William Matousek
Associate Director | Biopharmaceutical Research & Development | CMC Strategy | Driving Innovation from Discovery through Commercialization
- Role
- Associate Director R & d Product Biochemistry at Regeneron
- Location
- Tarrytown, NY, US
- LinkedIn followers
- 500 followers
About William Matousek
Accomplished scientific leader with over 15 years of experience in Chemistry, Manufacturing, and Controls (CMC), specializing in biologics, siRNA therapeutics, and advanced analytical methods. Recognized for pioneering advancements in Quality by Design (QbD) strategies, establishing Nuclear Magnetic Resonance (NMR) as a core capability, and delivering innovative solutions for late-stage development and regulatory submissions. Proven ability to lead cross-functional teams, implement infrastructure improvements, and drive high-impact programs from development to commercialization. Adept at fostering collaboration, mentoring talent, and aligning scientific innovation with organizational goals.
Experience
Associate Director R & d Product Biochemistry
Jan 2022 — Present · Tarrytown, NY, US
Directed CMC activities for late-stage and commercial programs, including Cemdisiran, Regeneron’s first siRNA product, delivering in-house extended characterization and regulatory filings. Led QbD informed AAV analytical method development activities enabling commercialization of Regeneron\'s gene therapy portfolio: Advanced NMR methodologies for ADC payloads, cyclic peptide constructs, and siRNA modification verification, positioning Regeneron as a leader in cutting-edge analytical techniques: Spearheaded IT projects, including SDMS and Empower implementation, streamlining data management and enhancing operational efficiency: Partnered with pre-clinical manufacturing, analytical sciences, and regulatory teams to align scientific objectives with business priorities: Cultivated a high-performing team, fostering technical expertise and leadership growth among direct reports.
Education
University of Connecticut
PhD, Biophysics and Structural Biology
Albert Einstein College of Medicine
Postdoctoral Research
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