Summary
Overview
Work History
Education
Professional Skills
Certifications and Awards
Publications and Patents
Timeline
Generic

Xuedi Yu

Cambridge,MA

Summary

  • 7 Years of work experience in the biotechnology and pharmaceutical industry, experienced with drug product formulation and chemical process development for investigational drug substances, familiar with GLP and GMP regulations.
  • Strong background in material science and analytical chemistry. Rich hands-on experience in laboratory bench works with varied skill sets in formulation, characterization, and synthesis.
  • Experienced in utilizing machine learning algorithms and in silico approaches to predict the properties and performance of drug formulations.
  • Strong problem-solving and troubleshooting skills and extensive experience in the design of experiments (DoE)
  • Experienced in writing patents, papers, method reports, and standard operating procedures (SOPs) based on ASTM/ISO standards and FDA guidance, such as ICH M9 and M7
  • Excellent oral communication skills. Initiative to work independently and collaboratively.

Overview

7
7
years of professional experience

Work History

Research Investigator CMC

Takeda Pharmaceuticals
01.2024 - Current
  • Designed and executed in-vitro characterization and biopharmaceutics evaluations of drug candidates to assess formulation performance and facilitate drug candidate selection
  • Developed and implemented in silico models and simulations to predict the properties and in vivo performance of drug formulations, supporting drug formulation development and selection.
  • Characterized physical and chemical properties of material with analytical instruments, such as DSC, TGA, pXRD, etc.
  • Responsible for designing and preparing formulations for in-vivo studies.
  • Collaborated with cross-functional teams, interpreting and reviewing experimental data to draw robust conclusions

Scientist III

Eurofins Scientific
01.2021 - Current

Supporting Formulation and Chemical Process Development at Biogen Inc

  • Designed and executed studies on new development candidates to assess formulation performance in vitro, elucidate fundamental physicochemical properties and behaviors that enable lead candidate selection
  • Developed analytical methods, validation and in-process testing, for small molecule drug substances and prototype formulations.
  • In house synthesized impurity markers and developed control strategies for DNA reactive (mutagenic) impurities for early phase programs.
  • Performed statistical analysis of experimental data. Interpret data to form sound conclusions and performed experimental troubleshooting routinely.
  • Collaborated closely with cross-functional teams to provide biopharmaceutics risk assessment and support formulation development.

Research Scientist

Aleo BME, Inc.
12.2017 - 01.2021
  • Led all aspects of the design and conducted formulation development for two projects that resulted in a non-provisional patent.
  • Developed ex vivo model reproducing the environment close to thehuman gastrointestinal tract(GI tract) and performed ex vivo tests for product performance evaluation.
  • Responsible for physical and chemical characterizations, including HPLC, NMR, FTIR and rheometer, etc.
  • Generated internal lab test protocols, critical project reports, and SOPs based on ASTM and ISO standards, and contributed to patent applications.
  • Supervised and trained company technicians in critical lab procedures, method standardization, GLP and GMP practices, and proper documentation of results.

Education

Master of Science - Applied Biomedical Engineering

Johns Hopkins University
Baltimore
05.2023

Bachelor of Science - Material Science and Engineering

Pennsylvania State University
State College, PA
05.2017

Professional Skills

Formulation Bridging: In vitro Dissolution Studies, TNO Gastro-Intestinal Model(TIM), Solubility Test, Stability Test, Physiologically-Based Biopharmaceutics Modeling (PBBM)

Characterization: High Performance Liquid Chromatography (HPLC). Gas Chromatography (GC), Mass spectrometry (MS), Nuclear Magnetic Resonance spectroscopy (NMR), Fourier-transform infrared spectroscopy (FTIR), Scanning Electron Microscope (SEM), Differential Scanning Calorimetry (DSC), Thermogravimetric Analysis (TGA), Karl Fischer (KF)

Softwares: GastroPlus, Phoenix WinNonline, LIMS, Python, Matlab, and Microsoft Software

Certifications and Awards

  • IASSC certified Lean Six Sigma Green Belt
  • Internal scholarship from Pennsylvania State University - Department of Material Science and Engineering
  • Excellence award for Materials Engineering Methodology and Design Competition

Publications and Patents

Yu, X., Liu, C., Ma, C., Compositions Comprising Fluid Gels for Tissue Separation. 17/211,037, (Mar 24, 2021, patent pending)

Yu, X., Solid Polymer Electrolyte Water Electrolysis Systems for Hydrogen Production. ZL 201721128762.5 (Mar 30, 2018, granted)

Zhu, L., Yu, X., Peng, X., Zimudzi, T. J., Saikia, N., Kwasny, M. T.,… Hickner, M. A. (2019).Poly(olefin)-Based Anion Exchange Membranes Prepared Using Ziegler–Natta Polymerization.Macromolecules, 52(11), 4030-4041.

Zhu, L., Peng, S., Shang, S., Kwasny, M., Zimudzi, T. J., Yu, X.,… Hickner, M. A. (2019) HighPerformance Anion Exchange Membrane Fuel Cells Enabled by Fluoropoly(Olefin) Membranes.Advanced Functional Materials 29 (26): 1902059.

Zhu, L., Yu, X., Hickner, M. A.. (2018). Exploring backbone-cation alkyl spacers for multi-cationside chain anion exchange membranes. Journal of Power Sources, 375, 433-441.

Zhu, L., Zimudzi, T. J., Wang, Y., Yu, X.,… Hickner, M. A (2017) Mechanically robust anion exchange membranes via long hydrophilic cross-linkers,Macromolecules, 50, 2329–2337

Timeline

Research Investigator CMC

Takeda Pharmaceuticals
01.2024 - Current

Scientist III

Eurofins Scientific
01.2021 - Current

Research Scientist

Aleo BME, Inc.
12.2017 - 01.2021

Master of Science - Applied Biomedical Engineering

Johns Hopkins University

Bachelor of Science - Material Science and Engineering

Pennsylvania State University

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