Senior Lead Scientist - Syngene International Limited
(2023-03)
- Lead analytical development activities including method development, validation, and transfer for various dosage forms (solid orals, injectables, and topicals).
- Executing method development, particularly for chiral molecules.
- Oversee stability studies, data review, and trend analysis to support product shelf-life determination.
- Drive investigations for OOS, OOE, and OOT, ensuring robust root cause analysis and regulatory compliance.
- Manage analytical method transfers to manufacturing sites and ensure successful execution.
- Ensure adherence to cGMP and ALCOA+ principles in all analytical documentation.
Assistant Manager - Caplin Point Laboratories Ltd.
(2022-06 - 2023-03)
- Developed and validated analytical methods (HPLC, dissolution, assay, related substances) in line with ICH and USP guidelines.
- Conducted forced degradation studies and established stability-indicating methods.
- Reviewed analytical data and prepared validation protocols and reports.
- Supported regulatory submissions through accurate documentation and data integrity compliance.
Research Associate – IV - Aurobindo Pharma Pvt. Ltd.
(2019-09 - 2022-06)
- Performed routine analysis and stability studies for topical formulations.
- Investigated analytical deviations (OOS/OOT/OOE) with scientific justification and impact assessment.
- Contributed to method validation and preparation of analytical reports.
Research Associate - Aleor Dermaceuticals Ltd.
(2017-03 - 2019-09)
- Conducted analytical method development for topical and solid oral dosage forms.
- Performed pre-formulation and stability studies for R&D batches.
- Carried out instrument calibration and maintained compliance with laboratory standards.
- Documented analytical results in accordance with cGMP and data integrity requirements.
