Senior Research Associate
Job Description
"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 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, 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"