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无工作经验 -
硕士 -
招1人 -
11-09 发布
- 五险一金
- 免费班车
- 绩效奖金
- 定期体检
- 餐饮补贴
- 通讯补贴
- 交通补贴
职位描述
职位描述： Position Summary:?Responsible for small molecule or macromolecule bioanalysis in support of clinical studies. Communicate with clients, evaluate business opportunities and participate discussions with clients on LC/MS/MS based bioanalysis strategy including method development, assay transfer, validation and sample analysis.?Lead the method development and validation of LC/MS/MS assays used for clinical studies and products development. Ensure scientific integrity and GLP / ISO 13485 / CAP / GMP compliance.?Work/colleborate with Clinical Diagostics R&D team, Independent Clinical Lab and IVD GMP to deliver bioanalytical data to support clinical studies and IVD products development timely?Plan and provide immunology related training to staff as requiredKEY RESPONSIBILITIES?Accountable for all business and operational aspects pertaining to small molecule or macromolecule bioanalysis for clinical studies. Actively participle client visits, teleconferences to discuss client projects. Prepare proposals on bioanalysis method development, transfer, validation or sample analysis.?Serve as the technical expert in small molecule or macro molecule bioanalysis to establish LC/MS/MS based assays to ensure method transfer and new method development for supported projects?As studay director, ensure that (1) basic operation tasks are clearly defined, （2）staff assignment are appropriate for their level and capability, (3) assignments are completed within the timelines, (4) study personnel understand clearly their responsibilities and acknowledge relevant standard operating procedures (5) contingency plan is in place for unforeseen events that affects timeline and deliverables and the impact of any deviations from the study protocol and/or standard operating procedures on the quality and integrity of the study is assessed and recorded, and take appropriate corrective action if necessary, (6) Communicate effectively with the QA unit and address study related findings during the conduct of the study?Communicate effectively with other departments/function areas. Set priority for all projects and allocate appropriate human resources/work schedule to ensure timely delivery.?Plan and provide regular trainings to staff to ensure adequate training is provided to staff to execute the required work assignments.MINIMUM REQUIREMENTS?PhD or MS degree or equivalent in bioanalysis fields with 8 years of work experience in GLP LC/MS/MS area, or equivalent trainings/experience acquired through work in the fields?Hands-on experience in designing/conducting/monitoring clinical studies (GLP, GMP, ISO13485, CAP)?Expertise in LC/MS/MS techniques including knowledge of various MS and LC platforms especially ABSciex MS, Shimazu and Waters HPLC/UPLC, API 6500-Sturgeon)?Experience in managing GLP / CAP/ ISO 13485/ CAP laboratory and studies.?Fluent oral and written English skills. Oversea education and working experience highly preferred. 职能类别： 医药技术研发管理人员 医疗器械研发
联系方式
上海市外高桥保税区富特中路288号
公司信息
药明康德新药开发有限公司于2000年12月成立，是全球领先的制药、生物技术以及医疗器械研发开放式能力和技术平台公司，在中美两国均有运营实体。作为一家以研究为首任，以客户为中心的公司，药明康德向全球制药公司、生物技术公司以及医疗器械公司提供一系列全方位的实验室研发、研究生产服务，服务范围贯穿从药物发现到推向市场的全过程。药明康德的服务旨在通过高性价比、高效率的研发服务帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。 十多年来，药明康德成功打造了全方位一体化的研发服务技术平台。创建之初，药明康德凭借其在发现化学合成领域的雄厚实力实现了全面发展。近几年来，我们又新增了一系列一体化服务，包括分析服务、生物分析服务、工艺研究、工艺研发服务、API生产服务、药物代谢及其动力学服务、研发生物学、药理学、制剂、毒理学、基因组服务、生物制剂生产服务、抗体及生物诊断试剂的生产和销售服务以及临床研发和产品注册服务等。 从 2000 年 12 月创立至今，药明康德的员工数从4 人增长至 10000 人，实验室由当初仅有的一间增长到近46 万平方米已有及在建研发基地和生产厂房。与此同时，药明康德还在不断增强服务能力，拓宽服务领域，以更好地服务公司持续增长的全球业务需求。作为一家全球领先的医药研发服务公司，药明康德将继续致力于在中美两国为全球客户提供高质量的医药研发服务，帮助研发出更多造福患者的新药及产品。 回望昔年，药明康德已经走过了15年的历程。15年走来，我们见证了新药研发的飞速发展，见证了众多科学家在新药研发中实现梦想，见证了全球2000多家企业攻克越来越多的疾病，见证了越来越多患者脸上渐渐浮现的微笑，同时也见证了药明康德人从无到有将药明康德建成一个无论在亚洲还是在全球医药行业里独一无二的研发生产技术能力平台性公司。 未来我们的发展方向：一是继续将一体化、开放式的研发生产技术能力平台做大做强，继续延揽建立全球最尖端的医药研发技术，包括基因诊断、细胞基因治疗、基因编辑以及一些高端创新药物的研发、生产等。二是更加致力服务中国的大健康产业，通过我们的平台连接“人与健康”，让国际尖端医药技术能为广大国内患者和老百姓所用。 面对2016年，回归成为私营公司的药明康德将更加专注，专注于公司创业之初变革新药研发的梦想。不忘初心，方得始终。药明康德人将继续坚守我们的初心与梦想，在新的征程中，实实在在地推动人类健康。欢迎加入药明康德大家庭，与我们携手一起开启未来，创造未来，享受未来！ 如需了解更多，欢迎访问公司网站 http://www.wuxiapptec.com.cn
