Assistant Manager

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 new 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