Senior Research Scientist

Role & responsibilities :

• Coordinate with manufacturing sites for execution of trial, scale-up, optimization, and process validation batches, including associated documentations.
• Review Batch Manufacturing Records (BMRs) to ensure accurate and compliant execution of batches.
• Review and compile Exhibit Batch Summary Reports (EB Batches) for regulatory and internal documentation.
• Track and ensure timely completion of protocols for execution of transfer batches.
• Verify development data, Master Formula Records (MFRs), and specifications for new product development.
• Conduct specification reviews and compatibility studies for API source changes and new product introductions.
• Perform feasibility trials for site transfers and API source change activities.
• Review Process Validation Protocols and monitor critical manufacturing steps during validation activities.
• Ensure closure of all phases of protocol post execution of transferred batches.
• Prepare Risk Assessments for concerned sites involved in technology and site transfer activities.
• Collaborate with cross-functional teams (R&D, QA, RA, SCM, Manufacturing) to ensure timely and successful completion of site and technology transfers.