上海招聘

This position is primarily responsible for supporting the analytical transfer used in the testing of cellular therapy products into Process Sciences. This position may serve as a process owner to drive small to medium scope continuous improvement projects and support Business Process Improvement activities related to overall department goals.

• Development, verification, validation, and continuous improvement of GMP-compliant analytical procedures including creation and maintenance of documents e.g. SOPs, development or validation protocols, development or validation reports.

• Participates in research and development activities to support internal and external clients/projects. Supports execution of studies in a laboratory setting, writes technical protocols and reports.

• Authors GMP documentation including test methods, specifications, protocols, reports, SOPs and change controls.

• Provides analytical support to identified internal business units with contracted GMP manufacturing projects.

• Troubleshoots analytical issues, including investigation for root cause (OOS) and implementation of corrective and preventive action (CAPA).

• Participates in internal meetings, reporting and presenting appropriate details to management as needed.

• Work with service engineering to ensure the QC instruments can be maintained and repaired timely. 

任职要求

• Master degree in a biological or biomedical or related disciplines.

• 2+ working experience in QC/analytical department of Biopharma.

• Progressive experience with clinical processing analytical testing in the cell therapy industry and/or cell culture operations in the biotechnology industry; or equivalent combination of education and experience, required.      

• Advanced understanding of relevant cell therapy characterization analytical methods, such as flow cytometry, ELISA and qPCR. Exposure to one or more advanced potency methods, such as cytotoxicity and/or cytokine characterization, preferred.

• Advanced understanding of cGMP and regulations/guidance. Can interpret guidance documents and make technical recommendations, preferred.

• Strong technical writing and communication skills, preferred.

• Expert understanding of analytical transfer, qualification, and validation, preferred.

• Advanced understanding of statistical methods applicable to analytical transfer and qualification, preferred.
  

德国美天旎生物技术有限公司成立于1989年，总部设于德国科隆，目前已经在25个国家设有分公司或代表处，拥有3000多名员工，其中包括600多名来自不同学科，如生物学、医学、物理学、机械工程等领域的优秀人才，组成了稳固的研发和技术服务团队。作为从基础科研到临床治疗完整产品线的专业的多元化公司，德国美天旎一直秉承“Researchers working for researchers”的理念，为基础科研和临床研究人员提供完整的解决方案。
自1989年公司成立以来，以专利的MACS磁分选技术享誉全球，成为磁分选领域内的金标准。公司注重不断开拓创新，产品线覆盖到生命科学研究的各个层面，包括组织处理及样本制备、细胞分选、细胞培养、流式细胞分析、分子应用和小动物成像。
2001年，德国美天旎设立中国代表处，目前美天旎中国总部位于上海，在北京、广州设有办事处。
我们的创新解决方案使得公司能够在生物医学研究、细胞治疗以及各种疾病的细胞基因治疗领域处于国际领先地位。
我们通过持续的和不断盈利的增长模式确保公司在本行业的领导地位。同时，我们忠实的客户也信任公司产品的高质量和创新的领先地位。
由于员工对公司持续奉献，我们为我们的员工感到自豪。