Schuyler Mesen
Associate Principal Process Engineer Cabaletta Bio
Schuyler (Gardner) Mesen is an Associate Principal Process Engineer with extensive experience developing and optimizing processes for autologous and allogeneic cell therapies. She has supported multiple clinical and late stage programs across the process development and manufacturing, science, and technology functions. At Cabaletta Bio, she leads process characterization and drug product PPQ readiness for the late stage CAR T therapy, resecabtagene autoleucel. She holds degrees from Cornell University and is committed to advancing cell and gene therapy manufacturing through data driven decision making and the application of Quality by Design (QbD) principles.
Seminars
Thursday 16th July 2026
A Risk‑Based Strategy for Process Characterization: Integrating Quality by Design, DOE, & Clinical Manufacturing Experience to Deliver a Robust BLA Data Package on an Accelerated Timeline
1:15 pm
- Developing risk assessments to justify and guide process characterization strategy
- Designing and executing statistically sound experiments (DOE) to identify critical process parameters (CPPs) and establish Proven Acceptable Ranges (PARs)
- Applying real‑world lessons learned to anticipate challenges and avoid common process characterization pitfalls
