?1.Supervise the Company Environmental Monitoring Program to include system implementation,  Facility Qualification, on-going monitoring (sampling, testing, trending).

?2.Responsible for antibody and protein drugs physical and chemical analysis, activity analysis and the analysis method of establishment and validation of impurities (including but not limited to HPLC, CE, limited detection, protein ultraviolet spectrum identification, determination of moisture and osmotic pressure, bacterial endotoxin detection, etc.);

?3.Provide support within the Quality Control department for the testing and evaluation of environmental monitoring, product, in-process, and raw material samples.

?4.Lead, coach and develop the Quality Control Laboratory team, review colleagues’ performance, set and communicate objectives, priorities, metrics, development plans and conduct performance assessments.Lead and manage the laboratory testing for Analytical Chemistry, Biochemistry, Viral & Safety, Technical Services, and Senior Technical staff.

?5.Align with corporate Quality processes and IT systems such as product testing, CAPA, lab investigations, stability testing, LIMS, lab equipment calibration providing support to QC Systems.

?6.Take a lead role in providing guidance and support on failure investigations and resolution of OOS investigations ensuring staff development in this area.

?7.Ensure that documentation and laboratory processes are in a constant state of regulatory compliance and inspection readiness

?8.Author/Contribute to CMC sections of Annual Progress Reports and Annual Product Reviews

?9.Manage performance and development of direct reports providing regularly scheduled feedback throughout the year to ensure achievement of organizational and department goals and a productive environment.

?10.Proactively use scientific literature and guidelines to solve problems.

?11.Ensure test methods are qualified/validated to support production of products for clinical or commercial use.

?12.Identify and interact with outside manufacturers and contract test labs. Provide complete data analysis and be able to drive projects to completion using data generated in the design of new experiments and/or critical assessment.

?13.May contribute to sections of regulatory submissions (primarily IND, BLA etc.).


?1.Master’s degree with 6+ years’ experience. Or PhD with 4+ years’ experience in biotechnology induction in which 4+ years’ in quality managerial position. Medicine, biological analysis, analytical chemistry, biochemistry and other related professional;

?2.Thorough knowledge of GMP regulations and documentation.

?3.Ability to train others in the application of GMP. Ability to manage multi-disciplinary teams.

?4.Excellent verbal and written communication skills; able to communicate in English

?5.Experience in directing and leading successful quality control laboratory functions to achieve regulatory approval









8.协助公司向法规部门(IND, BLA等)提交产品注册资料。


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