1. A M.S. or Ph.D. degree in Chemistry or Pharmacy with no less than two years of industry
R&D experiences.
2. Strong background in analytical/medicinal/or organic chemistry.
3. Well-experienced in analytical method development and validation.
4. Hands-on experience in the development and characterization of intermediate of active
pharmaceutical ingredient , formulation development and/or PK study analysis.
5. Excellent communication skills and good team spirit.
6.Looking for who is willing to take the challenge to be a pioneer combination chemist for
novel drug discovery of CNS disorder.
此職務是連結研發與 GMP 生產的重要橋樑。您將不僅負責製程優化與放大,還需執行毒理批次 (Tox material) 生產,並承擔技術轉移 (Tech Transfer) 至 GMP 的任務。此角色同時涵蓋 MSAT (Manufacturing Science and Technology) 的核心功能,確保製程具備穩健性、可重現性與 GMP 導入準備。
1) Process Operations and Scale-Up
- Manage and execute process operations ranging from 5 to 200 liters.
- Ensure consistency, scalability, and reproducibility of upstream processes.
2) Tox Material Production
- Lead the production of non-GMP toxicology batches to support preclinical studies.
- Ensure materials meet quality standards and development timelines.
3) Process Optimization and DOE
- Design and conduct experiments (DOE) to optimize upstream workflows.
- Continuously improve existing processes for better yield, efficiency, and robustness.
4) Tech Transfer to CDMO
- Prepare documentation and transfer processes to external CDMO partners.
- Provide MSAT support to ensure smooth transition into GMP environments.
5) Cross-Functional Collaboration
- Work closely with downstream, analytical, and quality teams to support integrated project needs.
- Effectively communicate results and process improvements through reports and presentations.
6) Laboratory and Project Support
- Assist in laboratory material management to ensure smooth operations.
- Support other functional teams as needed to meet project goals.