1. Develop analytical methods, perform analytical tests, and assist the RD team in screening formulations for the NDA and ANDA drug development.
制定分析方法，進行分析測試，並協助RD團隊篩選用於NDA和ANDA藥物開發的製劑。
2. Follow laboratory SOPs and ensure GMP compliance.
遵循實驗室SOPs並確保符合GMP規範
3. Prepare technical documents and review data for the R&D projects and drug submission.
為研發專案和藥物開發準備技術文件並審查數據
4. Responsible for performing the R&D tasks and projects, such as analytical method development, method validation, formulation screening, raw material tests, finished product release, stability study, and dissolution testing.負責執行研發任務及專案，例如分析方法開發、方法確效、配方篩選，原料測試、成品放行、安定性研究和溶出度測試。
5. Use and maintain analytical instruments, GC, HPLC, UPLC,LC-MS Dissolution Tester, Titrator, Particle size analyzer, etc. Research, diagnose, troubleshoot, and identify solutions to resolve analytical instrument issues.
使用和維護分析儀器，GC，HPLC，UPLC，LC-MS溶出度測試儀，滴定儀，粒徑分析儀等。研究，診斷，故障排除和識別解決方案以解決分析儀器問題。
6. Train, lead, and supervise junior analysts in day-to-day laboratory operations. Support relevant departments and vendors to complete projects on time, ensure the work and analysis comply with GMP and SOPs.
訓練、領導並監督日常實驗室操作中的初級分析師。協助相關部門和供應商按時完成專案，確保工作和分析符合GMP和SOPs。
7. Review documents, prepare the analytical study report and CMC documents
審查文件，準備分析研究報和CMC文件
8. Responsible for establishing, maintaining, and updating the specifications and test methods for in-process and finished products in the pre-approval phase.
負責核准前半成品和成品試驗相關之檢驗方法與規格之制定、維護與更新。
9. Support assigned responsibilities to maintain GMP compliance of the chemical laboratory, as applicable.
依據分配責任，維持化學實驗室運作皆符合GMP規範
10. Promptly complete work and tasks assigned by superior
及時完成上級下達的工作和任務。
11. Support for analytical method transfer to analytical control, QP sites, and other receiving laboratories.
協助將分析方法轉移到分析控制，QP所在地和其他接收實驗室。
12. Cooperating with PD & RA, complete and all lab tests.
配合PD及RA完成各項化驗項目。
13. Ensure analysis can be conducted with efficiency and completed on time
確保分析工作得以高效率及迅速之進行。
14. Managing and maintaining instrument calibrations, laboratory instrument logbooks, and SOPs.
各儀器設備SOP之制訂、管理、定期維護、校正如期完成。
15. Ensure lab work is conducted according to SOP and complies with EU, US, JP, and global cGMP regulations.
確保其實驗操作皆依照SOP進行，並符合歐美日地區及全球cGMP之規定。
