[上海]Kite Pharma

公司官网:ww***com[点击查看] 职能类别:药品生产/质量管理

1. Conduct related daily testing and test method development,    such as microbe limit testing, sterility testing, endotoxin testing, TOC, Conductivity test;    执行日常的相关测试和检测方法的开发，如微生物限度检测，无菌检测，细菌内毒素检测，总有机碳，电导率测试
2. Conduct regular microbiological basic testing, such as media/dilution preparation, media growth promotion testing,    Gram staining, bacterial strain management;  执行相关微生物基本检测方法，如培养基配制、稀释，培养基促生长检测，革兰氏染色，菌种管理等；
3. Conduct cleanroom routine environmental monitoring;    执行洁净区域的日常环境监测；
4. Conduct plant purified water system routine monitoring;    执行工厂纯化水系统的日常监测；
5. Prepare test reports to support raw material/ product/ plant facility and other related material release;   准备支持原料、产品、厂房设施以及其他相关物料放行的相关报告；
6. All related lab activities must meet regulation requirements, like GMP, GLP;    所有相关的实验室行为必须符合相关法规要求,如GMP,GLP；
7. Draft QC related SOPs, including test SOP, management SOP,    and update these SOPs basing on the validation results or trend assay results    or regulation;   编写QC 相关的SOP，包括测试SOP,管理SOP，并根据验证结果或者趋势分析结果或法规及时更新相关SOP；
8. Complete position related trainings;    按时完成岗位相关的培训；
9. Order and maintain the consumables and reagents used in QC testing;    采购并管理环境监测所需的试剂耗材；
10. Operate QC    equipment, cooperate with relevant departments to conduct the equipment calibration and maintenance timely;    使用QC相关仪器，和相关部门合作及时实施仪器的校验和维护；
11. Cooperate with other department to conduct related    validations, draft protocols, perform the procedures, analyze and report the    results. Participate in related deviation/OOS investigations. Timely review the abnormal cases.    和其他部门合作进行相关的验证工作，编制方案，实施检测，分析并汇报结果。参与相关的偏差/OOS调查。及时回顾异常情况。

任职要求：

1. BS degree in biochemistry, microbiology, immunology, molecular/cell biology;     生物化学、微生物学、分子、细胞生物或其他相关领域学士学位；
2. Ability to analyze data, troubleshoot, train and work closely with other function;    具有数据分析、异常结果原因分析的能力，可以被培训并能够和其他部门同事共同合作；
3. Good written, interpersonal and communication skills are required.   良好的写作、团队合作及沟通技巧。

公司名称:Kite Pharma 公司类型:上市公司 公司介绍:"To bring about this transformation, we're developing innovative products that harness a patient's own immune system to target and attack cancer cells. In just three years, our singular focus and strategic collaborations, including multiple Cooperative Research and Development Agreements with the National Cancer Institute, have enabled us to advance an industry-leading pipeline of chimeric antigen receptor (CAR) and T cell receptor (TCR) product candidates to address both hematological (blood-based) and solid cancers. On October 3, 2017, Kite became a Gilead company with the completion of the acquisition by Gilead Sciences. "