Summary of engagements from 2020 to date

• Provided fractional CMC leadership for a mAb drug substance development and clinical product supply from a CDMO

• Generated a QbD-based CMC development roadmap for a CAR-T cell therapy product

• Created and managed a comprehensive CMC development plan for a clinical stage Biologic

• Performed CMC due diligence for two late-stage mAb acquisition assets

• Led GMP readiness project for clinical autologous CAR-T cell manufacturing

• Managed a commercial autologous CAR-T manufacturing transfer to a new site

• Transfered and redesigned a Phase 3 mAb manufacturing process 

• Fractional CMC management and oversight of a Bologic product supply from CDMOs

• Designed and implemented a comprehensive knowledge management system for VLP-based gene therapy

• Optimized AAV-based gene therapy manufacturing process at a CDMO and transfered to in-house facility

• Led CMC development of a recombinant version of a commercial plasma fractionation-derived biologic, from gene sequence through research cell bank generation to production of material for the proof of concept

• Provided process, quality, and manufacturing operations SME input for a design of viral vaccine manufacturing facility