Kristina Carroll
Lakewood,CO
Summary
Dynamic leader with extensive experience in model-based systems engineering and regulatory compliance at Studio SE, Ltd. Proven track record in developing advanced training programs and driving cross-functional collaboration. Adept at problem-solving and effective communication, delivering impactful results in aerospace and medical device industries.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Director of Product Development
Studio SE, Ltd
Larkspur, Colorado
08.2023 - Current
- Lead development of advanced MBSE/SysML training covering executable modeling, analysis, and best practices.
- Drive creation of company’s on-demand training platform featuring a SysML simulator and CATIA Magic video series.
- Continue to deliver MBSE training and consulting services across aerospace, defense, and medical device industries.
- Build model demonstrations for Dassault client engagements, illustrating practical MBSE applications.
- Author and deliver presentations at major conferences including INCOSE International Symposium and partner events.
Principal Trainer
Studio SE, Ltd
Larkspur, Colorado
08.2022 - 08.2023
- Delivered MBSE training across industries, introducing SysML and model-based engineering practices.
- Provided MBSE consulting services for U.S. government aerospace and defense contractors.
- Developed model prototypes and demonstrations showcasing MBSE value, influencing client adoption decisions
Associate Director of Process Development
Atsena Therapeutics
Durham, North Carolina
02.2022 - 08.2022
- Led comprehensive lab build-out efforts and oversaw the installation of IQ, OQ, and PQ processes.
- Managed AAV vector production and assay development teams.
- Directed strategic assay tech transfers to CDMOs, facilitating successful integration.
Process Engineer 3
Precision Biosciences
Durham, North Carolina
05.2021 - 02.2022
- Designed the Design of Experiments (DoEs) for the Process Sciences team, and provided technical oversight of execution.
- Reviewed and approved internal technical reports and data packages.
- Authored and reviewed CMC Drug Substance (DS) and Drug Product (DP) sections of IND submissions, including supporting technical reports.
- Authored the technical control strategy and risk assessments to support BLA preparation.
- Served as CMC representative on multiple programs, aligning CMC, QA, regulatory, clinical, and research functions.
- Contributed to CMC development plans and qTPPs.
Process Engineer 2
Precision Biosciences
Durham, North Carolina
04.2019 - 05.2021
- Supported the technology transfer of CAR-T manufacturing processes to an on-site GMP facility.
- Key contributor to next-generation manufacturing process development for cell therapies.
- Authored technical reports and risk assessments submitted with INDs.
- Investigated batch and clinical anomalies as clinical team's primary technical contact, providing data-driven root cause analyses.
Process Engineer 1
Precision Biosciences
Durham, North Carolina
04.2017 - 05.2019
- Developed IND-enabling manufacturing processes for allogeneic CAR-T therapies, scaling from research to large-scale manufacturing.
- Executed technology transfer of cell therapy processes to external GMP manufacturing partners.
- Established cold chain logistics for clinical delivery.
- Authored batch records, SOPs, and work instructions; trained operators, and served as person-in-plant for engineering and GMP runs.
- Served as on-site CMC representative for first patient, first dose.
Systems Engineer 2
Terumo BCT
Lakewood, Colorado
06.2013 - 04.2017
- Acted as a liaison between marketing and engineering, traveling to conferences with marketing to capture authentic user needs and translate them into system requirements.
- Developed stakeholder requirements for new devices supporting large-scale cell and gene therapy manufacturing, mapping manual processes to automated solutions.
- Authored device protocols for culturing and differentiating various cell types on bioreactors.
- Led the design planning phase gate for the Finia Fill Finish System.
Systems Engineer 1
Terumo BCT
Lakewood, Colorado
09.2012 - 07.2013
- Performed verifications of requirements, and managed the Failure Modes & Effects Analyses (FMEAs).
- Conducted root cause analyses and facilitated cross-functional complaint reviews.
- Implemented MBSE practices to link requirements and design system architecture — the company’s first adoption of MBSE.
- Developed the internal requirements engineering process to align with FDA design controls.
- Mentored interns, assigned projects, and reviewed deliverables to build organizational capability.
Intern
Terumo BCT
Lakewood, Colorado
06.2012 - 08.2012
- Generated requirements based on a statistical analysis of system test results.
- Managed early FMEA activities and performed bioreactor scaling studies (10× and 100× volume).
Education
Master of Engineering - Biomedical Engineering
Rutgers University
New Brunswick, NJ01-2019
Bachelor of Science - Chemical And Biological Engineering
University of Colorado At Boulder
Boulder, CO05-2012
Skills
- Model-based systems engineering
- SysML proficiency
- Regulatory compliance
- Cross-functional collaboration
- Effective communication
- Problem solving
- Leadership skills
- Training program development
Certification
- OMG Accredited Training Provider (Issued: May 2025)
- Certified Systems Engineering Professional (CSEP) (Issued: June 2024)
- OMG-Certified Systems Modeling - Model Builder (Issued: Jan 2023)
- OMG-Certified Systems Modeling - Model User (Issued: Sep 2022)
- Kepner Tregoe - Problem Solving and Decision Making (Issued: May 2014)
References
References available upon request.
Timeline
Director of Product Development
Studio SE, Ltd
08.2023 - Current
Principal Trainer
Studio SE, Ltd
08.2022 - 08.2023
Associate Director of Process Development
Atsena Therapeutics
02.2022 - 08.2022
Process Engineer 3
Precision Biosciences
05.2021 - 02.2022
Process Engineer 2
Precision Biosciences
04.2019 - 05.2021
Process Engineer 1
Precision Biosciences
04.2017 - 05.2019
Systems Engineer 2
Terumo BCT
06.2013 - 04.2017
Systems Engineer 1
Terumo BCT
09.2012 - 07.2013
Intern
Terumo BCT
06.2012 - 08.2012
Master of Engineering - Biomedical Engineering
Rutgers University
Bachelor of Science - Chemical And Biological Engineering
University of Colorado At Boulder
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