29 Aug
|
Aragen Life Sciences
|
Hyderabad
29 Aug
Aragen Life Sciences
Hyderabad
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 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