Senior Research Scientist

VIATRIS; Krishnagiri District, Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

VIATRIS in India is seeking a highly qualified professional to coordinate site transfers, trials, scale-ups and process validation across manufacturing sites. This role will ensure compliant execution of batches and related documentation.

You will review BMRs, MFRs and specifications for new product development, conduct risk assessments, and collaborate with R&D, QA, RA, SCM, and manufacturing to drive timely technology transfers.

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.

Job description

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.