Research Associate

Difgen-Pharmaceuticals-1; Hyderabad; On-site; INR 450,000 - 650,000; Full time

Job summary

Difgen-Pharmaceuticals-1 is seeking a skilled M. Pharm educated professional to lead analytical method development and related regulatory activities. The role emphasizes method development, validation/transfer of methods, and COA generation within a GMP environment.

The candidate will maintain cGLP/cGMP compliance, perform instrument calibrations (HPLC, IR, pH meters) and contribute to SOPs and protocol preparation with strong documentation practices.

Qualifications

• Experience in analytical method development and method transfer.
• Capable of preparing assessment, development and equivalency reports.
• Proficient in regulatory query handling and COA generation.

Responsibilities

• Execute Analytical Method Development for assays, dissolution, and related substances.
• Perform qualification and calibration of analytical instruments like HPLC, IR, and ancillary tools.
• Prepare protocols, SOPs, and testing procedures ensuring cGLP/cGMP compliance.
• Support method transfer activities from ARD to CMOs and ensure proper documentation.

Skills

Analytical Method Development

Regulatory queries handling

COA generation

GLP/GMP compliance

Documentation and reports

Education

M. Pharm

Tools

HPLC

IR

Water content analyzer

pH meter

Balances

Job description

Responsible for execution of Analytical Method Development (Assay, Dissolution, Related substances, content, UOD, PSD.), Analytical method feasibility activities of drug substance / drug product / excipients.Responsible for execution of activities related to Regulatory query and performing RLD analysis and COA generation.Responsible for preparation of assessment report, Method Development report, Method Equivalency report of drug product.Responsible for performing the qualification and calibration of analytical instruments like HPLC, IR and other standalone instruments (like water content, pH meter, Balances etc.,).Responsible for preparation of protocols / reports / standard operating procedures and Standard Testing Procedures.Responsible for following cGLP/cGMP compliance of the Analytical Laboratory, ensuring laboratory safety, good laboratory practices, Good Documentation practice in the lab and general cleanliness and Training & development activities.Monitoring and supporting all method transfer related activities from ARD to the CMO locations.Responsible for to execute authorized to sign (as prepared by) for, Certificate of analysis, Calibration record, Specification and Standard test procedure, Method Validation / transfer/Reverse Engineering / protocols and reports, Method equivalency report etc.M. Pharm