Research Associate / Senior Research Associate- Analytical Department

Job Description

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

The ideal candidate will have 1 to 7 years of hands-on experience in using advanced analytical instrumentation including Ion Chromatography ( IC) , GC, GC-MS, LCMS and 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 ICP-MS, Ion Chromatography (IC), GC, GC-MS, LCMS, HPLC.
• 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.
• 1 to 7 years of relevant industry experience in pharmaceutical analytical development.
• Proficient in handling and troubleshooting ICP-MS, Ion Chromatography (IC), GC, LCMS, GC-MS, HPLC instruments.
• Strong understanding of regulatory guidelines (ICH, USFDA, EMA) related to analytical method development and validation.

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