SHANNON ROSELLI
Marlborough,MA
Summary
Accomplished Senior Quality Control Analyst with 4+ years of biotechnology experience specializing in T-cell receptor (TCR-T) therapies and cell-based therapeutics under strict cGMP regulations. Proven track record overseeing QC cellular biology laboratory operations, mentoring technical staff, and ensuring absolute data integrity. Recognized Subject Matter Expert (SME) in advanced multi-color flow cytometry methodologies and cell-based potency assays. Adept at managing complex OOS/OOT investigations via Veeva and STEEL LIMS, executing seamless method transfers, and driving continuous laboratory improvements to meet tight clinical production timelines.
Overview
5
5
years of professional experience
Work History
Senior Quality Control Analyst
TScan Therapeutics
06.2026 - Current
- Technical Subject Matter Expertise: Serve as the designated QC Subject Matter Expert (SME) for all flow cytometry methods and cell-based potency assays, providing advanced technical troubleshooting, protocol optimization, and cross-functional guidance.
- Method Implementation: Led the tech transfer, qualification, optimization, and validation of all QC analytical methods necessary to support cellular drug product release.
- Final Data Approval & Compliance: Serves as the authority for reviewing and approving analytical data and QC documentation generated by team members to guarantee complete data integrity.
- Advanced Compliance Ownership: Direct the tracking, trending, and timely resolution of critical OOS/OOT results, laboratory deviations, CAPAs, and change controls partnering with QA on complex root-cause analyses and improved process development.
- Strategic Cross-Functional Leadership: Partner directly across Quality Assurance, Process Development, Manufacturing, and Facilities to align critical clinical testing timelines and drive continuous laboratory improvements.
- Technical Writing: Author and revise high-level GMP documentation, including validation protocols, technical reports, and master SOPs.
- Personnel Development: Act as a technical mentor by designing and executing training and qualification programs for junior analyst staff.
Quality Control Analyst
TScan Therapeutics
06.2024 - 06.2026
- cGMP Product Testing: Performed cGMP bio-analytical release and in-process testing for cellular drug products, utilizing advanced methodologies including multi-color Flow Cytometry, luciferase-based potency assays, vector number copy ddPCR, transgene expression ddPCR, cell count and viability, and visual inspection/appearance for drug product release.
- Microbiology & Safety: Conducted microbiological and compendial sterility testing in strict compliance with standard operating procedures (SOPs).
- Documentation & Data Review: Generated and updated laboratory records, forms, and data sheets, while reviewing QC documentation to ensure baseline accuracy and consistency.
- Method Support: Assisted in the hands-on execution of test method validation and optimization protocols under defined regulatory parameters.
- Deviation Resolution: Participated in timely laboratory deviation investigations and CAPA troubleshooting workflows to maintain cleanroom operational efficiency.
- Sample & Inventory Control: Assisted in laboratory maintenance, custody, and ensured control of QC test samples, reference standards, reagents, and stability retains met compliance.
- Laboratory Stewardship: Managed daily, weekly, and monthly maintenance and equipment upkeep schedules for the QC and Microbiology laboratories.
Research Associate in Cellular Therapies and Bioanalytics
Sanofi
Framingham, Massachusetts
08.2022 - 06.2024
- Performed comprehensive cell-based and flow-based assays to assess cellular characteristics at various process stages.
- Conducted multi-colored flow cytometry assays to identify monocytes, B cells, T cells, granulocytes, NK cells, and NKT cells in incoming apheresis material.
- Lead and support internal assay tech transfers from analytical development teams
- Executed independent GMP testing during PM shifts, ensuring strict compliance with regulations.
- Collaborated with manufacturing, release, and testing teams to ensure timely management of test deliverables and training activities.
- Managed analytical databases and performed data analysis to enhance assay performance.
- Managed analytical databases to ensure data integrity and accessibility for team members. such as STEEL LIMS and performed data analysis to support assay performance and control
- Developed tracking and trending tools to monitor assay control performance metrics effectively.
- Maintained cGMP compliance with documentation requirements while managing analytical infrastructure.
- Used VEEVA to initiate deviations, CAPAs, ILL, OOT and OOS
- Mentored junior staff on proper laboratory procedures and techniques, fostering skill development.
- Authored SOPs and technical documentation, contributing to clarity and compliance of operational procedures.
Researcher
Dr. Chen's Lab
Durham, NH
01.2022 - 05.2022
- Conducted research on primary cilia in mouse brains with a PhD mentor to investigate neurological implications
- Analyzed CA1 region of hippocampus in double knockout mice lacking AC1 and AC8 genes to enhance understanding of gene function
- Executed immunohistochemistry, utilizing AC3 and Arl13B antibodies, preparing brain tissue and slicing samples with a cryostat, while performing mouse genotyping and conducting confocal imaging
Education
Bachelor of Science - Biochemistry, Molecular And Cellular Biology
University of New Hampshire
Durham, NH05-2022
Skills
- QC Assays & Molecular Biology (SME Focus): Subject Matter Expert in Multi-color Flow Cytometry & Cell-Based Potency Methods; highly proficient in immunophenotyping, cellular characterization, co-culture systems, reporter gene assays (luciferase-based), qPCR, ddPCR, ELISA, cell-counting protocols, sterility testing, and endotoxin assays
- cGMP Compliance & Operations: cGMP regulatory standards, Data Integrity review, QA practices, risk assessments, deviation management, OOS/OOT assessments, CAPA implementation, root-cause analysis, environmental monitoring (viable/non-viable), cleanroom operations
- Software & Systems: Veeva Vault, Steel LIMS, analytical databases, data tracking & trending tools, Microsoft excel, Microsoft word, Microsoft PowerPoint
- Leadership & Technical Writing: SOP development & revision, protocol generation, validation reports, staff training & qualification initiatives, technical mentoring, cross-functional technical communication
- Foundational Methodologies: Gas chromatography, gel electrophoresis, solvent extraction, light microscopy, experimental design, quantitative data analysis
Timeline
Senior Quality Control Analyst
TScan Therapeutics
06.2026 - Current
Quality Control Analyst
TScan Therapeutics
06.2024 - 06.2026
Research Associate in Cellular Therapies and Bioanalytics
Sanofi
08.2022 - 06.2024
Researcher
Dr. Chen's Lab
01.2022 - 05.2022
Bachelor of Science - Biochemistry, Molecular And Cellular Biology
University of New Hampshire