质控主管(生物检测相关)
JD/岗位描述:
• Test, qualify and validate all bioassay including potency, cell activity, and ELISA based etc., QC tests under GMP system
遵照GMP体系,进行生物检测,包括有效性,细胞活性和ELISA(酶联免疫吸附测定)
• Establish standard operating procedures (SOP) and methods
•建立标准操作流程和方法
• Cell bank management.
•细胞库管理
• Manage and audit of third party contract providers for outsource laboratory services in bioassay functional areas.
对于第三方外包服务的生物检测实验室进行管理和审计
Requirement/岗位要求:
•Master or bachelor degree in a related scientific discipline (or equivalent scientific experience if all other criteria are met), with 2-4 years’ experience.
•硕士或本科相关学术专业(或在本学科领域有相关工作经验?),3年以上工作经验。
•Experienced in cell base assay, experienced in flow cytometry will be priority
•具有丰富的细胞相关分析经验,有流式细胞仪操作经验者优先
•Experience in pharmaceutical GMP facility will be priority.
•有生物制药GMP实验室工作经验者优先
• Independently plans and completes testing, data ****uation and reporting.
•独立计划和完成实验,数据评估和报告。
• Identifies suspect data and works with management to complete an investigation.
•识别可疑数据,协助主管完成检测研究工作。
全球细胞治疗领航者,致力于服务科技创新和人类健康事业。
在细胞治疗、干细胞和基因编辑等领域,公司技术上达到了国际领先水平,获得了多项国际、国内发明专利,目前在细胞治疗领域中已走在行业前沿。
专利产品已出口美国、英国、德国、法国、日本等发达国家。
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