On-Demand

Lauren Smith
Chief Quality Officer and EVP, Manufacturing and CMC

Orca Bio
Profile
Lauren leads quality for Orca Bio. Lauren has been in the biotech industry for over 18 years with experience in small molecule, large molecule therapies including cell and gene therapies. Most recently, Lauren worked with Catalent where she was the Vice President of Quality for Cell and Gene Therapy and Biologics and supported the development and launch of numerous therapies. Lauren has a master’s degree and a B.S. in Biology with a focus on Microbiology from the University of Akron. Lauren currently sits on the board (compliance chair) for Axess Pointe-HRSA regulated community health centers.
Presentations
American Biomanufacturing Summit 2024
Defining and Supporting Digital Maturity in Biomanufacturing Operations
American Pharma Manufacturing & Outsourcing Summit 2025
Panel Discussion: Women In Leadership
American Pharma Manufacturing & Outsourcing Summit 2025