Maryam Ropp
Clinical Research Scientist & Laboratory Manager @Rise Therapeutics
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WORK HISTORY
Clinical Research Scientist & Laboratory Manager @Rise Therapeutics
US
Advanced Research & Development: Lead complex scientific initiatives in diagnostics and oncology drug development, conducting in vitro and in vivo assays using human blood samples to evaluate efficacy, safety, and biological response across multiple therapeutic programs•Molecular & Cellular Analysis: Perform high-precision DNA/RNA extraction, bacterial characterization, flow cytometry (FACS), qPCR, ELISA, and PBMC analysis to generate robust, reproducible data supporting preclinical and translational research•Laboratory Operations Management: Direct all aspects of day-to-day laboratory operations, ensuring seamless workflow integration and strict adherence to GMP, GLP, and CLIA regulatory standards across research sites•Analytical Method Development: Design, validate, and implement advanced reference standard methodologies, establishing reproducible systems that enhance analytical precision and regulatory readiness•Quality Systems Leadership: Develop and enforce comprehensive QC and QA protocols that strengthen data integrity, promote traceability, and ensure compliance with evolving regulatory and inspection requirements•Manufacturing & Analytical Testing: Oversee manufacturing and analytical testing functions supporting clinical and preclinical studies, ensuring timely delivery of high-quality, compliant data packages for submission•Regulatory & Documentation Excellence: Author and critically review protocols, SOPs, and IND submissions for FDA-regulated research, facilitating alignment with global clinical and regulatory expectations•Training & Biosafety Leadership: Mentor, train, and evaluate staff in biosafety practices, risk assessment, and hazard control, building a culture of safety, accountability, and scientific excellence across all research teams
EDUCATION
University of Maryland Eastern Shore
Doctor of Philosophy (PhD), Toxicology
ABOUT MARYAM ROPP
Accomplished Clinical Research Scientist and Laboratory Manager with extensive experience in diagnostics, oncology, and drug development, combining scientific rigor with operational excellence across regulated laboratory environments. Skilled in leading in vitro and in vivo studies, DNA/RNA extraction, qPCR, ELISA, and flow cytometry, with a strong record managing GMP/GLP/CLIA-compliant facilities and supporting IND and Phase I clinical studies. Experienced in designing experiments that drive clear decisions, troubleshooting complex data, and communicating results across cross-functional teams. Known for developing assays, authoring protocols and SOPs, and implementing QC/QA systems that strengthen data integrity and regulatory compliance. Demonstrated success in biosafety and risk assessment (BSL-2, BSL-3), vendor negotiation, procurement strategy, and resource optimization in fast-paced environments. Brings expertise in mammalian and bacterial cell culture, HPLC analysis, and cell therapy applications including expansion, isolation, and storage, with a proven history advancing oncology research and mentoring teams to achieve scientific and operational excellence.SKILLSClinical Research Scientist, Laboratory Manager, Trial Operations, Molecular and Cellular Biology, GMP/GLP/CLIA Compliance, Quality Assurance and Regulatory Documentation, FDA Submissions (SOPs, INDs), Data Analysis and Validation, Biosafety and Risk Management (BSL-2, BSL-3), Cross-Functional Team Leadership, Process Improvement and Cost Control, Flow Cytometry (FACS), qPCR, ELISA, IND Applications and Clinical Trial Support, Mammalian and Bacterial Cell Culture, Assay Development, DNA/RNA Extraction, Protocol Development (SOPs, QC/QA), In Vitro and In Vivo Studies, Cell Therapy (Expansion, Isolation, Storage)
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