Karin Abitorabi

Key role in Process Development (PD) efforts and experimental design to achieve FDA compliance (closed system, release assay development etc.) in preparation and support of the CMC (chemistry, manufacturing, and control) section for Pre-IND (investigational new drug) documentation. Training of QC staff in Flow Cytometry (acquisition and analysis) for release and FIO (for information only) phenotypic acquisition and analysis. Development of Flow Cytometry panels Close collaboration with QA and CMO

*Responsible for overall management and success of projects in Process Development Department. • 2 Direct Reports and close interactions with other departments (QA/QC/Manufacturing) on the East and West Coast • Active support of GMP manufacturing and client interactions to support phase I/II clinical trials • Active participation in writing and costing of contracts and proposals • Excellent written and oral communication skills evidenced by reports, BPR, SOPs, PD documents

11 Direct Reports from Manufacturing and Process Development Departments, reported to VP of Manufacturing • Responsible and Organized day-to-day operations for GMP manufacturing • Supervised GMP Manufacturing and Process Development personnel and activities for 5-6 different national and international client projects

*Project Management of multiple cell-based studies in parallel with national and international clients *Development of closed systems to bridge gap between Research and GMP manufacturing for clinical trials *Main Focus: Primary cells (autologous and allogeneic) for Cell Therapy applications *Technical transfer of client assays and generation of standard operating procedures (SOPs) and batch production records (BPR)