API Supply Management Associate Director / Sr. Manager

Job responsibility:

  1. • Manage API production resources, timeline, and delivery for Hua drug development programs.
  2. • Identify, evaluate, and qualify potential suppliers for API, intermediate, and starting material production.
  3. • Continuously monitor and evaluate the performance of API, intermediate, and starting material suppliers; periodically provide SWOP analysis of suppliers.
  4. • Implement on-site monitoring for API/intermediate production.
  5. • Work with external partners (CMOs) to implement production of APIs or intermediates, and ensure on time delivery of high quality products to support Hua drug development programs.
  6. • Work with external partners to implement tech-transfer.
  7. • Serve as the expert in the area of supply chain management, contribute to internal cross function project team and buildup of CMC function.
  8. • Other assigned duties to meet company objectives.
  9. Qualifications:
  10. • PhD with 3+ year experience or MS with 6+ year experience in the field of API manufacturing and process R&D.
  11. • Extensive experience in plant production, strong skills of problem solving.
  12. • Extensive experience and good knowledge on GMP, knowledge/experience in analytical chemistry will be a plus.
  13. • Strong communication and influencing skills; Good technical writing skills in both Chinese and English.
  14. • Extensive knowledge of general drug R&D process and experience in working with/at CMO.
  15. • Good team player but can work independently.
  16. • Be flexible to travel.