API Research Analyst
MaharashtraFull-time2–5 yrsPosted 1 week ago
Mid-level project management role at USV in Maharashtra. Needs 2+ years and an M.Sc, B.Pharm or M.Pharm.
About the role
The primary objective of the Analyst (AR&D) is to perform analytical testing, method development, method validation, and analytical method transfer for pharmaceutical development, routine, initial, and stability batches. The candidate will ensure strict adherence to cGMP guidelines, regulatory standards, and HSE (Health, Safety, and Environment) policies, ensuring reliable analytical data reporting and operational efficiency within the laboratory.
What you'll do
- Analytical Testing & Method Execution
- Conduct analytical testing for routine, initial, stability, and development batches
- Perform Analytical Method Development and Validation (AMDV) for tests including Assay, Related Substances, Dissolution, and Particle Size Analysis
- Execute Analytical Method Transfer (AMT) protocols and generate reliable analytical data for regulatory deficiency responses and standard generations
- Conduct literature surveys to support analytical strategy and troubleshoot testing methodologies
What you need
- Research
- HPLC
- GMP
- SOP writing
- GLP
- Technical writing
Good to have
- Instrumentation
- Chemistry
- Business analysis
- Safety management
- Regulatory affairs
- Preventive maintenance