Analytical | Research Associate | Sr. Research Associate

Aragen Life Sciences Limited; Hyderabad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Aragen Life Sciences Limited is seeking an Analytical R&D Professional to support analytical development activities for CDMO projects in Hyderabad. The role focuses on method development, validation, impurity profiling, and regulatory-compliant documentation.

Expertise in chromatographic techniques and pharmaceutical quality standards is essential. The candidate will work cross-functionally with Process R&D, Manufacturing, QA/QC, and Regulatory Affairs to ensure robust methods and data

Qualifications

• Experience in analytical method development and validation.
• Proficiency with HPLC/UPLC, GC and related instruments.
• Familiarity with ICH guidelines and data integrity principles.

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.

Skills

Analytical methods

HPLC

UPLC

GC

Method validation

Stability studies

Impurity profiling

ICH guidelines

Data integrity

cGMP

Job description

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.