Cindy Yueli Chen

About Cindy Yueli Chen

I am a scientist with a strong background in method development, pharmaceutical quality control, and regulatory compliance. My expertise spans small molecule and biologics drug development, with a focus on analytical characterization, stability studies, and process optimization to support pharmaceutical manufacturing and product lifecycle management.Throughout my career, I have worked in cross-functional teams to develop, validate, and transfer robust analytical methods that ensure drug product integrity and regulatory compliance. My experience includes working within GMP, GLP, ICH, and USP guidelines, conducting investigations into Out-of-Specification (OOS) and Out-of-Expectation (OOE) results, and optimizing drug product compatibility in primary packaging systems. I have also collaborated with quality control, R&D, and regulatory teams to resolve technical challenges and streamline analytical processes.Beyond laboratory work, I have a deep interest in process analytical technology (PAT) and its role in real-time monitoring and quality control. My work in biologics packaging characterization and small molecule analytical development has allowed me to contribute to scientific publications and research advancements that drive innovation in pharmaceutical development.I believe in continuous learning and collaboration, and I enjoy working in environments that challenge me to think critically and refine analytical strategies. My approach is always data-driven, solutions-oriented, and focused on maintaining the highest quality standards in pharmaceutical research.I am always open to discussing new advancements in analytical sciences, pharmaceutical quality, and emerging technologies in drug development.

Experience

1. Senior Scientist

   Evonik

   Jul 2025 — Present

Education

• Stony Brook University

  Bachelor of Science - BS, Chemistry

  2016 — 2018

• University of Pennsylvania

  Doctor of Philosophy - PhD, Chemistry

  2018 — 2023

• Queensborough Community College of The City University of New York (CUNY)

  AA, Liberal Arts and Sciences/Liberal Studies

  2013 — 2016