Edward Ciolkowski, Ph.D., joined Syner-G in 2014 as an expert in Small Molecule CMC Development. Ed has 30+ years’ experience as a biotech leader and professional pharmaceutical scientist with a background in directing multi-functional teams. He is skilled at creating new and adapting existing organizational capabilities to align with growing business needs and enhancing business effectiveness.

Ed is a quality-minded leader, scientist, and motivational project leader with the ability to integrate a broad range of perspectives and align a team around a unified strategy. He is comfortable with complexity and ambiguity and is both science-oriented and business-focused. He believes in mentorship and cross-functional teamwork and routinely collaborates with Regulatory, Quality, and Operation organizations to drive alignment and governance.

His previous work experience includes The Upjohn Company, Pharmacia, Pfizer, and Bausch and Lomb, where he gained expertise in science-driven CMC regulatory strategies. He has technical expertise in drug substance and drug product development, manufacturing process development and scale-up, biopharmaceutics, and in-vitro product performance testing. He is also knowledgeable in Quality-by-Design (QbD), nitrosamine risk assessments, comparability assessments, determination of critical quality attributes for starting materials and products, and clinical supply chain management. Ed’s product development and regulatory expertise includes the solid-oral, sterile, topical, ophthalmic, and veterinary space and ranges from pre-IND through product registration and post-approval change phases.

He received a Bachelor of Arts in Chemistry from Wabash College and Doctor of Philosophy in analytical chemistry from the University of North Carolina Chapel Hill. He has contributed to over 50 global regulatory submissions, 20 product launches, numerous filings, and 9 scientific articles.