崗位職責(zé):
主要職責(zé)Major Responsibilities:
General Responsibilities:
1.根據(jù)工藝開發(fā)進(jìn)度,組織實施中間樣品相關(guān)方法開發(fā)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(fù)責(zé)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(jìn)行方法轉(zhuǎn)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(fù)責(zé)理化相關(guān)分析方法開發(fā)報告的起草和審核工作,以及質(zhì)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(fù)責(zé)管理、維護(hù)保養(yǎng)檢驗設(shè)備,確保檢驗設(shè)備可正常運(yùn)行且在有效期內(nèi)。
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(fù)責(zé)AD團(tuán)隊的日常管理、年度培訓(xùn)、績效評價、成本優(yōu)化等。
Responsible for daily management, annual training, performance evaluation, cost optimization, etc. of the AD team.
6.完成AD經(jīng)理分配的其他工作和職責(zé)。
Any other job and responsibilities assigned by AD manager.
任職要求:
1、5年以上工作經(jīng)驗,有團(tuán)隊管理經(jīng)驗優(yōu)先
2、理化方法開發(fā)經(jīng)驗,有生物藥抗體藥優(yōu)先