Accountable for large scale commercial manufacturing of Insulin and analogs drug substance that includes production operations and process engineering, system design and organization building.Strategic operational planning & execution in downstream purification and scale-up of Biosimilar Insulin and analogs and decision maker for scale-up of new products in the manufacturing facility; Process analysis and implementation; Evaluation & Troubleshooting Team Building & Leadership; Quality & Safety Assurance (QA/SA); Regulatory affairs and compliance; Six Sigma & Lean Manufacturing Methodologies.Leading of operational team by providing direction and guidance for Organizational Structure, Lean Principles, Training, Documentation, Safety/GMP & Start-up strategy. Ensure a culture of empowerment and accountability across the Process Unit team and facilitate best practice sharing and establish clear goals/objectives insuring timely and efficient utilization of plant. Provide manufacturing team with technical directions, ensure effective resource planning, participates in the recruitment, training and assessment of all manufacturing staff, Ensure irreversible corrective actions are implemented in response to quality defects and manufacturing deviations, set direction to team; ensure they are properly guided, appraised, developed, trained, supported and motivated in the pursuit of their individual and collective goals.

Managing operations teams across three manufacturing suites - downstream processing of biotechnologically derived products. Responsible for commercial and development products manufacturing, dispatch operations, Technology transfer for new products, process optimization studies and yield improvement studies, execution of process validation and cleaning validation campaigns.

Decision making that requires in depth evaluation of extremely complex factors, anticipation of unknowns and interactions with multiple stakeholders including SCM and commercial streams. Various role in Insulin and analogs operations and trouble shooting, deviation management, scale up of new products, throughput improvement, implementation of operational excellence and problem solving tools,Played key roles in short and long term facility expansion plan for meeting organizational goals. Manufacturing capacity upgrade and expansion - equipment qualification, commissioning, performance qualification

Drive and implement management decisions to improve cost structure and process optimization.Closely monitoring and controlling of In process parameters to mitigate risk involved during purification of Human Insulin and analogs.Process scale up and productivity improvement.Planning and Execution of commercial and clinical manufacturing campaigns.

Production operations that includes Insulin downstream operations and dispatch operations. Follow ups and monitoring of brown field expansion activitiesProcess optimization, batch costing analysis, capex budgeting etc.Production inventory control, raw material planning, Batch trend analysis, CAPA for batch failure etc.

Played as shift in charge, involved in critical equipment operations of RPHPLC, Cell separator, centrifuge, Freeze drying, Autoclave, dry heat sterilizer, TFF, crystallization, Aseptic filtrations etc. Handled both small molecules and biological products downstream operations.RPHPLC operations and trouble shootingLow and medium pressure chromatography column (800mm and 1200mm dia columns) operations and trouble shooting.Unit operations involved Filtration, liquid-liquid extraction, crystallization, centrifuging, freeze drying, blending, sieving, dispatching