BioNTech SE

原液总监

BioNTech SE  •  Nantong, CN (Onsite)  •  4 months ago
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Job Description

岗位职责:

  • 全面负责从细胞复苏、扩增、生产培养到收获、纯化、超滤透析等原液生产全过程的管理;
  • 制定并执行详细的生产计划,合理调配资源,确保生产任务按时完成;
  • 监督生产过程中的关键工艺参数(CPP)和关键质量属性(CQA),确保产品符合预定的质量标准;
  • 负责生产批记录、日志和其他相关文件的审核与批准;
  • 确保所有生产活动严格遵守中国NMPA、美国FDA、欧盟EMA等国际cGMP法规及公司质量体系要求;
  • 主导生产区域的内外部审计(包括官方审计、客户审计和内部审计),并负责审计发现项的整改闭环;
  • 负责生产偏差(Deviation)、变更控制(Change Control)、纠正与预防措施(CAPA)的发起、调查和处理;
  • 与质量保证(QA)、质量控制(QC)、MSAT等部门紧密合作,确保生产全过程受控;
  • 负责原液生产团队的招聘、培训、绩效考核和日常管理;
  • 制定并实施团队培训计划,提升团队的技术能力、GMP意识和操作技能;
  • 营造积极、安全、高效和持续改进的团队文化;
  • 参与从工艺开发(PD)部门到GMP车间的技术转移工作,确保工艺的稳健放大和成功落地;
  • 主导生产过程中的工艺监控和数据分析,识别改进机会,发起并领导工艺优化项目,提高产率、降低成本和缩短周期;
  • 负责生产相关SOP的编写、修订和培训;
  • 与工程和运维部门协作,确保生产设备(如生物反应器、层析系统、超滤系统等)处于良好的验证和运行状态;
  • 负责生产区域的日常管理,包括环境监测、清洁消毒和物料流转。

任职要求:

  • 至少10年以上在生物制药行业(抗体或重组蛋白领域优先)的GMP生产经验;
  • 至少5年以上的原液生产团队管理经验,曾担任主管、经理或同等职位;
  • 精通抗体药物原液生产工艺,深刻理解细胞培养(如CHO细胞)和蛋白纯化(层析、过滤)的原理和操作;
  • 精通cGMP法规(中美欧),并具备丰富的审计迎检和现场管理经验;
  • 出色的偏差调查、根源分析和CAPA管理能力;
  • 优秀的团队领导、沟通协调和项目管理能力;
  • 具备良好的中英文读写能力,能阅读和撰写专业技术文件;
  • 具有临床后期或商业化阶段抗体药物生产技术转移和规模放大成功经验;
  • 熟悉一次性生产技术和主流设备(如Sartorius, Cytiva, Pall等)的应用;
  • 具备新建生产线调试、验证或 startup 经验者优先;
  • 有国际生物制药公司工作经验者优先。
BioNTech SE

About BioNTech SE

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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🔗 Imprint: https://www.biontech.com/int/en/home/imprint.html

Industry
Biotech & Life Sciences
Company Size
5,001-10,000 employees
Headquarters
Mainz, DE
Year Founded
2008
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