· Tech Lead for biologics downstream process development project. Currently, leading & managing team of scientist/engineers for process development. Led process planning, scheduling project activities and monitoring various project aspects like resource planning, logistical challenges and supervision. Led RCAs, investigations & implementation of CAPAs. Experienced with planning & designing of single use production facility. Experienced with QbD and DoE

. Led and executed mAb chromatography process development studies using AKTA systems. Executed resin screening study for DNA removal. Experienced with depth filtration and TFF (mAb and virus). Conducted filtration screening & capacity studies for various clients. Completed technology transfer from client to APC. Experienced with scale up and production capacity calculations for filtration and chromatography. Liaising with quality team for process validation protocols, SOPs and risk assessment· Lead client communications on project planning, experimental design and results. Experienced in various protein and virus estimation techniques (HPLC, qPCR, TCID50 etc)

• Designed and constructed vectors for protein expression and purification.• Isolated and purified plasmid and genomic DNA.• Used various techniques like PCR, restriction digestion, ligation and transformation for molecular cloning.• Performed DNA gel electrophoresis.• Performed small scale fermentation operation for protein expression (2 L).• Expressed His tagged protein (Deformylase) in E.coli.• Optimized protein yields and conducted whole cell assays for protein activity.• Optimized protein purification (AKTA prime) using Immobilized metal affinity column chromatography.• In vitro assay development.• Kinetics and Substrate studies.• Used various techniques like HPLC, GC-MS-FID, UV-Vis Spectrophotometer and SDS-PAGE for protein characterization.• Collaborated with research groups for biophysical studies.