Cell Therapy Process Development Scientist

Teresa Staab

Senior Cell Therapy & Process Development Scientist

*******@*******.*** • 410-***-****

linkedin.com/in/terri-staab-7b8963287 • Parkville, MD 21234

Scientifically rigorous and results-driven professional with deep expertise in cell culture systems, bioprocess scalability, and scientific leadership across clinical and biopharmaceutical environments.

Track record of driving end-to-end cell therapy process development, optimizing cell culture workflows, troubleshooting complex bioprocess and instrumentation challenges, and ensuring seamless technology transfer across client programs. Well-versed in advancing manufacturing readiness through rigorous process validation, cross-functional coordination, and direct client technical engagement in GMP-aligned environments. Recognized for mentoring laboratory teams, leading subject matter expert initiatives, and contributing to peer-reviewed research in adoptive cell therapy and automated formulation and fill systems.

Areas of Expertise

Bioprocess Scale-Up

Aseptic Technique Execution

Cell Separation Technologies

Instrumentation Troubleshooting

Client Program Onboarding

Bioreactor Systems Operation

Formulation & Fill Operations

Regulatory Compliance Adherence

Experimental Data Analysis

Scientific Team Mentorship

Laboratory Quality Assurance

Gene Therapy Manufacturing

Professional Experience

Charles River Laboratories, Hanover, MD 2021 – 2026

Process Development Scientist

Drive consistent and scalable cell culture processes by harvesting cells, maintaining multiple cell lines, and performing precise cell counts using automated cell counting systems under strict aseptic conditions. Ensure uninterrupted laboratory and manufacturing support by maintaining, calibrating, and troubleshooting critical instruments and equipment used in cell culture and process development activities. Support efficient bioprocess development and scale-up by applying expertise in cell separation systems, cell expansion platforms, bioreactors, formulation and fill operations, and technology transfer processes.

Key Contributions:

●Enabled successful onboarding of new client programs by evaluating and validating new instrumentation, ensuring compatibility with existing workflows and client process requirements.

●Accelerated manufacturing readiness and team capability by serving as subject matter expert for process and manufacturing training, supporting knowledge transfer and operational consistency.

●Minimized process disruptions and improved operational reliability by diagnosing and resolving complex process and equipment-related issues within cell culture and bioprocess systems.

●Strengthened team productivity and scientific output by supervising and mentoring two scientists while coordinating daily laboratory and project activities.

●Improved data-driven decision making and process documentation by analyzing experimental and operational data and generating detailed process reports using tools such as Microsoft Office and Prism.

Cognate Bioservices, Hanover, MD 2015 – 2021

Research Associate Process Development

Ensured regulatory and laboratory safety compliance by maintaining current Safety Data Sheets (SDS) and reinforcing adherence to established safety and handling protocols. Supported integration of new client programs and technologies by assessing and validating new instrumentation for compatibility with existing process development workflows.

Key Contributions:

●Improved consistency and viability of tumor cell culture processes by executing cell harvesting, maintaining tumor cell lines, and performing accurate cell counts using automated cell counting systems under controlled aseptic conditions.

●Sustained reliable laboratory and process development operations by maintaining, calibrating, and troubleshooting critical laboratory instruments and equipment used in cell culture workflows.

●Maintained uninterrupted laboratory operations and material readiness by managing inventory levels, monitoring supply usage, and coordinating timely procurement of critical laboratory materials.

●Strengthened technical support for cell therapy process development activities by applying expertise in aseptic technique, automated cell counting technologies, cell separation systems, and cell expansion platforms.

University of Maryland Upper Chesapeake Medical Center, Bel Air, MD 2006 – 2021

Chemistry/Core Lab

Maintained reliable core laboratory operations and minimized instrument downtime by performing routine maintenance, calibration, and troubleshooting of analytical instrumentation. Ensured specimen integrity and efficient laboratory workflow by coordinating specimen processing, verification, and preparation for accurate downstream testing. Supported high-quality clinical diagnostics by applying technical expertise in chemiluminescent immunoassays, high-performance liquid chromatography (HPLC), nephelometry, turbidimetric assays, and agglutination methodologies used in core laboratory testing.

Key Contributions:

●Delivered accurate and timely clinical chemistry results to support physician decision-making and patient care by performing complex patient testing, including therapeutic drug monitoring, hepatitis assays, and diabetes-related testing in high-volume hospital core laboratory.

●Strengthened laboratory quality and regulatory compliance by supporting quality assurance initiatives and ensuring testing procedures aligned with established clinical laboratory standards.

●Expanded diagnostic testing capability and laboratory efficiency by evaluating, validating, and implementing new analytical methods and instrumentation within the chemistry/core lab environment.

●Enhanced laboratory team performance and operational consistency by training and mentoring new employees and students on testing methodologies, laboratory procedures, and equipment operation.

Additional Experience

●Toxicology/Special Chemistry/Hematology/Core Lab, Johns Hopkins Hospital, Baltimore, MD

●EMT-B, Abingdon Fire Company, Abingdon, MD

Education

Bachelor of Science – University of Delaware, Newark, DE

Crime Scene Investigator Certification – University of Maryland Global Campus, Adelphi, MD

American Society of Clinical Pathologists, Certification Maintenance Program

American Society for Cell and Gene Therapy, 2024 – 2025

Publications

●Pleitez D, Park M, Safford M, Scheers J, Hammill L, Jerbi T, Koudji E, Yelity S, Campion S, Werner S, Sargent A. Cryopreserving CAR-T cells in a novel rigid container maintains their phenotype and function compared to conventional cryobags and cryovials. Cell & Gene Therapy Insights. 2024 August 20; 10(7), 968-980.

●Park M, Safford M, Scheers J, Hamill L, Pleitez D, Jerbi T, Koudji M, Yelity S, Campion S, Miller M, Gibb S, Sargent A. Automation preserves product consistency and quality for the formulation, fill, and finish of T cell-based therapies. Cytotherapy. 2024 July 11; S1465-3249(24)00798-9.

●Lee E, Safford M, Staab T, Park M, Ryan M, Pleitez D, Sargent A. Automating CAR T cell Across Distinct Platforms Delivers Similar Cell Quality, Phenotype, and Function. Cytotherapy. 2026 August 05

Conference Presentations

●Safford M, Jendusa J, Park MS, Staab T, Pleitez D, Koudji M, Yelity S, Sargent A. Scaling CAR-T Manufacturing: Redefining Large Volume Fill-Finish with the ARES X20+ Automation. ASGCT (Poster), 2025.

●Marcelle K, Jerbi T, Sargent A. Novel Experimental Approach to Improve Scale-up of Microcarrier-based Cell Culture in Bioreactors. ASGCT (Poster), 2024.

●Park M, Safford M, Scheers J, Hammill L, Pleitez D, Jerbi T, Koudji M, Yelity S, Campion S, Miller M, Gibb S, Sargent A. Closed Automation Enables Quick Fill-Finish of Large-Scale T Cell Therapy While Maintaining Consistency and Quality of the Final Product. ASGCT (Poster), 2024.

Patents

Pleitez D, Jerbi T, Scheers J, Campion S, Noffsinger L, Hewitt M, Sargent A. Method for improving genetic engineering of adoptive cell therapies. U.S. Patent Appl. No. 63/488,354.

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