职责概要：



负责车间下游生产相关工作。



岗位职责：

负责按cGMP要求进行层析、纳滤、超滤、层析柱装填/拆卸等生产工艺操作；
负责SOP/MBR/URS等文件的起草/升版，参与下游生产相关设备的FAT、SAT、IQ、OQ、PQ；
负责按cGMP要求进行洁净区内的清洁消毒工作，如周期清洁、清场清洁和设备表面清洁等；
参与原辅料及耗材的采购，跟踪，管理等；
参与下游生产相关设备的验证，校验，维护，管理等；
参与偏差的发起调查，相关变更及CAPAs执行。


任职资格：



1. 大学专科及以上学历，生物医药及相关专业毕业；



2. 具有cGMP生产的相关知识或经验，有3年及以上工作经验者优先。



3. 熟悉抗体下游生产工艺及设备；



4. 熟悉生物药GMP法规要求；



5. 良好的沟通、计划和执行能力；有责任心，能够承受挑战性工作的压力。



6. 英语流利优先；





Job Summary:



The candidate will be responsible for downstream production related work



Responsibility：



1. Responsible for chromatography, nanofiltration, UF/DF, column packing/unpacking and other process operation per cGMP requirement;



2. Responsible for the draft/revision of SOP/MBR/URS and other documents, Participation in FAT、SAT、IQ、OQ、PQ of relevant downstream production equipment;



3. Responsible for cleaning in the clean area per cGMP requirement，such as periodic cleaning，changeover cleaning and equipment cleaning, etc;



4. Involving in ordering, tracking, managing the raw materials and consumables;



5. Involving in the qualification, validation, calibration, maintenance and management of the process equipment/instruments;



6. Involving in the initiation and investigation of deviation，and implementation of change control and CAPAs.



Qualification:



1. College degree or above, biochemical or related major;



2. Knowledge in GMP production about chromatography, UF/DF etc, and with three years or above experience is preferred.



3. Familiar with the downstream production process and equipment of antibodies;



4. Familiar with GMP regulations for biological drugs;



5. Good communication, planning and execution ability; Responsible and able to work under pressure.



6. Fluent English is a plus;