30 Aug
|
Aragen Life Sciences
|
Hyderabad
30 Aug
Aragen Life Sciences
Hyderabad
We are seeking a highly motivated and detail-oriented Analytical R&D; Skilled 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 solid 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.
📌 Analytical Research Associate Sr Research Associate Hyderabad
🏢 Aragen Life Sciences
📍 Hyderabad