JOB RESPONSIBILITIES • Review of Literature summary report, patent summary report and development protocols.

- New product development, Planning and Resource allocation for Domestic, ROW, US, EU, CMO Market.
- Alternate source development for API and Excipients, GC improvement of existing products.
- Timely execution of scale up/ exhibit/process validation of allotted projects.
- Process improvement and troubleshooting of existing commercial products.
- Overall review of Formulation Development data during stage gate clearance.
- Execution of allotted projects in stipulated timeline & within budget.
- To check feasibility of manufacturing and costing of all current projects for UID.
- Timely review of LNB and project files for allotted projects.
- To coordinate with CFT team like AR Lab, Production, Manufacturing, QA/QC for timely completion of project.




- Ensure timely address of regulatory deficiencies for Domestic, ROW, US, EU, and CMO Products.
- Compilation and review of the FnD data, interpretation and summarize the recommendations.
- Preparation and Review of technical documents such as MFC, SOP, PDR, TTD protocol, MMD, FPS and development protocol.
- Ensuring the availability of manufacturing and analytical requirements/documents and resources before execution of batches at plant.
- To evaluate the deviations noticed during technology transfer at shop floor and perform root cause analysis and rectification after consultation with the concerned department.
- Ensure adherence to guideline in various product development activities during development

📌 Research Associate (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka