Highly motivated individual with 15+ years’ of leadership experience in Biologics Manufacturing/MSAT (Downstream/Upstream/CQV) operations including Technology transfer, Scale-up, Process validation and commercial manufacturing operations for the purification of Monoclonal antibodies, Recombinant proteins, Hormones, Fusion proteins, Viral vector vaccines, Adeno associated virus vector therapy (AAV) and Plasma derived therapeutic proteins produced by Microbial, Mammalian cell lines (CHO,HEK), Yeast cells and natural sources. Handled various process scales from 1L to 20KL batch sizes by using both SS & single use platforms. Have great exposure on global and domestic regulatory audits (EMEA, MHRA,FDA,WHO & DCGI etc.).Specialty: Continuous Manufacturing/cGMP operations/ MSAT/QMS/TQM/CQV (Commissioning Qualification Validation)/ Process validations,/Viral validations/Regulatory audits(FDA & EMA etc.), Scale-Up & Scale -Down applications, Lean management/Product life cycle management/Technology tranfer,Cell Culture/Downstream.Projects handled : DS operation of recombinant therapeutics expressed in Mammalian & Microbial, Plasma platforms - Mabthera, Enbrel, Bevacizumab, EGFR, GCSF,PegGcsf,GMCSF, IL-2,Human Insulin,Insulin analogues,Fc,Fab Fragments,Human plasma proteins (Cohn & Hybrid technology- Albumin, IgG, FIX,FVIII),Adeno associated virus vectors(AAV) & Viral vaccines.