Job Requirements
工作要求
Education/ Professional Qualification
学历/专业资格
Bachelor or above degree in Pharmacy, Biology or Chemistry; alternatively. 
本科，制药工程专业。 
Technical/Skills Required
技术/技能需求
Familiar with downstream purification technologies, including deep filtration, chromatography, ultrafiltration, etc.  
熟悉下游纯化技术，包括深层过滤，层析，超滤等。
Working Experience
工作经验
Have 3 year or more experience in protein purification, deep filtration, ultrafiltration operation and so on.
3年或以上蛋白纯化，深层过滤，超滤等相关操作经验。
Experience in ADC DS production is preferred.
有ADC生产经验优先
Language, Computer Literacy, Office Software, etc.
语言能力，电脑知识，办公软件等
Familiar with Chinese and English expression（English level 6 is preferred）, strong language logic；
 较强的中英文表达能力，语言逻辑较强；
Familiar with the Office software like the Word, Excel, PowerPoint; 
熟练掌握Word, Excel，PPT等Office办公软件； 
Others
其他
Strong communication skills, a certain ability to work under pressure, Love to learn, good teamwork conscious. 
沟通能力较强，有一定的抗压能力，热爱学习，有良好的团队合作意识。

Roles/Responsibilities
职责
1. During the new project, responsible for the installation/commissioning and verification of new equipment, responsible for the daily management and maintenance of production equipment to ensure smooth production.
在新项目期间，负责新设备的安装/调试和验证，负责生产设备的日常管理和维护，确保生产顺利进行。
2. Assist workshop to complete the preparation and review of process related documents, such as: process procedures, MBR, SOP/WI and other technical documents.
协助车间完成工艺相关文件的编制和审核，如：工艺规程、MBR、SOP/WI等技术文件。
3. According to the production plan issued by the workshop, assist the supervisor to complete the production tasks such as conjugation, purification and preparation buffer on time and in quantity.
根据车间下达的生产计划，协助主管按时、按量完成偶联、纯化、缓冲液配制等生产任务。
4. Responsible for the use management of materials, including material application, return and nonconforming management; Make reasonable suggestions on material utilization optimization to reduce production cost.
负责物料的使用管理，包括物料申请、退货和不合格品管理；提出合理的物料优化利用建议，降低生产成本。
5. Assist the person in charge or supervisor to improve the process technology of the preparation buffer, purification and conjugation process to improve the product quality and yield.
协助负责人或主管改进缓冲液配制、纯化和偶联工艺的工艺技术，提高产品质量和收率。
6. Process and analyze production data, be familiar with deviation investigation, change control and CAPA follow-up.
对生产数据进行处理分析，熟悉掌握偏差调查，变更控制和CAPA跟进。
7. Responsible for internal and external audit communication and coordination, ensure that the communication information is correct and timely, including the use of English to smooth communicate with foreign auditors.
负责内部和外部审计的沟通和协调，确保沟通信息正确和及时的传递，包括熟练使用英语与国外审计人员顺利沟通。
8. Understand the relevant regulatory requirements of the pharmaceutical industry, be able to successfully interpret the English version of regulatory documents and carry out internal training on relevant requirements.
了解制药行业的相关法规要求，能够顺利解读英文版法规文件，并将相关要求进行内部培训。
9. According to EHS management requirements of the company, observe and supervise ADC production operators to do safety protection, and ensure the safety of personnel and equipment in ADC production area.
根据公司EHS管理要求，遵守和监督ADC生产操作人员做好安全防护工作，确保ADC生产区域人员和设备的安全。
10. Any other assignment as is determined by supervisor.
上级主管安排的其他工作