• Review of Literature summary report, patent summary report and development protocols. • New product development, Planning and Resource allocation for Domestic and ROW 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 and ROW Market. • 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