一崗位職責：

1. 根據工藝開發進度，組織實施中間樣品、non-GMP相關方法開發和檢驗工作，如結合活性、生物活性HCP、HCD、protein A殘留等。
According to the progress of process development, organize and implement the relevant method development and inspection assay for in process and non-GMP samples， such as Binding assay、Bioactivity、HCP、HCD、protein A residue，etc.
2. 負責起草檢測方法和儀器操作的SOPs，包括分析方法、儀器操作，并進行方法轉移至QC部門。
Responsible for drafting SOPs related to method and instrument operation and transfer the methods to the QC department.
3. 負責生化相關分析方法開發報告的起草和審核工作,以及質量板塊CTD注冊資料的撰寫。
Responsible for drafting and reviewing method development reports related to biochemical assay and the write the CTD registration materials for the quality section.
4. 負責管理、維護保養檢驗設備，確保檢驗設備可正常運行且在有效期內。
Be responsible for the management, maintenance and inspection of testing equipment to ensure that the testing equipment can operate normally and is within the validity period.
5. 負責AD生化團隊的日常管理、年度培訓、績效評價、成本優化等。
Responsible for daily management, annual training, performance evaluation, cost optimization, etc. of the AD biochemical team.
6. 完成領導分配的其他工作和職責。
Any other job and responsibilities assigned by manager.

二.任職資格

1、至少具有藥學或生物相關專業碩士學歷（或中級專業技術職稱或執業藥師資格）。
Must, at a minimum, have an educational qualification of an master course in pharmacy or biological related sciences (or with a technical title at middle grade or licensed pharmacist)
2、至少3年從事抗體類生物制品生化相關分析的實踐經驗。
At least 3 years hand on experience in biochemical analysis of antibody biologics.
3、能夠閱讀相關的英文資料。
Be able to read related English materials.