Overview
Research Associate I (R&D) for Complex Product Development focusing on computational and experimental characterization support for complex injectable drug products.
What you'll do
- Perform advanced characterization of complex injectable drugs using computational methods for regulatory submission under GLP norms.
- Manage outsourced studies at CROs, academic institutes, and external facilities from design through analysis and report preparation.
- Liaise with formulation and cross-functional teams as a Subject Matter Expert (SME) to address technical challenges.
- Maintain quality-compliant testing and data recording per approved SOPs/ALCOA++ and current pharmacopoeia in ELN with timely sign-off.
- Verify shelf life of chemical or reagent before analysis.
- Support lab operations including instrument operation, calibration, preventive and breakdown maintenance, and preventive/breakdown reporting.
- Track daily work status and communicate issues/non-compliance and action plans to the Sub-department Manager.
What you'll need
- Master’s (Pharmacy or equivalent) with 6–10 years of experience, or PhD (computational chemistry/biophysics or equivalent) with 0–5 years for experience range.
- Deep expertise in computational chemistry, molecular modeling, and molecular dynamics simulations.
- Proficiency in data analysis, including statistical methods for data interpretation.
- Basic understanding and hands-on experience in analytical methods such as CD, FTIR, fluorescence spectroscopy, or DLS (particle size distribution).
- Proficiency in literature search via publication and patent databases (e.g., PubMed) and regulatory webinars to stay updated.
- Knowledge of pharmacopoeia and ICH Guidelines for product development implementation.
- Experience with operation, calibration, preventive maintenance of NMR and other instruments for continued usage.
Details
- Location: Ahmedabad, Gujarat.
Read the full description and apply on the company’s own careers page.
