Research Associate, Analytical R&D

Endo; Perambalur; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Endo is seeking a highly motivated analytical R&D chemist to join our research team. The role focuses on developing and validating analytical methods for testing API according to ICH and regulatory requirements, with hands-on work on HPLC, GC, GCMS, IR and LCMS.

The candidate should have 2–5 years of experience, a postgraduate chemistry/analytical degree, and a strong grasp of GMP/cGMP principles, wet analysis, and data integrity to support production and regulatory timelines.

Qualifications

• : 2 to 5 years’ experience in analytical R&D and method development.

Responsibilities

• Ensure good housekeeping and adherence to GLP/cGMP norms in ARD Lab.
• Support and perform analytical method development for each project timely.
• Support and perform analytical validation/Method transfer for each project timely.
• Support regulatory requirements per committed timeline.
• Provide analytical support related to production for yield improvement and process optimization.
• Sample/analyze RM, KSM, in process, cleaning, intermediate, stability and API and report preparation.
• Analysis and documentation of Reference standard samples as per MTH.
• Support development/validation for EI by ICPMS and IC, GCMS, LCMS timely.
• Ensure completion of documents & data integrity and regulatory environment.
• Support calibration/Preventive maintenance of all analytical instruments.
• Review of all executed analytical documents.
• Maintenance for HPLC/GC Columns.
• Perform partial validation, holding study, DMF queries and physiochemical studies.
• Responsible for QMS system like Change control, Deviation and CAPA.

Skills

Analytical chemistry

HPLC

GC

GCMS

LCMS

GMP knowledge

Regulatory compliance

Wet analysis

Education

M.Sc. Chemistry

Tools

HPLC

GC

GCMS

IR

LCMS

ICPMS

Job description

Job Description Summary

We are seeking a highly motivated analytical R&D chemist to join our research and development team.
We require 2 to 5 years’ experience and Post graduate chemistry/Analytical in developing and validating analytical methods for testing of API and release according to ICH and regulatory requirements.
Having through knowledge of GMP operation and ability to work on Wet analysis and analytical instruments HPLC/GC/GCMS/IR/LCMS.

Job Description

To ensure good housekeeping and adhere to GLP/cGMP norms in ARD Lab and maintain cleanliness of instruments and equipment’s.

To support and perform analytical method Development for each project timely.

To support and perform analytical validation/Method transfer for each project timely

To support regulatory requirement as per committed timeline.

To provide analytical support related to production for sorting out issues, yield improvement and further optimizing the process as per schedule.

To Sample/analyze RM,KSM, in process, cleaning, intermediate, stability and API and report preparation

To Analysis and documentation of Reference standard samples as per MTH

To support and perform analytical method development/Validation for EI by ICPMS and,IC,GCMS LCMS timely.

To ensure completion of documents & data integrity and regulatory environment

To support for Calibration/Preventive maintenance of all analytical instruments

Review of all executed analytical documents.

Maintenance for HPLC /GC Columns.

To perform Partial validation, Holding study, DMF queries and physiochemical studies

Responsibility for QMS system like Change control, Deviation and CAPA and related to QMS.