崗位職責:
主要職責Major Responsibilities:
General Responsibilities:
1.根據工藝開發進度,組織實施中間樣品相關方法開發和檢驗工作,如Titer、SEC、CE-SDS、DAR值、糖型等。
According to the progress of process development, organize and implement the relevant method development and inspection assay for in process samples, such as Titer、SEC、CE-SDS、DAR、Glycan,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.負責理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 physicochemical 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 team.
6.完成AD經理分配的其他工作和職責。
Any other job and responsibilities assigned by AD manager.
任職要求:
1、5年以上工作經驗,有團隊管理經驗優先
2、理化方法開發經驗,有生物藥抗體藥優先