Li-Wei Chang

About Li-Wei Chang

Energetic Postdoctoral Researcher with expertise in molecular design and formulation development of polymer-based complex materials (biodegradable microparticles, and complex coacervation) for applications ranging from industrial coating and adhesives to protein encapsulation and drug delivery. Two plus years of industry experience working in scale-up, troubleshooting, new process and formulation development at Taiwan Semiconductor Manufacturing Company (TSMC) and BASF. Currently working on developing biodegradable microcapsules with novel surface morphology and strong adhesion for stimuli-responsive on-demand drug delivery system.

Experience

1. Senior Scientist

   Regeneron

   Mar 2023 — Present · Tarrytown, NY, US

   Full Lifecycle Drug Product Development: Over eight years of experience in the formulation of mixed modalities (mAbs, bispecifics, polypeptides, and enzymes) from preclinical developability and late-stage formulation development to commercial BLA filing.• Early-Stage De-risking: Proven expertise in lead candidate assessment, optimizing analytical methods and stability profiles to identify and de-risk molecules for preclinical toxicology studies.• Late-Stage Program Management: Directed two complex biological drug development projects to optimize commercial formulations, successfully mitigating degradation risks and overseeing technical transfer to production facilities.• Regulatory Filing Leadership: Track record in IND and BLA-enabling GLP studies, including leading the authoring and technical review of BLA sections 3.2.P.2, P.2.4, and P.2.6 with a proven ability to align CMC regulatory, QA, and manufacturing workstreams to meet accelerated timelines.• Manufacturing Scale-Up Excellence: Extensive experience in tech transfer and manufacturing robustness, including comparability studies (2kL to 10kL) and the implementation of JMP DOE.• Innovative Predictive Modeling: Expert in applying \"predictive approaches,\" such as the Subcutaneous Injection Site Simulator (SCISSOR) and empirical viscosity modeling, to inform molecule selection and reduce formulation screening timelines.• Scientific and Matrix Leadership: Recognized technical expert with a distinguished publication record (e.g, Nature Communications) and a proven ability to lead high-visibility projects, including the strategic implementation of Optical-Photothermal Infrared (O-PTIR) technology to enhance departmental characterization capabilities.

Education

• University of Massachusetts Amherst

  Doctor of Philosophy (PhD), Chemical Engineering

  2014 — 2020

• National Central University

  Master's degree (MS), Chemical and Materials Engineering