职责描述
Job description
1 协助搭建平台细胞建库体系，撰写中英文SOP等GMP体系文件。Assist in cell banking start-up; Draft SOP and other GMP documents.
2 按照GMP细胞建库生产计划，独立执行细胞培养和建库项目，完成生产任务，并完成批生产记录。 Perform cell banking projects independently following GMP cell banking schedule; Complete cell banking tasks and batch records.
3 执行项目或平台相关偏差调查工作、变更实行及纠正和预防措施的。Draft project or platform Deviations、Change controls、CAPAs.
4 参与部门自动化、电子化等新技术开发。Participated in developing automation and digital technologies.
5 具有较好的沟通能力，配合质量管理体系完成方法开发和技术转移；适应跨部门合作，协同技术管理，法规管理和运营管理部门制定和完善标准规范；
Good communication skills and cooperating with the quality management system to complete method development and technology transfer; Adapt to cross-functional cooperation, cooperate with research, regulatory and operation departments to formulate and improve standards and specifications.
任职资格
Qualifications
1 学历要求：细胞生物学，生命科学，生物技术，生物工程，药学专业本科或以上学历
Education requirements: Bachelor degree or above in cell biology, life science, biotechnology, bioengineering or pharmacy
2 工作经验：0-5年细胞培养相关或细胞库建库经验，熟悉生物行业的技术发展，对于生物药物市场有较好认识
Hands-on background: 0-5 years of experience in cell culture or cell banking. Be familiar with the technological development of the biological industry and have a good understanding of the biological drug market
3 技能/技巧：具备GMP经验者优先
Skills/Techniques: GMP experience is preferred
4 工作态度：逻辑分析能力，沟通能力，组织协调能力强
Work attitude: Excellent logical analysis ability, communication ability, organization and coordination ability
5 其他特殊要求：英文读写能力良好
Other special requirements: Excellent English reading an