Job Description

Department DetailsRole Summary1. Author & Review for Tech Transfer documents preparation for CMOs (Wyzon, Virchow- ERIS, other CMOs & B1, B2-L1).
2. Development & PPQs batches execution support to CMOs Mfg. & Tech transfer team.
3. Author Product impact assessment for process and equipment-related deviations and out of specification investigations at CMOs site & L1.
4. Technical support for Root Cause Investigations for Process Deviations at CMOs site during development and PPQs & commercial support (If require).
5. Author Root Cause Investigations for OOS and OOTs for product attributes for in process, release, and stability.
6. Review of new processes and new products and the associated Technology transfer.
7. Review Hold Time Validation protocol and report.
8. Authoring/Review of Continued Process Verification (CPV) protocol. Analysis of batch data and trends and summary of CPV report.
9. Authoring/review Protocol and technical reports for justification for process parameters, designation of critical where relevant, output attributes and ranges.
10. Authoring/review protocol and technical reports to support process changes, modifications, improvements and scale up to support implementation at manufacturing scale. Authoring study protocols and reports for any trials to support the same.
11. Contribute during regulatory inspections and audits.
Secondary responsibilities (Wherever applicable):1. Manufacturing floor technical support in support of Clinical and Commercial campaigns
2. Monitoring and analysis of manufacturing data as necessary to provide support for process deviations, investigations, process transfers, or equipment troubleshooting.
3. Data analysis and coordination of the execution of experiments (run at Research and Development laboratories) aimed at improving process robustness/productivity or meeting the changing needs of the manufacturing environment for commercial products. (as needed)
4. Review of standard operating procedures and batch manufacturing records for changes made related to equipment or process for validated commercial products.
5. Training of manufacturing personnel for manufacturing process.Key Responsibilities1. Author & Review for Tech Transfer documents preparation for CMOs (Wyzon, Virchow- ERIS, other CMOs & B1, B2-L1).
2. Development & PPQs batches execution support to CMOs Mfg. & Tech transfer team.
3. Author Product impact assessment for process and equipment-related deviations and out of specification investigations at CMOs site & L1.
4. Technical support for Root Cause Investigations for Process Deviations at CMOs site during development and PPQs & commercial support (If require).
5. Author Root Cause Investigations for OOS and OOTs for product attributes for in process, release, and stability.
6. Review of new processes and new products and the associated Technology transfer.
7. Review Hold Time Validation protocol and report.
8. Authoring/Review of Continued Process Verification (CPV) protocol. Analysis of batch data and trends and summary of CPV report.
9. Authoring/review Protocol and technical reports for justification for process parameters, designation of critical where relevant, output attributes and ranges.
10. Authoring/review protocol and technical reports to support process changes, modifications, improvements and scale up to support implementation at manufacturing scale. Authoring study protocols and reports for any trials to support the same.
11. Contribute during regulatory inspections and audits.
Secondary responsibilities (Wherever applicable):1. Manufacturing floor technical support in support of Clinical and Commercial campaigns
2. Monitoring and analysis of manufacturing data as necessary to provide support for process deviations, investigations, process transfers, or equipment troubleshooting.
3. Data analysis and coordination of the execution of experiments (run at Research and Development laboratories) aimed at improving process robustness/productivity or meeting the changing needs of the manufacturing environment for commercial products. (as needed)
4. Review of standard operating procedures and batch manufacturing records for changes made related to equipment or process for validated commercial products.
5. Training of manufacturing personnel for manufacturing process.Educational QualificationsRequired Education Qualification: B.Pharma
Required Experience: 7 - 10 years

Biocon