Photo of Kristina Carroll

Kristina Carroll

Systems Engineering, MBSE

Kristina earned a Bachelor’s degree in Chemical and Biological Engineering from University of Colorado at Boulder and a Master’s degree in Biomedical Engineering from Rutgers University.  She started her career in the medical device industry at Terumo BCT where she was a Systems Engineer supporting cell processing systems and co-developed and deployed a requirements engineering training program.  Kristina was responsible for post-market surveillance, hazard and FMECA analyses, and using MBSE to maintain system architecture and requirement traceability to adhere to the FDA’s requirements for Design Controls.  

In 2017, Kristina transitioned to the cell and gene therapy field as a Process Engineer on the CMC team at Precision BioSciences Inc.  She used her MBSE skills to develop an IND-enabling, scalable manufacturing process for production of allogeneic CAR-T cells and cold chain logistics to support drug product shipments from manufacturing organizations to clinical sites.  Kristina used MBSE to model patient enrollment, ordering, dose preparation and administration logistics enabling flawless, on-time dosing of Precision’s first patient in clinical trials.  Kristina also performed comprehensive technical risk assessments to transition the manufacturing process from early to late phase development and was responsible for developing user requirement specifications for custom materials and equipment.  Kristina later joined Atsena Therapeutics, Inc. to lead process and assay development.  She coached her team on basic system engineering principles which enabled rapid realization of an in-house research grade viral vector manufacturing process and transitioned in-house analytical capabilities from early-stage development to qualified, GMP-ready assays.  

In 2023, Kristina transitioned to joining Studio SE as the Director of Product Development and continuously develops MBSE and SysML training courses and consults for and trains a multitude of industries on the use and deployment of SysML and consults.  In her free time, Kristina enjoys hiking, camping, and spending time with her family.