Andi has 10+ years of GMP cell therapy manufacturing experience. She has contributed to multiple CMC activities to support cell-based therapeutic products in phase II and phase III clinical trials, including aseptic manufacturing, supply chain and logistics, supporting GMP contract manufacturing for small molecule and regulatory submissions.
She has extensive experience training and managing Manufacturing, MSAT and Environmental Control Departments and developing systems and procedures needed to support GMP manufacturing operations. She has 10+ years of previous experience in basic research and analytics in a clinical laboratory setting. Her prior experience has led to comprehensive knowledge and understanding of Operations, Project Management and Quality Systems.