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 recent technique and technology at work place
Qualifications
Education:
Master Degree (MS/MA) M. Sc. - Required
M. Pharm M. Pharm - Preferred