Research Scientist Molecular Biology

KATHERINE BORTOFF, PhD

Raleigh, NC 919-***-**** ********@*****.*** linkedin.com/in/kathy-bortoff RESEARCH SCIENTIST – CARDIAC REGENERATION & MOLECULAR BIOLOGY Driving rigorous, creative, and collaborative science to advance regenerative medicine PROFESSIONAL SUMMARY

Scientist and laboratory leader with 20+ years bridging academic discovery and regulated biopharma environments. Expertise in molecular and cellular biology, gene and protein expression, and RNA analysis, with deep experience designing, executing, and interpreting experiments in compliance with quality and ethical standards. Recognized for building efficient, high-functioning labs, mentoring diverse teams, and translating complex data into actionable insight. CORE STRENGTHS

Cellular & Molecular Biology Gene Editing (ARCUS, Cloning) RNA/Protein Analysis Mammalian Cell Culture

Experimental Design Literature Review & Data Interpretation Method Development Staff Training Lab Operations Compliance & Documentation Scientific Communication SELECTED ACHIEVEMENTS

• Advanced CAR T therapy through data-driven experimentation – designed and optimized molecular assays supporting CAR T manufacture; improved signal reproducibility >30% through standardized templates and QC checkpoints.

• Bridged research and compliance – maintained 100% audit-ready documentation under GLP/GMP standards while supporting exploratory biology projects; authored protocols, validation reports, and deviation assessments.

• Mentored and cross-trained scientists and students – created training modules for qPCR, ELISA, and mammalian cell culture that increased independent competency and reduced rework by 40%. PROFESSIONAL EXPERIENCE

IQVIA Inc. – Durham, NC

Senior Scientist, Reagents 2024 – 2025

Led QC reagent operations supporting global clinical and analytical programs.

• Increased inventory accuracy 40% and project completion 25% by centralizing reagent tracking (LabVantage, Smartsheet).

• Reduced shipment errors by 20% with standardized SOPs for cold-chain logistics.

• Delivered 100% audit-ready documentation via ZenQMS and GDP training. Imugene Ltd. / Precision BioSciences – Durham, NC

Scientist II, Analytical Sciences & Technology / CMC 2020 – 2024 Directed analytical operations supporting CAR-T and viral vector programs.

• Increased analytical throughput 45% via standardized method transfer and bridging protocols.

• Reduced stability deviations by 35% through CAPA governance and variability control.

• Authored validation reports, CoAs, and PQS documentation with zero audit findings.

• Mentored staff across QC and CRO teams; enhanced collaboration using behavioral-based training methods. BioAgilytix Labs – Durham, NC

Scientist III 2013 – 2020

Managed bioanalytical studies for biologics and cell/gene therapy programs.

• Achieved 100% regulatory acceptance for validated ELISA and potency assays.

• Improved turnaround time 25% through optimized scheduling and automation.

• Supported FDA and EMA inspections; implemented visual data systems to flag trending deviations. Earlier Roles – Research Associate / Laboratory Manager Raleigh / Durham, NY Developed and optimized assays for protein expression, cellular signaling, and genetic modulation. Provided mentorship to junior researchers, authored SOPs, and coordinated collaborative studies across departments. EDUCATION

PhD, Physiology / Cell and Molecular Biology – Syracuse University BS, In Vitro Cell Biology and Biotechnology – SUNY Plattsburgh CRA Certificate – Fundamentals of Clinical Research, GCP & ICH Guidelines TECHNICAL SYSTEMS

LabVantage Smartsheet ZenQMS GraphPad Prism JMP MSD qPCR/ddPCR ELISA Flow Cytometry Hamilton

Gen5 SnapGene SoftMax Microsoft 365 Windows / Mac OS Result: Duke gains a scientist who blends experimental depth with mentorship and operational excellence—someone ready to accelerate discovery in cardiac regeneration by uniting molecular insight, quality discipline, and a collaborative research spirit.

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