Zhe Li Email & Phone Number | 2+ years of research experience in continuous quality improvement within different manufacturing environments, with specific focus on the formulation optimization aiming at developing a comprehensive optimization procedure incorporating appropriate design of experiments (DOE) and evaluation techniques for new tablets while all related regulatory requirements are satisfied. Project Overview: A corporate project concerning drug reliability •Reviewed drug development process, biopharmaceutical supports, involved analytical methodologies, and associated current good manufacturing practice (cGMP) regulations •Categorized drug recalls •Summarized recalls statistics and potential reasons Project Overview: A project regarding pharmaceutical Quality by Design (QbD) •Investigated flows and elements of QbD in pharmaceutical industry •Studied pharmaceutical formulation optimization under the system of QbD Dedicated to modeling and optimizing pharmaceutical formulations when scale-up changes occur: •Studied and became familiar with the Food and Drug Administration (FDA) and United States Pharmacopeia (USP) regulations on formulation development •Conducted literature review •Created experimental designs •Simulated and collected data •Completed data analysis •Proposed mathematical models for pharmaceutical formulation optimization incorporating all possible regulatory requirements •Compared solutions resulting from traditional and proposed methods

Zhe Li

2+ years of research experience in continuous quality improvement within different manufacturing env...
Central, South Carolina, United States

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Zhe Li’s Email zhel@clemson.edu

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Zhe Li’s Location Central, South Carolina, United States

Zhe Li’s Current Industry Clemson University

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2010-01-01 00:00:00 - Present

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Zhe Li is a 2+ years of research experience in continuous quality improvement within different manufacturing environments, with specific focus on the formulation optimization aiming at developing a comprehensive optimization procedure incorporating appropriate design of experiments (DOE) and evaluation techniques for new tablets while all related regulatory requirements are satisfied. Project Overview: A corporate project concerning drug reliability •Reviewed drug development process, biopharmaceutical supports, involved analytical methodologies, and associated current good manufacturing practice (cGMP) regulations •Categorized drug recalls •Summarized recalls statistics and potential reasons Project Overview: A project regarding pharmaceutical Quality by Design (QbD) •Investigated flows and elements of QbD in pharmaceutical industry •Studied pharmaceutical formulation optimization under the system of QbD Dedicated to modeling and optimizing pharmaceutical formulations when scale-up changes occur: •Studied and became familiar with the Food and Drug Administration (FDA) and United States Pharmacopeia (USP) regulations on formulation development •Conducted literature review •Created experimental designs •Simulated and collected data •Completed data analysis •Proposed mathematical models for pharmaceutical formulation optimization incorporating all possible regulatory requirements •Compared solutions resulting from traditional and proposed methods