Director of DSP

¥81k - ¥125k pm
Permanent
Shanghai
17 Jun 2022
BBBH819435

Manage the downstream team and be responsible for the progress report and internal and external communication and coordination of the purification part

Responsibility:

1.Manage the downstream team and be responsible for the progress report and internal and external communication and coordination of the purification part of the project at the internal / external project

meeting;

管理下游团队,在内/外部项目会上负责项目纯化部分的进展汇报及内外沟通协调;

2.Development and optimization of purification process of leading protein / polypeptide drugs;

3.Carry out defect risk analysis on the amplification process to ensure the feasibility of process operation in large-scale production;

主导蛋白/多肽类药物的纯化小时工艺开发和优化;

4.Review process development plan, periodic report,sample plan, experimental records and other technology transfer documents;

对放大工艺进行缺陷风险分析,保证工艺操作在大规模生产中的可行性;

5.Keep good communication and cooperation with upstream and downstream, preparation and analysis departments to ensure the

smooth progress of sample source, analysis and testing;

审核工艺开发方案及阶段性报告,样品计划,实验记录等技术转移文件;

6.Lead to write and review the application materials related to purification

与上下游、制剂及分析部门保持良好沟通合作,保证样品来源与分析检测等工作顺利进行;

7.Lead to write and review the application materials related to purification

主导撰写纯化相关申报资料并审核;

Require:

1.more than five years of relevant experience in downstream purification process development in biopharmaceutical industry, including more than 2 years of team management experience;

生物制药相关专业博士及以上学历,六年以上生物制药行业下游纯化工艺开发相关经验,其中2年以上团队管理经验

2. Be familiar with the purification process development process of antibody and non antibody protein drugs, and be able to design the corresponding process route according to the characteristics of products;

熟悉抗体类、非抗体类蛋白质药物纯化工艺开发流程,能根据产品的特点设计相应的工艺路线;

3. Be familiar with the workflow of new drug research and development, quality control, registration and application and the regulatory requirements of biological product approval;

熟悉新药研发、质量控制及注册申报等工作流程及生物制品审批的法规要求;

4. Experience in more than 2 protein drug process development projects, and successful clinical application experience is preferred;

有2个以上蛋白质药物的工艺开发项目经验,有临床申报成功经验优先考虑;

5.English can be used as a working language.

英语能作为工作语言。

Team Leader | M3S Recruitment
86 21 8033 3012 | lqin@morganmckinley.com