Trained and proficient in various types of chromatography techniques for the purification process development and optimization of monoclonal antibodies such as affinity, AEX, CEX, HIC, and MMC. Worked on filtration techniques used in downstream such as TFF, depth filtration, and viral filtration. Responsible for technology transfer from R&D to Manufacturing (scaleup), Scale-down model (SDM) Qualification, Process Validation (PV/PPQ), and resin reusability study. Expert in designing study plans,… Show more Trained and proficient in various types of chromatography techniques for the purification process development and optimization of monoclonal antibodies such as affinity, AEX, CEX, HIC, and MMC. Worked on filtration techniques used in downstream such as TFF, depth filtration, and viral filtration. Responsible for technology transfer from R&D to Manufacturing (scaleup), Scale-down model (SDM) Qualification, Process Validation (PV/PPQ), and resin reusability study. Expert in designing study plans, execution, and report preparation to achieve project targets within associated timelines. Writing and reviewing protocols and technical reports for the execution of various studies like SDM qualification, Process Intermediate hold time and freeze-thaw study, FMEA, and PDR. Actively participating in high-quality technical discussions, data analysis, and presentations for internal or cross-functional teams. Software handled: JMP for statistical data analysis, DOE and GoSilico for chromatography modeling. Show less

Downstream process development and process optimization of recombinant protein (Fc tag, His-tag or untagged proteins and Monoclonal antibodies) through two/three step purification strategy. Bioconjugation of proteins, Enzymatic cleavage and purification of protein.Collating, analyzing and interpreting data from work/ study programs and offer advice when required externally to clients.Preparing and delivering presentation, protocols and reports with right first time quality. Involved… Show more Downstream process development and process optimization of recombinant protein (Fc tag, His-tag or untagged proteins and Monoclonal antibodies) through two/three step purification strategy. Bioconjugation of proteins, Enzymatic cleavage and purification of protein.Collating, analyzing and interpreting data from work/ study programs and offer advice when required externally to clients.Preparing and delivering presentation, protocols and reports with right first time quality. Involved in coaching and mentoring more junior members of the department related to research advancement in the downstream arena.Analytical expertise: SDS PAGE, Western Blotting, Endotoxin analysis. Show less

I was responsible for manufacturing operations related to downstream in Mammalian facility. Operation of chromatography systems, TFF systems, virus filtration vessel, DS filtration for protein purification.Preparation and review of GMP documents like SOPs, BPRs, qualification and validation protocols, investigation reports and other process or facility related documents. Execution of qualification activities related to equipment and process (Commissioning and qualification of Facility)… Show more I was responsible for manufacturing operations related to downstream in Mammalian facility. Operation of chromatography systems, TFF systems, virus filtration vessel, DS filtration for protein purification.Preparation and review of GMP documents like SOPs, BPRs, qualification and validation protocols, investigation reports and other process or facility related documents. Execution of qualification activities related to equipment and process (Commissioning and qualification of Facility). Preparation and execution of cleaning validation protocol. Show less