Associate Director/Director Analytical Science

Major Responsibilities

  1. • Responsible for the analytical related works of analytical research and analytical development.
  2. • Manage the analytical works through external collaboration.
  3. • Review and approve the analytical research protocol, progression report and summary report etc. and on-site monitor the ongoing analytical activities.
  4. • Working together with external partner and internal CMC team members, propose and approve the Analytical & Control method, specification etc.
  5. • Prepare and review the filing documentation of quality research.
  6. • Serve as an expert / specialist in the field of analytical areas, constructive recommendation for project moving forward.
  7. • Represent Analytical discipline at internal and external meeting and provide the scientific points and knowledge-sharing.
  8. • Be a member of Chemistry, Manufacture & Control (CMC) Committee, contribute to the CMC development plan discussion, and functional development etc.
  9. • Prepare internal analytical related the standard operating procedure (SOP), and join in reviewing, evaluating the external partner's SOPs.
  10. • Other related duties as assigned to meet company objectives.

  11. Requirement
  12. • Ph.D. with 2 ~ 4 years or M.S. with above 8 years relevant work experience in analytical chemistry, pharmaceutical analysis, and separation science etc.
  13. • Comprehensive knowledge in qualitative analysis and quantitative analysis.
  14. • Good knowledge of separation science, chromatographic and spectrometric analysis etc.
  15. • Demonstrated teamwork skills and ability to communicate, good work attitude etc.
  16. • Demonstrated the capabilities of leadership and management.
  17. • The working experience in GMP compliance is a plus.