- Execution of Process feasibility batches/scale-up batches in consultation with manager including at R&D & pilot plant/other units, supporting and addressing scale-up related issues.
- Preparation and execution of documents like Feasibility report/scale up/Pre exhibit batch report and review & approval of documents like BMR, BPR, PVP, and HTSP & PVR for exhibit batch required for regulatory submission.
- Evaluation of critical process parameters, process safety study of in-process checks, suggestion for changes for process feasibility at Unit, and optimizing, if required.
- Supporting for technology transfer of assigned projects from pilot scale/exhibit scale to commercial scale for achieving the process validation.
- Selecting the operating methods, facility requirements, and equipment for effective scale-up and troubleshooting in process scale-up activities.
- Identify the bottlenecks in the entire process well in advance and facilitate a solution for smooth and effective technology transfer of the assigned products.
- Revision of SOP for allocated equipment and maintenance of equipment.
- Responsible to coordinate with other Medreich pilot plants/Manufacturing Units related activities and Coordination of cross-functional teams and alignment as per the project needs for delivery as per committed timelines.