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[武汉]鼎康(武汉)生物医药有限公司

  1. 发布时间:2020-08-14
  2. 工作地点:武汉
  3. 职位类型:全职
  4. 来源:前程无忧(51JOB)
  5. 职位:工艺总监/PD Director
职能类别:其他

岗位描述:
Job Responsibilities
1. Lead Cell Culture group of Process Development, Supervise personnel, and organize/plan resources;
领导上游工艺开发团队,包括人员管理及资源配置与计划,在安全和合规的条件下,来实现部门的所有目;
2. Execute and evaluate laboratory-scale cell culture experiments in order to develop robust processes suitable for GMP clinical and commercial manufacturing;
执行和评估实验室规模的细胞培养实验,以开发适用于GMP临床和商业生产的稳定工艺;
3. Make use of sound statistical DOE-based strategy in order to understand deeply the impact of cell culture process parameters on target product quality;
利用合理的基于质量源于设计(DOE)策略,来深刻理解细胞培养工艺参数对产品目标质量属性的影响;
4. Write and review necessary process development related documents including process development reports, technical transfer reports, and characterization and validation protocols and electronic data histories;
撰写与审定必要的工艺开发相关文件,包括工艺开发报告,技术转移报告以及工艺表征和验证方案以及电子数据历史;
5. Write and revise protocols, procedures, reports, batch record and other process related documentation as necessary to support GMP manufacturing operations;
根据需要编写和修订实验方案,程序,报告,批记录和其他与工艺相关的文档,以支持GMP生产;
6. Develop employee’s knowledge, understanding, and skills to improve performance and expand abilities;
培养员工的知识,理解和技能,以提高绩效和扩展能力;
7. Ensure employees remain current with all department and site training requirement;
确保员工始终符合了解所有部门和现场培训要求;
8. Taking an active role in incident inquiry, investigation, and reporting;
积极参与事件调查和报告;
9. Communicate the group’s status, experiment data and feedback to management in a timely manner;
及时将小组的情况状态,实验数据和反馈传达给管理层;
10. Other work arranged by superior leaders.
上级领导安排的其他工作。

Job Requirements
11. Ph.D. or MS in Chemical/Biochemical Engineering, Biochemistry, Cell Biology, or related discipline with at least 5 years of experience focused on mammalian cell culture process development for the production of therapeutic proteins
化学/生化工程,生物化学,细胞生物学或相关学科的博士或硕士学位,具有至少五年工作经验,专注于开发用于生产治疗性蛋白质的哺乳动物细胞培养工艺;
12. Familiarity with laboratory procedures and operations including set up and operating shake flasks , lab scale bioreactors and pilot scale disposable bioreactors and associated analytical equipment used for mammalian cell culture processes.
熟悉实验室程序和操作,包括设置和操作摇瓶,实验室规模的生物反应器和中试规模的一次性生物反应器以及用于哺乳动物细胞培养工艺过程的相关分析设备;
13. Experience with medium selection, process optimization and process scale up.
具有培养基筛选,工艺优化,以及工艺放大的经验;
14. Experience with authoring IND, CTA, and BLA regulatory documents.
具有编写IND,CTA和BLA法规文件的经验;
15. Understanding of the application of GMP in the development and production process.
了解GMP在开发和生产过程中的应用;
16. Capable of writing details reports and summaries and exhibit detail oriented documentation skills;
擅长编写详细的报告和摘要,并具有详细的文档编制能力;
17. Communicate effectively and work professionally in a team environment;
善于在团队环境中进行有效沟通和专业工作;
18. Highly skilled in Word, Excel, and PowerPoint; experience with statistical DOE software;
精通各类办公软件,拥有统计DOE软件的经验;
19. Excellent oral and written communication skills in Chinese and English (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving complicated issues.
具有出色的中英文书写以及沟通能力,可通过与其他职能和管理人员进行沟通来解决各类问题。


公司简要介绍:

公司名称:鼎康(武汉)生物医药有限公司
公司类型:外资(非欧美)
公司介绍:


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