Job Description

Department Details

Role Summary

1. Plan and execute Technology Transfer process from Biocon R&D to drug product manufacturing sites and execute Developmental, Optimization, Scale up, Exhibit, Process validation batch manufacturing.
2. Serve as a scientific and technical representative for process related aspects
3. Perform trending and monitoring of critical quality attributes/critical process parameters to maintain product quality and to control process drift.
4. Identify and implement potential process improvements in collaboration with manufacturing operations.
5. Provide technical inputs related to process and operating parameters to projects and manufacturing function for new equipment\'s procurement.
6. Develop & Review SOPs for Development / Technology Transfer activity.
7. Support Regulatory affairs function by providing process related data for filing with regulatory authorities and respond to regulatory quarries related to drug product process
8. Provide technical support to manufacturing team to mitigate troubleshoot and process improvement.
9. Ensure compliance to cGMP procedures and practices during product introduction to drug product manufacturing facilities.
10. Provide impact assessment inputs to changes proposed to manufacturing process, proposed by R&D, QA, Manufacturing, Engineering, Regulatory and Validation.
11. Author and Reviewer of new processes and new products and the associated Technology transfer document, Risk Assessment, Facility fit assessment, Container fit assessment.
12. Author and Reviewer of Process Validation protocol and report.
13. Author and Reviewer Hold Time Validation protocol and report.
14. Author and Reviewer of Continued Process Verification (CPV) protocol. Analysis of batch data and trends and summary of CPV report.
15. Author and Reviewer of Protocol and technical reports for justification for process parameters, designation of critical where relevant, output attributes and ranges.
16. Author and Reviewer of protocol and technical reports to support process changes, modifications, improvements and scale up to support implementation at manufacturing scale. Review study protocols and reports for any trials to support the same.
17. Contribute during regulatory inspections and audits.
18. Handling of QMS elements.

Key Responsibilities

1 Monitoring and analysis of manufacturing data as necessary to provide support for process deviations, investigations, process transfers, or equipment troubleshooting.

2 Review of standard operating procedures and batch manufacturing records for changes made related to equipment or process for validated commercial products.

3 Training of manufacturing personnel for manufacturing process.

4 Data analysis and coordination of the execution of experiments aimed at improving process robustness/productivity or meeting the changing needs of the manufacturing environment for commercial products. (as needed)

Educational Qualifications

Required Education Qualification: BE/ B.Tech - Other
Required Experience: 3 - 6 years

Biocon