Scale Down Model Qualification & Process Characterization at 5L scale for late stage programs.Development and Consistency batches at 20L pilot scale.Scale Up and Tech Transfer

Predominantly engaged in early and late stage Process development for Monoclonal Antibody (Mab)production using CHO & NS0 cell lines.• Worked with Feb-batch and perfusion-based fermentationscale. Involved in designing, planning and execution of lab scale batches. Design of experiments (DOE)to optimize media & feed composition and Bioreactor parameters with a goal to maximize proteinconcentration and attaining biologically similar product quality has been mine major strength.• Clone selection, media screening and stability exercise• Risk assessment, SDM qualification, PC studies and Process Validationcampaign• Addressed Regulatory queries (FDA and EMA) and drafted dossier section for upstream.• Centre of Excellence (COE): I have been integral part of Centre of excellence for upstream Cell Culturedevelopment. The work involves in developing next generation process like continuous fermentation(ATF), Product quality improvements, Evaluation of PAT tools like Capacitance probe for CellCounting, NIR probe for Raw material identification & Batch prediction model.• Data analytics: Involved in the Statistical analysis of data, root cause analysis. Currently working withMultivariate Data analysis (MVDA) for building scale down model. Handled various statistical toolslike Minitab, JMP, Easy Analytics & SIMCA.• Scale Up & Technology transfer: Involved in Manufacturing GMP documentation, scaling up and,transferring the process upto 50L, 2000L & 6000L, Drafting & reviewing of technical reports,

Handling & Execution of 1kL and 2kL Single Use Bioreactor (SUB) for Clinical and Commercial Manufacturing of Monoclonal Antibody Drugs.PID controls and TroubleshootingInstrument Qualification and ValidationAseptical handling & Practicing Cell culture Techniques.