体外诊断试剂生产经理/主管
广州燃石医学检验所有限公司
- 公司规模:1000-5000人
- 公司性质:民营公司
- 公司行业:制药/生物工程
职位信息
- 发布日期:2015-06-27
- 工作地点:广州
- 招聘人数:1
- 职位月薪:面议
- 职位类别:医疗器械生产/质量管理 医药技术研发管理人员
职位描述
岗位要求:医学、生物学相关专业硕士以上学历
职位描述:
1.具有三年以上GMP车间或洁净车间生产工作经验,具有两年以上生产线员工管理经验;
2.了解体外诊断试剂生产流程,可独立编制、修订SOP文件;有产品临床注册申报经验;
3.全面控制、协调生产部门的人员管理及各项生产活动;负责生产部人员技术培训、完善现有生产流程及工艺;
4.根据公司整体要求安排统筹产品生产、原材料采购计划、生产计划及产品售后反馈及信息收集等事务;
5.跟踪生产情况、产品需求、生产过程、产值目标等,指导并带领生产团队按时完成生产目标;对生产部门员工进行日常管理并予工作评价;
6.具备独立分析问题、解决问题的能力,及时对生产异常做出反应,能够发现问题及时追踪,并提出合理建议;
7.参与提高生产效率和改善产品质量的行动计划与实施
职位描述:
1.具有三年以上GMP车间或洁净车间生产工作经验,具有两年以上生产线员工管理经验;
2.了解体外诊断试剂生产流程,可独立编制、修订SOP文件;有产品临床注册申报经验;
3.全面控制、协调生产部门的人员管理及各项生产活动;负责生产部人员技术培训、完善现有生产流程及工艺;
4.根据公司整体要求安排统筹产品生产、原材料采购计划、生产计划及产品售后反馈及信息收集等事务;
5.跟踪生产情况、产品需求、生产过程、产值目标等,指导并带领生产团队按时完成生产目标;对生产部门员工进行日常管理并予工作评价;
6.具备独立分析问题、解决问题的能力,及时对生产异常做出反应,能够发现问题及时追踪,并提出合理建议;
7.参与提高生产效率和改善产品质量的行动计划与实施
公司介绍
关于燃石医学
燃石医学(纳斯达克代码:BNR)成立于2014年,公司使命为“用科学守护生命之光”,专注于为肿瘤精准医疗提供具有临床价值的二代基因测序(NGS)。公司业务及研发方向主要覆盖:1)基于NGS的肿瘤患病人群检测,6年间,燃石累计检测样本超过18.5万例,在中国市场份额领跑行业;2)基于NGS的癌症早检,目前已经进入临床验证阶段。
燃石医学于2018年7月率先获国家药品监督管理局(NMPA)颁发的中国肿瘤NGS检测试剂盒,在体外诊断领域具有里程碑式意义。实验室获得广东省临检中心颁发的 “高通量测序实验室”技术审核,以及得美国CLIA和CAP实验室质量体系资质认证。公司将继续致力于开发创新可靠的NGS检测产品,推动肿瘤精准医疗领域的发展。
About Burning Rock
Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to Guard Life via Science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, with the leading market share in China and over 185,000 tissue and liquid-based tests completed cumulatively, and ii) NGS-based cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.
In July 2018, Burning Rock received the first approval for a tumor NGS kit by the National Medical Products Administration (NMPA), which is a significant milestone in the field of in vitro diagnosis in China. Burning Rock’s laboratory has obtained the technical certification of “High-throughput sequencing laboratory” issued by Guangdong Center for Clinical Laboratory, and the CLIA and CAP laboratory quality system certification. The company continues to be committed to the development of innovative and reliable NGS testing products and promoting the development of precision medicine in oncology.
燃石医学(纳斯达克代码:BNR)成立于2014年,公司使命为“用科学守护生命之光”,专注于为肿瘤精准医疗提供具有临床价值的二代基因测序(NGS)。公司业务及研发方向主要覆盖:1)基于NGS的肿瘤患病人群检测,6年间,燃石累计检测样本超过18.5万例,在中国市场份额领跑行业;2)基于NGS的癌症早检,目前已经进入临床验证阶段。
燃石医学于2018年7月率先获国家药品监督管理局(NMPA)颁发的中国肿瘤NGS检测试剂盒,在体外诊断领域具有里程碑式意义。实验室获得广东省临检中心颁发的 “高通量测序实验室”技术审核,以及得美国CLIA和CAP实验室质量体系资质认证。公司将继续致力于开发创新可靠的NGS检测产品,推动肿瘤精准医疗领域的发展。
About Burning Rock
Burning Rock Biotech Limited (NASDAQ: BNR), whose mission is to Guard Life via Science, focuses on the application of next generation sequencing (NGS) technology in the field of precision oncology. Its business consists of i) NGS-based therapy selection testing for late-stage cancer patients, with the leading market share in China and over 185,000 tissue and liquid-based tests completed cumulatively, and ii) NGS-based cancer early detection, which has moved beyond proof-of-concept R&D into the clinical validation stage.
In July 2018, Burning Rock received the first approval for a tumor NGS kit by the National Medical Products Administration (NMPA), which is a significant milestone in the field of in vitro diagnosis in China. Burning Rock’s laboratory has obtained the technical certification of “High-throughput sequencing laboratory” issued by Guangdong Center for Clinical Laboratory, and the CLIA and CAP laboratory quality system certification. The company continues to be committed to the development of innovative and reliable NGS testing products and promoting the development of precision medicine in oncology.
联系方式
- Email:simin.huang@brbiotech.com
- 公司地址:广州国际生物岛星岛环北路5号(燃石医学)
- 电话:17710099363