Research Associate/ Senior Research Associate

We are seeking dynamic and detail-oriented professionals for the role of Research Analyst/ Senior Research Analyst/ Executive / Senior Executive in our ADL team and QA team.

The ideal candidate will have 2yrs to 7 yrs of hands-on experience in using advanced analytical instrumentation including HPLC.

The role involves developing and validating analytical methods, performing batch analysis, and supporting the overall analytical strategy for drug substances and drug products.

Key Responsibilities

• Analytical Method Development for drug substances and drug products using HPLC .
• Should have knowledge of RS (Related Substances).
• Analytical Method Validation in compliance with regulatory guidelines (ICH, USFDA, EMA).
• Routine and Stability Sample Analysis using validated methods to support formulation and process development.
• Perform instrument calibration, maintenance, and troubleshooting to ensure smooth lab operations.
• Prepare protocols, method development reports, validation reports, and SOPs as per regulatory standards.
• Conduct investigations, deviations, and ensure proper data integrity and documentation in line with GMP/GLP guidelines.
• Collaborate with cross-functional teams including Formulation, QA, and Regulatory Affairs for project deliverables.
• Ensure compliance with cGMP, GLP, and regulatory audit requirements.

Required Skills & Qualifications

• Masters degree in Pharmaceutical Sciences, Analytical Chemistry, or related field.
• 2 years to 7 years of relevant industry experience in pharmaceutical analytical development.
• Proficient in handling and troubleshooting HPLC instruments.
• Strong understanding of regulatory guidelines (ICH, USFDA, EMA) related to analytical method development and validation.