Purchase management, and vendor management to ensure the availability of all required resources (raw materials and spares) for upcoming projects.Handling and managing technical and documentation systems of various projects for process validation and process scale-up.Scale up planning and support to manufacturing 500 L SS bioreactor and 2500 L SS bioreactor during technology transfer.Vendor assessment and Batch harvest optimization by depth filtration and scale-up at 20L to 500L and 2500L bioreactor.Planning and execution of FMEA assessment and scale-down modeling for process characterization studies for various projects.Planning, Handling, and real-time analysis of multiple reactors to minimize product timeline.Training of new FTE and team members, teamwork plan management according to project timeline,Batch resource management and inventory management. Lab management, Equipment management, and coordination with vendors for timely maintenance of equipment.Cross-functional team management for timely execution of in-process samples for process improvement.

Process development & Execution of experiments to meet the quantitative and qualitative expectations of biosimilar different types of monoclonal antibodies. Document preparation like consistency report, tox. the study report, tech transfer document, BMR preparation, and Process development report at different stages of the product timeline.Planning, Handling, and scaling up of Sartorius bioreactor at different scales for the engineering campaign which includes a 5 L glass bioreactor, 50 L SUB, 500 L SUB, and 2000 L SUB.Handling of ATF to assess the accelerated performance of the developing process.Handling of small-scale rectors (Dasgip 250) for identification of operating ranges of process parameters.Data entry, analysis, batch comparison, and data interpretation of process developmental.Equipment management, and coordination with vendors for timely maintenance of equipment.Batch resource management and inventory management.

Review and data verification of project-related R&D-related documents based on priority.Qualification, Monitoring, and Management of R&D Equipment system for smooth project execution.Managing, Monitoring, and scheduling internal audits in departments, handling internal audit observation and response for upcoming audit preparation of R&D labs and internal systems for different types of audits (EMA, FDA, HC, etc.)