Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Rui-Yang Zhang

Trappe,PA

Summary

  • Ph.D. Biochemist with over 5 years of industry experience in analytical development and characterization, including direct experience in bioconjugation development and process optimization.
  • Proven leader in analytical characterization (LC-MS, HPLC) of conjugate products and method development/validation under GxP principles.
  • Skilled in process development analytical support, technical problem-solving, and tech transfer from lab to pilot/commercial scale for robust manufacturing processes.
  • Track record of mentorship, strategic leadership, and driving innovation through cutting-edge analytical tools and statistical/predictive approaches.

Overview

5
5
years of professional experience
1
1
Certification

Work History

Associate Director, QC-Analytics

Franklin Biolabs
10.2024 - Current
  • Led the planning and execution of analytical experiments to optimize biologics development workflows and enhance lab productivity.
  • Provided technical support to improve laboratory efficiency and refine experimental setups for complex large molecule products.
  • Oversaw analytical testing under GxP conditions, ensuring stringent quality compliance and adherence to established protocols.
  • Directed the implementation of new analytical technologies and method development initiatives to advance lab capabilities.
  • Mentored and trained junior scientists on analytical methods and process principles, contributing to team capability build.

Associate Director, Phys./Chem. Characterization

Gene Therapy Program | University of Pennsylvania
08.2021 - 09.2024
  • Spearheaded a team of scientists developing cutting-edge analytical characterization techniques for Biologics, large molecule products, and viral vector components.
  • Facilitated 2 successful IND filings by providing robust analytical data packages and CMC support for clinical supply production.
  • Optimized LC-MS-based analytical methods for viral vector components (e.g., capsid serotyping workflow), resulting in a remarkable 30% increase in testing efficiency.
  • Orchestrated the adoption of innovative technology and streamlined workflows for material characterization and stability testing, leading to a 10% reduction in testing costs and a 13% improvement in efficiency.
  • Successfully managed a portfolio of multiple projects concurrently, ensuring on-time completion and adherence to stringent quality standards.
  • Guided and mentored junior scientists, contributing to their career success in analytical development.

Senior Research Scientist

Rockland Immunochemicals, Inc.
02.2021 - 08.2021
  • Provided direct support to the Bioconjugation Department by developing antibody, resin, and carrier protein conjugates.
  • Developed bioanalytic methods to assess conjugation efficiency and quality of bioconjugates.
  • Revised and optimized technical protocols and procedures for bioconjugation processes, offering training and guidance to team members.
  • Engineered and validated an innovative workflow, culminating in a 20% surge in yield for secondary antibody bioconjugations.

Analytical Scientist

Wuxi Biologics
02.2020 - 02.2021
  • Acted as analytical Subject Matter Expert (SME), supporting process development studies for late-stage vaccine development.
  • Cultivated expertise in bioanalytical method development for drug substance characterization and impurity determination.
  • Successfully executed 3 analytical method tech transfers within 3 months, drafting 3 method SOPs and 2 instrument SOPs.
  • Analyzed and interpreted data, communicating results to cross-functional scientists to validate assays and analyze method performance trends.

Education

Ph.D. - Biochemistry

University of Hawaii At Manoa
Honolulu, HI
11-2019

Master of Science - Biotechnology

National Yang-Ming University
Taipei, Taiwan
06-2011

Bachelor of Science - Bioengineering

Tatung University
Taipei, Taiwan
06-2009

Skills

  • Bioconjugation Development & Optimization
  • Analytical Method Development & Validation
  • LC-MS, HPLC, UPLC, SEC-MALS
  • Biomacromolecule Characterization
  • Process Analytical Support & Optimization
  • GxP & Quality Compliance
  • Technical Transfer & Documentation
  • Project Leadership & Client Management

Certification

  • LabVantage Familiarization Training, LabVantage Solutions, Inc - Issued Dec 2024
  • Data Analysis with Python, IBM - Issued Jun 2024

Timeline

Associate Director, QC-Analytics

Franklin Biolabs
10.2024 - Current

Associate Director, Phys./Chem. Characterization

Gene Therapy Program | University of Pennsylvania
08.2021 - 09.2024

Senior Research Scientist

Rockland Immunochemicals, Inc.
02.2021 - 08.2021

Analytical Scientist

Wuxi Biologics
02.2020 - 02.2021

Ph.D. - Biochemistry

University of Hawaii At Manoa

Master of Science - Biotechnology

National Yang-Ming University

Bachelor of Science - Bioengineering

Tatung University

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