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5-7年经验 -
招1人 -
英语精通 -
11-09 发布
- 五险一金
- 免费班车
- 通讯补贴
- 年终奖金
- 定期体检
职位描述
职位描述： KEY ACCOUNTIBILITIES:1.Lead development or transfer of immunochemistry-based bioanalytical methods in PK, PD, Immunogenicity and biomarker areas.2.Serve as Study Director/Principle Investigator for method validation and clinical sample analysis studies. Ensure GLP compliance. Prepare/review study protocols and reports. Address QA findings and observations.3.Lead troubleshooting of issues occurred during method development or in-study phase.4.Participate client visits, teleconferences and provide project updates to clients.5.Manage lab operations and a group of 5-6 analysts. Provide training and mentor/develop team members.6.Interact with sample manager, bioanalyst, instrument scheduler, report writer, QC/QA, etc to track project progress and ensure on time delivery.REQUIREMENTS:1.Candidates must have strong scientific understanding of immunoassays. Demonstrated capability of developing assays independently. Experience with ELISA, MSD or Luminex are strongly preferred. Experience in cell culture, flow cytometry and cell-based assays is a plus.2.Must be trained in or have experience with the requirements of FDA GLP regulation, CFDA GLP regulation, and OECD GLP guidelines. Must be familiar with guidances/standards related to bioanalytical methods.3.Experienced in immunochemistry-based large molecule bioanalytical method development/validation.4.Strong communication skills and fluent in both written and oral English.5.Demonstrated good interpersonally skills and experience/ability to manage a GLP lab. Must be able to openly share information and work in a team setting. 职能类别： 医药技术研发管理人员
联系方式
吴中大道1318号
公司信息
苏州药明康德成立于2006年10月，是药明康德全资子公司，该设施面积达三万多平方米并且目前向全球客户提供符合GLP标准的遗传毒性实验服务，并通过了AAALAC的国际认证； SFDA的GLP认证；欧洲OECD的GLP认证；是全球唯一一家通过全面资质认证的药物安全性评价中心。 同时，苏州药明康德拥有众多获得资格认证的毒理学家和病理学家们，能够为国内外客户提供包括大小动物的急性毒性、长期毒性、药代/毒代、生殖毒性、安全性药理、遗传毒性等药物安全性评价项目以及体内外药物筛选、药理药效研究等临床前安全评价研究服务。
