AD生化方法开发经理

一岗位职责：

1. 根据工艺开发进度，组织实施中间样品、non-GMP相关方法开发和检验工作，如结合活性、生物活性HCP、HCD、protein A残留等。
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. 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. 负责生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 biochemical 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生化团队的日常管理、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 biochemical team.
6. 完成领导分配的其他工作和职责。
Any other job and responsibilities assigned by manager.

二.任职资格

1、至少具有药学或生物相关专业硕士学历（或中级专业技术职称或执业药师资格）。
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年从事抗体类生物制品生化相关分析的实践经验。
At least 3 years hand on experience in biochemical analysis of antibody biologics.
3、能够阅读相关的英文资料。
Be able to read related English materials.