Job Description

Department DetailsRole Summary1. Driving new facility design; Concept, Basic and Detailed engineering design with focused effort on Upstream and Downstream Unit operations.
2. Support 2KL SU and 6 KL SS mAb manufacturing facility Scale up and technology transfer.
3. Upstream and Downstream equipment and process trouble shooting; Bioreactors, Centrifuge, chromatography skid, Filtration systems, UFDF/TFF, Filling station, Freeze Thaw etc.,
4. Knowledge on Monoclonal antibody manufacturing process and support production operations.
5. Handle CAPEX requirements for multiple drug substance facilities - 2KL and 6 KL scale.
6. Key driver to bring new technology and systems into production facility.
7. Active support in Process and Cleaning validation.
8. Drive process automation for equipment's - Handling recipes/phases etc.,
9. Drive process trouble shooting and investigation with CAPA identification.
10. Perform Technology transfer/facility fitment assessment for new products.
11. Handle software tools like SuperPro/SchedulePro (Process simulations).
12. Perform process analytics/model creation using SIMCA and other standard analytical tools.
13. Drive the equipment Qualification: (review of FAT, SAT protocol and preparation of in-house DQ, IQ, OQ and PQ protocol and report)
14. Basic Automation knowledge for recipe (Siemens PCS7, CCP, Unicorn and other platforms) and MES support
15. Complying with EHS policies.
16. Complying with cGMP practices as per SOP, batch records and protocols.
17. Preparation and review of cGMP documents like SOP, batch records, checklists, registers, protocols and reports.Key Responsibilities1. Driving new facility design; Concept, Basic and Detailed engineering design with focused effort on Upstream and Downstream Unit operations.
2. Support 2KL SU and 6 KL SS mAb manufacturing facility Scale up and technology transfer.
3. Upstream and Downstream equipment and process trouble shooting; Bioreactors, Centrifuge, chromatography skid, Filtration systems, UFDF/TFF, Filling station, Freeze Thaw etc.,
4. Knowledge on Monoclonal antibody manufacturing process and support production operations.
5. Handle CAPEX requirements for multiple drug substance facilities - 2KL and 6 KL scale.
6. Key driver to bring new technology and systems into production facility.
7. Active support in Process and Cleaning validation.
8. Drive process automation for equipment's - Handling recipes/phases etc.,
9. Drive process trouble shooting and investigation with CAPA identification.
10. Perform Technology transfer/facility fitment assessment for new products.
11. Handle software tools like SuperPro/SchedulePro (Process simulations).
12. Perform process analytics/model creation using SIMCA and other standard analytical tools.
13. Drive the equipment Qualification: (review of FAT, SAT protocol and preparation of in-house DQ, IQ, OQ and PQ protocol and report)
14. Basic Automation knowledge for recipe (Siemens PCS7, CCP, Unicorn and other platforms) and MES support
15. Complying with EHS policies.
16. Complying with cGMP practices as per SOP, batch records and protocols.
17. Preparation and review of cGMP documents like SOP, batch records, checklists, registers, protocols and reports.Educational QualificationsRequired Education Qualification: Msc
Required Experience: 1 - 4 years

Biocon