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BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Job Description:
Lead and participate in the validation activities include URS/FAT/SAT/IQ/OQ/PQ of DS downstream Equipment；
组织并参与下游生产设备的URS、FAT、SAT、IQ、OQ、PQ；
Lead and participate in GMP documents preparing, revising, and management of DS downstream department ；
组织并参与准备下游GMP文件起草，修订，管理等；
Lead and participate in validation jobs of DS downstream department；
组织并参与准备下游生产的验证工作；
Make production Plan according to the supply chainplan, include documents preparation, material preparation, buffer preparation, process operation, people management, and so on；
按照生产计划组织开展工艺生产活动，包括文件准备、物料准备、溶液准备、工艺操作,团队管理等相关活动；
To be responsible for the training, instruction and management of DS downstream, coordinate effective communication and cooperation among units relating to production and to ensure the successful completion of production;
负责下游的培训、指挥与管理，协调各个生产相关部门的沟通与合作，保证生产的顺利完成；
Any other assignment as is determined by supervisor.
完成上级安排的其他工作。
组织并参与下游生产设备的URS、FAT、SAT、IQ、OQ、PQ；
Lead and participate in GMP documents preparing, revising, and management of DS downstream department ；
组织并参与准备下游GMP文件起草，修订，管理等；
Lead and participate in validation jobs of DS downstream department；
组织并参与准备下游生产的验证工作；
Make production Plan according to the supply chainplan, include documents preparation, material preparation, buffer preparation, process operation, people management, and so on；
按照生产计划组织开展工艺生产活动，包括文件准备、物料准备、溶液准备、工艺操作,团队管理等相关活动；
To be responsible for the training, instruction and management of DS downstream, coordinate effective communication and cooperation among units relating to production and to ensure the successful completion of production;
负责下游的培训、指挥与管理，协调各个生产相关部门的沟通与合作，保证生产的顺利完成；
Any other assignment as is determined by supervisor.
完成上级安排的其他工作。
Qualification Required:
Education/ Professional Qualification
学历/专业资格
Bachelor or above degree in Pharmaceutical, Chemical, biological or related field.
药学、化学、生物学或相关学科学士或以上学位。
Technical/Skills Required
技术/技能训练
Familiar with the regulatory requirement of NMPA cGMP、EU cGMP、PIC/S and FDA cGMP；
熟悉NMPA cGMP、EU cGMP、PIC/S 及FDA cGMP的要求；
Familiar with MAB Downstream Purification techniques and scale up of process, including Chromatography, Viral inactivation, Viral filtration, UF/DF etc；
熟悉抗体下游纯化技术和工艺放大，包括层析，病毒灭活，除病毒过滤，超滤/透析等；
Strongly address, investigate and solve ability.
具有较强的处理、分析和解决问题的能力。
Working Experience
工作经验
At least 5 years BIO manufacturing experiences and at least 2 years supervisory/managerial roles.
医药行业5年以上生物制药生产经验，2年以上生产主管经验。
Language, Computer Literacy, Office Software, etc.
语言能力，电脑知识，办公软件等
Good English and computer skill.
英语水平良好，会熟练使用电脑。
Others
其他
Proactive and dedicated with a strong sense of responsibility and integrity;
积极敬业、主动进取、责任心强、正直向上；
Competent in organization and coordination, team leadership, analytical skills and problem solving;
有较强的组织协调能力、良好的团队领导力、较强的分析和解决问题的能力；
Good communication skills.
具有良好的沟通表达能力.
学历/专业资格
Bachelor or above degree in Pharmaceutical, Chemical, biological or related field.
药学、化学、生物学或相关学科学士或以上学位。
Technical/Skills Required
技术/技能训练
Familiar with the regulatory requirement of NMPA cGMP、EU cGMP、PIC/S and FDA cGMP；
熟悉NMPA cGMP、EU cGMP、PIC/S 及FDA cGMP的要求；
Familiar with MAB Downstream Purification techniques and scale up of process, including Chromatography, Viral inactivation, Viral filtration, UF/DF etc；
熟悉抗体下游纯化技术和工艺放大，包括层析，病毒灭活，除病毒过滤，超滤/透析等；
Strongly address, investigate and solve ability.
具有较强的处理、分析和解决问题的能力。
Working Experience
工作经验
At least 5 years BIO manufacturing experiences and at least 2 years supervisory/managerial roles.
医药行业5年以上生物制药生产经验，2年以上生产主管经验。
Language, Computer Literacy, Office Software, etc.
语言能力，电脑知识，办公软件等
Good English and computer skill.
英语水平良好，会熟练使用电脑。
Others
其他
Proactive and dedicated with a strong sense of responsibility and integrity;
积极敬业、主动进取、责任心强、正直向上；
Competent in organization and coordination, team leadership, analytical skills and problem solving;
有较强的组织协调能力、良好的团队领导力、较强的分析和解决问题的能力；
Good communication skills.
具有良好的沟通表达能力.
百济神州全球胜任力
当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。
- 团队协作
- 提供并征求坦诚及可行的反馈
- 自我认知
- 兼容并蓄
- 积极主动
- 开拓精神
- 持续学习
- 拥抱变化
- 结果导向
- 分析性思维/数据分析
- 卓越财务
- 清晰沟通
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
求职者隐私申明：
百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息
）。
由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（
https://www.beigene.com/privacy-policy
）。
如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。
BeiGene is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity.
Due to the reasonable business need for human resource management as a result of BeiGene’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeiGene Job Applicant Privacy Policy (
https://www.beigene.com/privacy-policy
).
If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeiGene Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.
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