Sr Research Associate, Analytical R&D

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

Job summary

Endo is seeking an analytical R&D chemist in India with 4–7 years of experience to develop and validate analytical methods for testing of APIs and release per ICH requirements.

The role requires strong GMP knowledge and hands-on work with wet analysis and instruments like HPLC, GC, GCMS, IR, and LCMS. The candidate will ensure GLP/cGMP compliance, support method transfer, and contribute to regulatory documentation.

Qualifications

• 4–7 years of experience in analytical chemistry for APIs.
• Experience in developing and validating analytical methods per ICH.
• GMP/GMP-GLP compliant lab operations.

Responsibilities

• Ensure GLP/cGMP compliance in ARD Lab and maintain instrument cleanliness.
• Develop analytical methods for projects and ensure timely validation/transfer.
• Support regulatory requirements per committed timelines.
• Provide analytical support to production for yield improvement and process optimization.
• Analyze RM, in-process, intermediates, stability, and API; report preparation.
• Document analysis of reference standards and ensure data integrity.
• Maintain analytical instruments and support calibration/PM.
• Review analytical documents and maintain HPLC/GC columns.
• Assist with partial validation, holding studies, DMF queries, and physicochemical studies.
• Handle QMS changes, deviations and CAPA activities.

Skills

Analytical method development

Regulatory compliance

GLP & cGMP knowledge

Wet chemistry

Education

Postgraduate chemistry/Analytical

Tools

HPLC

GC

GCMS

IR

LCMS

ICP-MS

Job description

Job Description Summary

• We are seeking a highly motivated analytical R&D chemist to join our research and development team.
• We require 4 to 7 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.