Chongchuan District, Jiangsu, China · On-site
岗位职责： 负责配液支持区域人员的招聘，培训，绩效考核； 按照GMP的规范以及生产计划完成制剂生产，包括原液化冻、原辅料及包材的领用，容器具清洗、包扎、灭菌，原辅料的称量，配制等生产活动； 负责制剂配液区域清洁卫生及环境的维持； 负责制剂配液支持区域记录的填写，包括但不限于：房间清洁记录，设备使用记录，批生产记录等； 协助生产过程中偏差调查、变更等文件及报告的起草； 负责生产过程及日常行为严格遵守EHS、IP保护等合规准则； 协助验证部…
Skills: GMP Compliance, Biopharmaceutical Production, Formulation Process, Sterilization Process, Personnel Management
Chongchuan District, Jiangsu, China · On-site
岗位职责： 全面负责QA体系组的管理工作； 负责主导工厂质量指标的制定、监督和回顾； 负责主导工厂生产许可证的申请与维护； 负责工厂体系文件的维护与更新，确保体系的正常运营； 负责监管偏差、变更、CAPA和质量风险管理等合规审核； 负责工厂自检的管理，制定年度自检计划，并按计划完成自检与CAPA跟踪； 负责组织和协调外部客户与药监机构的检查工作，起草整改回复报告； 负责组织偏差审核会议、变更审核会议，并与客户积极沟通审核结果； 负责主导…
Skills: QA System Management, Quality Risk Management, CAPA, Compliance Auditing, Regulatory Affairs
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Manage the recruitment, training, and performance of personnel in the formulation support area while ensuring production follows GMP standards. Oversee daily operations including raw material weighing, formulation, sterilization, and the maintenance of cleanroom environments and documentation.
Requires a bachelor's degree or higher in pharmaceutical formulation, pharmaceutics, or a related field. Candidates must have over 6 years of GMP experience in biopharmaceutical production and possess strong English communication skills.
Our vision is to harness the power of the immune system to develop novel therapies against cancer & infectious diseases.
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
Offices: An der Goldgrube 12, Mainz, Rhineland-Palatinate 55131, DE · Vollmersbachstraße 66, Idar-Oberstein, Rhineland-Palatinate 55743, DE · Vollmerstr. 5, Berlin, Berlin 12489, DE · Am Klopferspitz 19a, Planegg, Bavaria 82152, DE · Forstenrieder Str. 8-14, Neuried, Bavaria 82061, DE
Our vision is to harness the power of the immune system to develop novel therapies against cancer & infectious diseases.
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
Offices: An der Goldgrube 12, Mainz, Rhineland-Palatinate 55131, DE · Vollmersbachstraße 66, Idar-Oberstein, Rhineland-Palatinate 55743, DE · Vollmerstr. 5, Berlin, Berlin 12489, DE · Am Klopferspitz 19a, Planegg, Bavaria 82152, DE · Forstenrieder Str. 8-14, Neuried, Bavaria 82061, DE
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