岗位描述
岗位职责:
在一定监督下于cGMP生产中执行相应蛋白纯化操作。具体操作工序包括但不限于:层析柱装填,蛋白纯化工序(层析,病毒灭活,深层过滤、除病毒过滤、超滤和原液分装)。
The corresponding protein purification operations are performed under the certain supervision in cGMP production. Specific operational processes include but not limited to column packing, protein purification process (chromatography, viral inactivation, depth filtration, virus filtration, ultrafiltration & diafiltration, and bulk fill).
主要设备操作包括但不限于:AKTA层析系统,深层过滤系统,超滤系统,除病毒过滤系统,蛋白浓度检测设备,衡器设备等。
The major equipment operations include but not limited to AKTA chromatography system, depth filtration system, ultrafiltration & diafiltration system, virus filtration system, protein concentration detection equipment, weighing equipment, etc.
参与不锈钢系统的操作,包括但不限于不锈钢系统CIP, SIP, 工艺操作等。
Participate in the operations of stainless steel system, including but not limited to CIP, SIP and process operation, etc.
参加修订/创建/复审诸如SOP、MBR、验证/资格认证协议类的cGMP文件和FAT/SAT文件
Participate in revision/creation/review of cGMP documents and FAT/SAT documents such as SOPs, MBRs, validation/qualification protocols
参加cGMP培训并遵循cGMP规则
Attend cGMP training and follow cGMP rules
参与FAT(工厂验收试验)和/或SAT(实地验收试验)和/或IOPQ(安装/运行/性能验证)
Participate in FAT (Factory Acceptance Test) and/or SAT (Site Acceptance Test) and/or IOPQ (Installation/Operation/Performance Qualification)
能够阅读/理解cGMP的中英文文件,并在工作中应用英文进行文件起草和GDP错误修改
Be able to read/understand cGMP documents in Chinese and English and apply English for drafting documents and correcting GDP error in the work
Requirements
本科及以上;生物化学、生物制药、生物工程、发酵、纯化等专业尤佳
College degree or above; Biochemistry, biopharmaceutical, bioengineering, fermentation, purification majors are preferred 30%
有一年及以上相关生物制药行业GMP工作经验和大分子生物制药不锈钢操作经验者优先考虑
One year or more of GMP work experience in the biopharmaceutical industry and experience in stainless steel operation of macromolecular biopharmaceuticals is preferred
英语四级及以上优先考虑
CET-4 or above is preferred
精神面貌良好,有激情,有活力,能够主动学习,并且快速应用学到的技能
Good mental outlook, passionate, energetic, ability to learn actively and apply the skills learned quickly