Products:Omalizumab/HKA 

Section Manager 

USP

 Support Manufacturing 

 Leading Shift Team and Improvement Projects 

Section Manager 

DSP

 Audit preparation, Leading Audit discussions, Response (FDA, EMA, HSA, GCA audit) 

 Creation of Standard batch progression 

 Continuous Improvement projects 

 Green Belt for reducing XOLAIR DSP process cycle time 

 Active member for XOLAIR Batch record RFT process 

 Special Achievement for Column Packing and Spot Award for Root cause Analysis of production issues 

 Optimized TFF process and improved yield at the Final Fill stage of process Shift Manager 

 Lead Shift Team and managing Routine 

production 

 High performing team with 0 Human error deviations Senior Biotech, 

Shift Lead 

 Lead Downstream Manufacturing - 

Commissioning, Qualification of Equipment and Cycle Development studies 

 SIP HOLD time study, Buffer Mixing Time study, CHT, DHT studies, Column Packing 

studies 

 Spot award for SIP HOLD study, Column pack study 

 Automation recipe development and testing 

 Specialized in UFDF operations and optimized the process with 0 alarms 

Product:Factor VIII 

DSP

 Techniques – Chromatography (Mab, Ion 

exchange), Viral Inactivation, Column Packing 

 Analysis – Chromatographic trends, overlays, step yield data 

 Software systems – PALL system, GE UNICORN, Siemens 

 Certified on yellow belt and orange belt courses for investigating and solving manufacturing issues. 

 Participated in FDA, EMA audit 

 SOP, BR, CAPA, DEV management 

Product:Rituximab

DSP

 Lead for handling deviations (CAPA) and Change control Activities. 

 Involved in Equipment, process and cleaning validation 

 Performed projects in downstream processing for increasing the recovery of protein and preventing loss of protein from the system 

 Team Leader for Product Change over activities. 

 Scheduling of downstream activities and planning of Buffer and other requirements for the process 

DSP 

 Process development of H1N1, H3N2, B Bris strains of flu vaccine produced using Insect cell lines and purified by chromatographic columns, TFF and viral Inactivation techniques. 

 Analysis - Spectrophotometric Analysis, Endotoxin Analysis using gel clot method. 

 Team Lead for Downstream processing area 

 Lead for Scale up –scaling up of chromatographic columns, TFF, upstream cell lines in wave bag, disposable stirred tank reactor systems 

 Involved in Equipment Qualification and Participated in RCGM audit 

USP/DSP 

 DSP techniques – From Harvest to fill 

 Upstream Techniques – Fermenter handling, microscopic analysis. 

 Analysis- Gas chromatography, UV spec analysis 

 BR,SOP, Logbook Management 

 Lead for process and cleaning validation