Senior Leader
Highly Technical
CMC Strategist
Problem Solver
Cross-Functional Collaborater
Emily Sciortino
Accomplished biopharmaceutical analytical development and quality control leader with 15 years’ experience driving end to end analytical control strategy, method development, validation and regulatory submission activities for biologics. Extensive experience overseeing CMC analytical work across early and late-stage development for various modalities including monoclonal antibodies, complex fusion proteins and bispecifics. Well-versed with internal and external global QC network management, including CDMO and CLO relationships, method/technology transfers, and ensuring GxP compliance. My passion is transforming drug development using automation tools and platform methodologies to support efficient, high-quality analytical execution.
What I Do
Chemist & Biochemist
Deep expertise in analytical method development of biologics including monoclonal antibodies, fusion proteins, and other complex modalities. Highly skilled in applying structure-function insights to support drug development, comparability and control strategies.
Senior Leader
Overseeing a team of 30+ direct and indirect reports supporting analytical method development and process support for biologics. Proven track record of building high performing teams, driving scientific strategy, and enabling robust program development across modalities through strong cross-functional collaboration.
CMC Analytical Lead
Experienced CMC analytical lead guiding programs from early clinical development through commercialization and post-market support. Expert in establishing phase-appropriate strategies, control systems, and regulatory submissions to ensure analytical readiness across the product lifecycle.
Method Development
Leader in analytical method development spanning physico-chemical, bioassay, and automation platforms. Known for driving innovation and implementing cutting edge technologies and strategies to enhance assay performance, throughput and scientific rigor across biologics portfolio.
Professional Endorsements

Samantha Cote

Joseph Zeskand