上游工艺开发总监/副总监USPDirector/AssociateDirector

面议

苏州市

刷新时间：2022-10-26

职位描述

  职位目标 Purpose or Objective of Position: 

领导生物药CMC-USP团队，负责生物药项目pre-IND阶段的研发以支持IND申报及临床样品制备及GMP生产。

 Lead the biological drug CMC-USP team, responsible for the research and development of pre-IND phase of biological drug project to support IND application, clinical sample preparation and GMP production. 主要职责 Key Responsibilities： 

⚫ 负责带领团队进行细胞培养工艺开发，承担高表达细胞株筛选以及工艺优化及生产等工作； 

In charge of leading the team to develop the cell culture process, and responsible for the screening of high-expression cell lines and the process optimization. 

⚫ 负责小试细胞培养工艺向中试生产的放大和技术转移，协助生产进行工艺放大；

 Be responsible for the amplification and technology transfer from the small cell culture process to the pilot production, and assist in the process amplification 

⚫ 负责团队管理，依据法规和技术要求制定实验方案和操作规程，员工培训等。 

Be responsible for team management, make experiment plan and operation procedure, staff training and so on according to the regulations and technical requirements 

关键绩效指标KPI’s ⚫ 抗体新药工艺开发与GMP生产。

 Antibody new drug process development and GMP production 

⚫ 技术转移及工艺优化

 Tech transfer and process optimization.

职位要求Job Requirements: Education:  

硕士及以上学历，且从事生物药工艺开发工作不少于6年，生物相关专业。 

Master degree or above, and engaged in the development of biological drug process for at least 6 years, majored in biology. Experience: 

⚫ 具备部门内部及部门间的管理协调能力，以及多项目同步推进的项目管理经验； 

Have the ability to manage and coordinate within and between departments and have the experience of project management for the simultaneous promotion of multiple projects. 

⚫ 熟悉生物类新药开发流程，参与过2-3项生物药申报资料撰写，其中至少主导一项；

 Familiar with the development process of new biological drugs, participated in the preparation of 2-3 biological drug application materials, led at least one of them. 

⚫ 熟悉抗体新药工艺开发与GMP生产要求，了解抗体新药开发过程质量研究要求、质量标准建立等工作要求与开发流程；

Familiar with the development of new antibody drug process and the production requirements of GMP, understand the quality research requirements of the development of new antibody drug, the establishment of quality standards and other work requirements and development process. 

⚫ 了解非临床研究过程，能够运用项目管理方法以及工作软件合理安排计划、跟踪项目进展以及计划调整； 

Understand the non-clinical research process, be able to use project management methods and working software to arrange plans, track project progress and adjust plans. &nbs*****>

其他要求

招聘人数：1人
语言要求：英语
职能类别：工艺工程师

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。