’s degree in Pharmacy or Science.