广州招聘

职位描述：
负责运用基因重组技术、细胞培养和生物技术净化技术制造供临床和商业启动的细胞疗法产品和关键起始物资。主要职责有：
Full time position manufacturing cell therapy products and their key starting materials using recombinant gene technology, cell culture, and biotechnology purification methods for clinical and commercial launch products. The major areas of responsibility are:
1. 按标准流程制造细胞治疗产品和关键起始物资
Manufacturing cell therapy products and key starting materials in compliance with standard procedures.
2. 能按要求在工作时间穿着洁净服
Following complex instructions whilst wearing cleanroom garments for extended periods.
3. 按照GMP要求遵守公司的安全流程，特别是精确的记录和卫生管理
Follow Good Manufacturing Practice (GMP) with particular emphasis on accurate records and hygiene and comply with company safety procedures.

主要职责ESSENTIAL FUNCTIONS
主要职责包括但不限于：Essential functions include, but are not limited to the following:
? 工厂安全Safety
o 主动积极并遵循公司政策流程确保公司设施安全运行
Contributing to the safe operation of ICT facilities through personal initiative and adherence with Company procedures.
o 实现零损失工时事故
Zero lost-time injuries
? 生产Production
o 协调预定和发给试剂和消耗品
Coordinate ordering and issue of reagents and consumables.
o 遵循和提高实现无菌操作的标准运营流程以高度的个人和操作卫生标准降低产品污染的风险
Observed high level of personal and operational hygiene to minimize risk of product contamination by following and identifying opportunities for improvement of Standard Operating Procedures to achieve aseptic operation.
o 严格遵守标准流程在分类洁净室生产关键起始物资（包括DNA质粒和重组病毒）和细胞治疗产品，包括在洁净室里穿着洁净服
Accurately follow standard procedures to produce key starting materials (including DNA plasmids and recombinant virus) and cell therapy products in classified cleanrooms. This will involve extended periods of concentration working in classified cleanrooms wearing cleanroom garments.
o 清洁和维护工艺设备、仪器和生产区域
Clean and maintain process equipment, instruments, and production areas.
o 协助主管和经理编制生产部门的绩效报告
Assist Supervisors and Managers to compile performance reports for the production department.
? 质量Quality
o 编制标准操作流程和相关记录
Write Standard Operating Procedures and associated records that accurately capture work practices
o 遵循文档管理规范精确简明地完成批记录和表格以存档生产运营文件
Neatly and accurately complete batch records and forms to document production operations following Good Documentation Practice.
o 报告偏差、CAPA等的质量问题并按要求执行解决方案
Report Quality Events including Deviations and CAPA and work to quickly implement approved actions.
o 遵守公司质量管理系统
Comply with company Quality Management System.
? 综述 General
o 及时完成分配的培训并运用到工作中。培训包括生产工艺、GMP和业务流程
Complete assigned training on time and apply learning in practice. This includes training in production processes, Good Manufacturing Practice, and business processes.
o 能团队合作也能靠自己的能力解决技术问题提高生产效率
Work with colleagues and as an individual contributor to solve technical problems and improve production efficiency.
o 记录项目工时，提交月报
Keep accurate records of time and projects (timesheet) and prepare a written monthly report of activities.
o 轮班工作，并能在节假日和周末工作
Work on shift, public holidays, or weekends.
o 积极鼓舞团队士气
Contribute positively to team morale.
o 完成主管或经理布置的项目任务
Complete minor project assignments as directed by Supervisors and Manager.
o 须通过能处理人血为基础的药物的考试
Must pass physician examination allowing handling of human blood-based medicines.
任职资格
有至少3个月的实习或***经验
Minimally require three month’s professional work as intern or the equivalent part-time experience.
理解生物技术和基础化学
Sound understanding of biology and basic chemistry.
理解书面英语，达到CET-4级水平
理解生物技术和基础化学
Sound understanding of biology and basic chemistry.
理解书面英语，达到CET-4级水平
Basic understanding of written English to CET 4 level required.
诚实，可信赖，能精准地完成布置的工作Honest and dependable to complete assigned tasks fully and accurately
工作条理清晰，有计划性 Neat and orderly with preference to work in highly organized way.
有抗压性Able to deal with stress of working with high accuracy for extended periods
务实Grounded and practical attitude.
能重复处理同一项工作任务并设法完美完成Enjoy repeating and mastering complex activities to achieve excellent results.
能同时进行多项任务Able to multi-task.
对细胞培养和生物技术生产有热情Enthusiasm for cell culture and biotechnology production. 举报 分享

上海斯丹赛生物技术有限公司定位于成为全球细胞治疗及再生医学领域的领航者，致力于服务科技创新和人类健康，在细胞治疗和基因编辑等领域，共递交专利申请多项并多次发表国际水平文章，在CAR-T细胞治疗领域中已走在行业前列。针对难治复发性白血病完全缓解率达85%，达到国际领先水平。在治疗淋巴瘤患者中取得了显著的临床效果，同时实体瘤的研发也已进入临床阶段。斯丹赛现已开始布局全球化战略，同时向中美两国递交了注册申请，已获批中国药监局临床试验，并已开展药物临床试验。公司计划两年内完成纳斯达克上市。