- Managing all upstream activities starting from assemblies preparation, Media preparation, Vial thaw, Feed preparation and filtration, Bioreactor operations to Batch harvest. Monitoring and process control of specific operations of Upstream.
- Project Management
- Involving in every phase of commissioning and Qualification activity of BMP1
- Maintenance and Calibration of Operations equipment in coordination with Maintenance Department.
- Monitoring of process efficiencies.
- Reporting of non-conformities and implementation of corrective/preventive actions in specific areas of operation.
- Preparation and review of Operations related procedures.
- Preparation, revision and review of Batch Manufacturing Records.
- Upstream Processing of in house and contract research projects
Preferred candidate profile
- Capable of shift supervision for USP operations
- Manage shift schedule for USP operations.
- Capable of preparation,
revision, and review of master Batch Manufacturing Records (BMRs
- Capable of reviewing the executed batch records (BMRs)
- Capable of identifying gaps in existing system or procedure and provide solution for the same.
- Capable of handling client and regulatory audits
- Decent following-up tendency to get the work completed within timelines.
- Knowledge in handling and troubleshooting Fermentation process & process scale up.
- Pre-seed, Seed / Inoculum development, Microbial expression platforms.
- Manpower management.
- Instrument handling & Buffer/Reagent preparation - pH meter, Spectrophotometer, Batch centrifuge, continuous centrifuge, LAF, shaker incubator, Autoclave, Microscope, SDS Page