General Responsibilities: 1.根据工艺开发进度,组织实施中间样品相关方法开发和检验工作,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.负责起草检测方法和仪器操作的SOPs,包括分析方法、仪器操作,并进行方法转移至QC部门。 Responsible for drafting SOPs related to method and instrument operation and transfer the methods to the QC department.
3.负责理化相关分析方法开发报告的起草和审核工作,以及质量板块CTD注册资料的撰写。 Responsible for drafting and reviewing method development reports related to physicochemical assay and the write the CTD registration materials for the quality section.
4.负责管理、维护保养检验设备,确保检验设备可正常运行且在有效期内。 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.负责AD团队的日常管理、年度培训、绩效评价、成本优化等。 Responsible for daily management, annual training, performance evaluation, cost optimization, etc. of the AD team.
6.完成AD经理分配的其他工作和职责。 Any other job and responsibilities assigned by AD manager. 任职资格: 1、生物药经验,5年以上工作经验,有团队管理经验优先 2、理化方法开发经验,有生物药抗体药优先