职责概要：参与细胞培养工艺开发相关工作。



岗位职责：



参与上游工艺开发平台的建立；

负责上游工艺开发的相关工作，包括工艺开发、工艺优化、中试放大等；

参与200L细胞培养，包括物料准备、生产相关文件撰写等；

负责研发到生产的技术转移，保证工艺平稳交接；

负责上游工艺表征研究；

按照规范要求填写各种使用记录、实验记录等相关文件，保证实验数据的完整性；

负责IND上游工艺开发相关申报资料的准备和撰写；

负责上游工艺开发实验室设备的日常保养及维护；

遵守实验室各项合规制度，维护良好的实验室卫生及安全环境；

完成上级领导分派的其他相关工作，并及时汇报工作进度及安排。



任职要求：
生物化学，生物工程及制药等相关专业研究生以上学历；

1年以上上游工艺开发经验；有中试放大经验者优先；

对QBD和DOE理论有一定的了解；

工作积极主动、严谨细致、责任心强、有良好的沟通能力及团队协作意识；具有一定的抗压和学习能力；

熟练使用各种office办公软件，较好的英文读写能力。



Job Summary:

The candidates will participate in Cell Culture process development.

Responsibility：



Participate in the establishment of upstream process development platform.
Responsible for upstream process development including process development, process optimization, pilot scale-up, etc.
Participate in 200L cell culture, including material preparation, production related documents writing, etc.
Participate in technical transfer from PD to manufacture.
Responsible for characterization study of upstream process.
Fill in all kinds of use records, experimental records and other relevant documents according to the specification requirements to ensure the integrity of experimental data.
Participate in preparation and writing of upstream process development related files for IND.
Responsible for daily cleaning and maintenance of upstream laboratory equipments.
Comply with all compliance systems of the laboratory and maintain a healthy and safe laboratory environment.
Complete other related work assigned by leader, and report work progress and arrangement in time.


Qualification:



1. Master degree or above, major in Biochemistry, Bioengineering, Pharmacy and other related fields.



2. At least 1 year experience in upstream process development and experience in pilot scale-up production is preferred.

3. Basic understanding of QBD and DOE theory.



4. Proactive, rigorous and meticulous, strong sense of responsibility, good communication skills and sense of teamwork; Able to work under pressure resistance and quick at learning.

5. Familiar with office software, good at English reading and writing.