Cheng-Kang Pai

Experience

• 

  Taiwan Liposome Company

  Jul 2013 - Apr 2016

  Associate Researcher

  Liposomal drug process development, Technology transfer, CMO coordination, Supply chain management and qualification

• 

  Genovior Biotech Corporation

  May 2016 - Nov 2016

  Project Manager

  Biopharmaceutical development from RD laboratory to manufacturing site, Manufacture facility design for GMP complied, Account management, Project and budget management

• 

  Trust Bio-sonics

  Dec 2016 - Nov 2018

  Manager

  Complete the IND approval from FDA for NCE drug.Drug development, Process and analytic method validation, Technology transfer, CMO management and audit, Supply chain management and audit, Quality system establishment for GMP complied, CMC document preparation for regulation submission

• 

  TTY

  Dec 2018 - Jun 2023

  Responsible for microbial quality control of drug product and raw material. Microbial control for environment, utilities, and facilities of pharmaceutical factory. Develop and validate analytical methods of microbial and endotoxin tests. Review analytical protocols and reports. Manage the Microbial Section and personnel assessment.

  • Microbial Section Head / Associate Manager

    Apr 2022 - Jun 2023

  • Microbial Section Head / Supervisor

    Dec 2018 - Mar 2022
• 

  UBI Pharma Inc

  May 2023 - Dec 2023

  Quality Compliance Manager

  Responsible for GMP internal and external inspection, deviation and OOS investigation, change control management, document control and system management, supplier inspection and management, GMP training, and Quality Agreement revision.

• 

  Pharmosa Biopharm Inc

  Dec 2023 - now

  Quality Assurance Manager

  Responsible for establishing the quality system for GMP compliance, including the procedures of document control, GMP training, deviation and OOS investigation, change control management, vendor management, validation and qualification, and so on.