Kristyn Greco

About Kristyn Greco

I am a biotech/pharmaceutical leader with 15+ years of experience spanning R&D, late-stage development, commercial operations, and quality. My career has been built at the intersection of science and operations—leading teams that ensure product quality, regulatory compliance, and operational excellence across global markets.Currently, I serve as Executive Director at Regeneron, leading a 200+ person organization responsible for quality control investigations, and support functions, as well as oversight of commercial ELISA and bioassay laboratories. I am passionate about building high-performing teams, driving modernization initiatives, and embedding a culture of continuous improvement that accelerates speed, compliance, and scientific rigor.Highlights of my career include: • Led multiple commercial laboratories which consistently met test on time and quality metrics and exceeded performance standards. Labs incorporated operational excellence with scientific method improvements to drive operations in the quality control unit. • Successfully reducing QC investigation backlogs by >70%, significantly improving compliance and operational flow. • Spearheading automation in bioassays to reduce human error and strengthen data integrity. • Direct engagement with global health authorities during inspections and regulatory submissions (BLA, MAA). Experienced in authoring BLA, MAA sections for filings. • Holding 3 patents and authoring multiple peer-reviewed publications in pharmaceutical sciences.I am motivated by solving complex problems, leading through change, and ensuring that innovation in biologics is matched with uncompromising quality standards.

Experience

1. Executive Director, Qc Investigations, Support and Biology

   Regeneron

   Jan 2025 — Present

   I lead multiple support teams in QC including QC investigations, equipment, reference standards, critical materials, change control, sample management, stability, data reporting and monitoring. In addition, I lead the ELISA and bioassay laboratories. I am currently spending time working on organization-wide quality and modernization initiatives.

Education

• Northeastern University

  BS, Chemical Engineering

• University of Connecticut

  Ph.D. Pharmaceutical Sciences