About this role
Description:
The position supports drug substance (DS) and drug product (DP) development through development, validation, and application of analytical methods to evaluate critical quality attributes. The role contributes to product development across dosage forms by performing quantitative, qualitative, and performance-indicative testing to align products with reference formulations. The role involves planning controlled experiments, evaluating trial batches, exposure, and stability studies, and setting product specifications. The position ensures laboratory setup, equipment compliance, and data integrity for regulatory submissions and also supports analytical method transfer, commercial troubleshooting, and exploratory computational and experimental research, leveraging scientific data to guide research decisions and innovation.
Essential Functions:
- Develop and apply analytical methods for DS and DP evaluation
- Perform identification, assay, impurity, and dissolution testing
- Evaluate formulation trials against reference product profiles
- Plan and execute controlled experiments on trial batches
- Conduct exposure and stability studies and document observations
- Support setting and justification of product specifications
- Perform analytical method validation as per intended use
- Ensure laboratory equipment operation, maintenance, and compliance
- Maintain data integrity for regulatory submission datasets
- Support analytical method transfer to commercial sites
- Troubleshoot analytical issues for R&D and commercial support
- Contribute to computational and experimental chemistry research
Additional Responsibilities:
- Raise indents, prepare Capex, and manage laboratory inventory.
- Taking responsibility to give training to junior for on job training
- Attend technical workshop /seminar and explore new technique and technology at work place
Education:
- Master Degree (MS/MA) M. Sc. - Required
- M. Pharm M. Pharm - Preferred
Experience:
- 5 years or more in 5 - 8 Years
Specialized Knowledge: Licenses: