• Managed direct reports in clinical and commercial process development of AAV products• Authored and reviewed IND sections for an AAV product• Project lead on LIMS system launch

• Lead technology transfer efforts for clinical phase AAV purification process to external CMO• Lead the design and execution of viral clearance studies to support IND of an AAV product• Authored purification sections for pre-IND document

• Built infrastructure for and lead execution of internal GLP toxicology campaign• Designed and executed univariate and multivariate process development studies• Authored development reports for process development activities

• Carried out commercial program process development and technology transfer: harvest (centrifugation and depth filtration), capture, and viral inactivation on monoclonal antibodies and bispecific antibodies • Implemented quality by design approach in process development• Applied DOE and statistical expertise to process development • Authored technical documents: Development reports, SOPS, protocols, etc. • Participated in Technology Development Teams: continuous purification, process intensification, Raman spectroscopy, facilities continuous improvement

• Conducted preclinical/clinical program process development and technology transfer: harvest, capture, viral Inactivation, polishing, viral filtration, ultrafiltration/diafiltration • Executed end to end purification using various chromatography, membrane, and other purification techniques on various novel molecules including antibodies, bispecifics antibodies, antibody fragments, His-tagged proteins, etc.

• Researched and developed CCTC (Continuous Countercurrent Tangential Chromatography) to move towards commercialization • Managed analytical procedure development and processing including analytical protein A affinity chromatography, analytical size exclusion chromatography, UV-VIS spectroscopy• Evaluated affinity resin capacity and kinetics • Optimized CCTC System buffers• Conducted membrane performance, analysis, and scaling studies

• Worked with a team to design CCTC system• Carried out the custom construction of second and third generation hardware for CCTC system; This includes peristaltic pumps, solenoid valves, National Instruments DAQ hardware, pressure sensors, UV sensor, flow path assemblies utilizing hollow fiber membrane, integrated scales, a PC for process control, and multiple power supplies, all integrated into a custom made electrical box and controlled through in-house Labview software • Developed process control system for CCTC, including programming in LabVIEW• Installed, maintained, and repaired analytical instrumentation -• Executed product demonstrations for customers

• Developed and executed procedures for UF and MF hollow fiber membrane characterization including integrity, delta P, and permeability