岗位职责：
1.参加GMP培训并遵循GMP规则在车间内完成生产任务；
2.负责和保证上游生产各工序按照公司要求开展生产工作；
3.负责组织生产上游部门GMP相关文件的撰写、升版和审核工作；
4.负责改进并优化生产流程及工作方法，定期进行总结和汇报；
5.负责板块内生产人员的技术、设备、规范、工艺等相关文件的培训与考核；
6.负责组织和协调变更的发起和组织风险评估以及方案制定等工作；
7.负责上游生产中出现的偏差、偏离、异常事件的调查和组织工作（偏差、变更、CAPA等）；
8.参与NMPA、FDA等审计部门或合作单位审计，并根据审计整改项执行整改及反馈；
9.与研发部门、MSAT部门、供应链部门、工程部门、QA部门、QC部门等相互合作，推进生产的顺利进行。
任职要求：
1.本科及以上学历；微生物、生物化学、生物制药和发酵工程等专业优先；
2.有8-10年及以上相关生物制药行业GMP工作经验，有多批次临床或商业化生产经验；
3.掌握上游生产设备的操作原理、维护、管理；
4.熟悉生物药GMP厂房的运行和管理；
5.具备细胞培养板块人员招聘、培训、带队伍、现场管理等职能；
6.具备控制所管理板块预算和成本，实现投入和产出合理化；
7.具有良好的沟通表达能力；
8.熟悉生物制药领域GMP的相关法规要求；
9.熟悉偏差发起、调查、关闭和CAPA执行的整个质量管控过程；
10.具备较好的英文阅读和书写能力，能够审阅GMP相关文件；
11.具有吃苦耐劳的品质和良好的身体素质，与积极向上持续学习的能力；
12.具备国内/国外相关审计经验；
13.英文CET-6以上。
Biopharmaceutical New Technologies (BioNTech) is a global biotechnology company aspiring to translate science into survival by developing new immunotherapies utilizing the full potential of the immune system to fight cancer and infectious diseases.
BioNTech is headquartered in Mainz, Germany, and operates globally with almost 7.000 pioneers. Our work is powered by one mission: Improving the health of people worldwide. We believe that scientific rigor and passion are the driving forces that are essential for innovative progress.
BioNTech was founded in 2008 by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. At BioNTech, we have been conducting fundamental research of mRNA technologies in the field of individualized cancer medicine for more than a decade. Some of our colleagues, including our co-founders, have been researching and developing mRNA-based vaccines for more than 25 years.
Ready to join us on this journey? Explore the opportunities and become part of a team that aspires to turn bold ideas into real-world solutions: https://www.biontech.com/int/en/home/careers.html
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