I have over 20 years’ experience within CMC, Business Development, Strategy, Operations and Project Management including expertise in technical transfer, cell culture, CAR-T and cellular therapies, cGMP clinical and commercial manufacturing, and contract manufacturing management. I have effectively managed cross functional teams for biologics and cellular therapy cGMP operations, setting priorities and action plans and evaluating risk. Throughout my years of experience, I have taken on roles of ever increasing responsibility, including accountability for all management aspects of the life science business and manufacturing lifecycle projects, from budget/pricing/revenue/contracts to volume projections and implementation. Some of my key strengths consist of my interpersonal skills and ability to bring cross functional teams together, which enable these teams to deliver on project goals by establishing and communicating the program objectives across the team while tracking progress against key milestones. Specifically, I have expertise in business development, strategic client engagement, commercial contract negotiations, and collaboration within industry, academia, and government. Operationally, I have experience with regulatory audits, including successful EMA certification for cGMP manufacturing, FDA pre-approval inspections, and FDA end-of-phase II clinical program meetings. I have 13+ years of direct personnel management, organizational development, talent identification and hiring, and a great track record of internal personnel promotion to retain strong talent within the organization. My cGMP experience includes extensive focus on quality management, including change control, effective deviation investigation and CAPA implementation to ensure elimination of repeat quality issues, and conducting internal audits to effectively prepare for external audits.