BioNTech SE

制剂生产总监

BioNTech SE  •  Nantong, CN (Onsite)  •  4 months ago
Apply
AI can make mistakes so check important info. Chat history is never stored.

Job Description


岗位职责:

  • 参与协助制定公司发展战略和发展规划;
  • 组织和实施公司的战略规划和生产计划,确保制剂生产任务保质保量完成;
  • 根据公司计划制定本制剂生产计划和部门预算;
  • 负责制剂团队的搭建及梯度建设,绩效合同签订及考核;
  • 按照公司质量体系要求,强化并监督本部门员工的质量意识和风险意识,检查和回顾生产体系的运行情况,不断提升员工的意识;
  • 保障车间安全生产符合公司EHS要求,掌握生产车间的质量状态,沟通协调业务相关部门,解决生产过程中存在的问题;
  • 组织和协调生产车间新产品、新技术、新设备的引进;
  • 协助质量部门完成NMPA、FDA等外部审计部门或合作单位的审计,并根据审计整改项执行整改及反馈;
  • 负责制剂区域工作相关风险的识别与管理,按照GMP要求与公司内部流程,领导或参与偏差调查,偏差控制,CAPA的执行跟踪,自检等;
  • 负责制剂CDMO项目的管理,包括但不限于CDMO供应商的选择、考察、生产安排、生产过程管理、过程问题协调处理及最终产品的交付。

任职要求:

  • 本科本科及以上学历,药学、化学、化工、制药工程或相关专业。
  • 必需具备15年以上制药行业制剂生产经验,其中至少5年是在商业化生产环境中担任生产经理或以上职位。
  • 熟悉生物大分子药物生产相关理论知识,拥有丰富的、大规模的无菌制剂/液体制剂商业化生产管理经验,深刻理解规模化生产的挑战与解决方案。
  • 具备成功应对国内外药监部门(如NMPA, FDA)GMP审计的实战经验
  • 熟悉制剂相关的设备、生产工艺等理论知识;
  • 具备良好的沟通协调能力、领导力、团队协作能力及抗压能力;
  • 具备良好的职业素养;
  • 具备较强的监督、自我管理、执行力;
  • 英文可作为工作语言。
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

🔗 Privacy Statement: https://www.biontech.com/int/en/home/data-privacy-statement.html

🔗 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
Social Media