Experience

Vysioneer

• United States
• Software Development
• 1 - 100 Employee

• Regulatory Specialist

  • Feb 2021 - Present



SynCore Biotechnology Co., Ltd.

• Biotechnology Research
• 1 - 100 Employee

• Assistant Project Manager

  • Aug 2020 - Jan 2021

  - Manage overseas contract manufacturer and laboratories- Plan and schedule drug product production and analysis- Manage analytical method developments/validations projects and process validation activities- Resolve project issues through collaboration with subject experts and external consultants- Ensure effective communication, reporting and escalation to upper management- Maintain cGMP batch records, CMC regulatory and quality documents- Write and review documents (e.g. IMPD, eCTD) for NDA / regulatory submissions- Organize and moderate project team meetings- Plan and monitor project to achieve timeline, budget and scope- Perform project costing and budgeting

• Project Specialist

  • Nov 2018 - Jul 2020

  Assisted in clinical site management, clinical supplies management and chemistry, manufacturing and controls (CMC) projects.



National Taiwan University

• Taiwan
• Higher Education
• 700 & Above Employee

• Teaching Assistant

  • Sep 2016 - Jun 2017

  Teaching assistant of biochemistry laboratory course Teaching assistant of biochemistry laboratory course