1. Evaluation of critical process parameter, process safety study of in-process checks, suggestion for changes for process feasibility at plant and optimizing.
2. Knowledge on oncology product scale up and equipment selection and handling shall be preferred.
3. Studying reaction calorimetric study, safety test, powder safety study, chemical compatibility & risk analysis for new processes
4. Preparing batch planning and coordinate use test
5. Selecting the operating methods, facility requirements, equipments for effective scale-up and trouble shooting in process scale-up activities
6. Co-ordinating with PD lab/R&D for experiments design for resolving the scale-up issue
7. Preparing the PFD, P&ID and batch planning
8. Discussing and coordinating with R&D, Production, Engineering, EHS, QC, QA & RA for smooth transfer of process in plant
9. Exhibit batches scheduling and meeting the Timeline and delivering the API qty to ANDA batches within stipulated time
10. Capacity planning & debottlenecking the capacities for higher capacity of API produced with compliance of cGMP & EHS guidelines
11. Calculating the RM cost, material balance, utility cost for each stage and compiling
12. To ensure HAZOP & Job safety analysis is being carried out before starting new product or any process change.
13. Trouble shooting and addressing the issues arise during scale Up