• Spearhead analytical method development, successful transfer to CDMO and oversee the qualification at QC team, enabling in-process, lot release, and stability testing• Lead all aspects of development for multiple QC friendly potency assays internally including experimental design, seeking input from team members and SMEs, drafting high-level timeline with milestones, overseeing execution of studies, reviewing data, providing recommendations on strategies and next steps• Authored all technical documents to support analytical method execution, including SOPs, development reports, qualification protocols and reports, sampling plans, and CMC analytical section of the IND filing

• Determine Treg sorting strategy, lenti vector titer, transduction efficiency, and cell phenotype to support process development, characterization studies, and manufacturing investigations• Participate in resource and project planning activities to define department goals, budget, and day-to-day operations, including new laboratory design and build up

• Mange external collaborations and drive innovation in advanced therapeutic platforms includes an automated viral transduction system and an automated gating sorting system. •

Cell therapy process development