Analytical | Research Associate | Sr. Research Associate
Aragen Life Sciences Limited · Hyderabad · onsite · Posted 56d ago
Undisclosed2–5 yrsfulltimeSourced from
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About this role
We are seeking a highly motivated and detail-oriented Analytical R&D Professional to support analytical development activities for CDMO projects. The candidate will be responsible for analytical method development, validation, stability studies, impurity profiling, and regulatory-compliant analytical documentation. The role requires strong expertise in chromatographic techniques and compliance with pharmaceutical quality standards
Key Responsibilities
- Develop, optimize, and validate analytical methods using HPLC, UPLC, GC, and other analytical instruments.
- Perform method validation, verification, and method transfer activities in accordance with ICH guidelines.
- Conduct impurity profiling, forced degradation studies, and stability studies for APIs, intermediates, and drug substances.
- Support Process R&D, Manufacturing, Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs teams.
- Prepare, review, and maintain analytical protocols, reports, SOPs, specifications, and technical documentation.
- Ensure compliance with cGMP, GLP, Data Integrity, and applicable regulatory requirements.
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Skills
Analytical Method DevelopmentLCMSMethod DevelopmentMethod ValidationHPLCGCAnalytical ResearchResearch And Development