Career Opportunity 20170730-001-005
职位名称：组长—分析，QC
工作地点：上海
职位描述：
Lead a team of scientists and associates to develop analytical assays and conduct assay validation and testing for therapeutic protein for various research and manufacturing stages;
Define, implement, and manage the various quality control programs needed to ensure GMP/GLP and regulatory compliance;
Establish SOPs and LIMS and ensure sample testing and testing reports completed in a timely manner to meet the demands of all projects;
Manage and coordinate the activities of the department in support of biopharmaceuticals produced in the cGMP facility including: oversight of analytical (protein) and microbiological in-process, release and stability testing, the environmental monitoring and raw material programs; deviation investigation and guiding in potential CAPAs; draft and revise SOPs; staff training and development;
Keep all required instrument and equipment calibrated, validated if needed, and maintained in good conditions;
Hold regular communication with clients in written and oral formats;
Write and review technical reports and regulatory submission files;
Ability to manage multiple projects in parallel with different priorities;
Day-to-day team operation management.
任职要求：
Ph.D.1+ /MS 3+ years of working experience in biopharmaceutical development
environment with good track record in analytical development and quality control is required;
Oversee all analytical laboratory procedures and related testing, data review, trending, interpretation and reporting of results;
Oversee analytical (protein) and microbiological in-process, release and stability testing and the environmental monitoring and raw material programs;
Coordinate cross-functional, intra-group and inter-group work assignments and address scheduling conflicts;
Provide guidance on the resolution of EMIs, deviations, OOS and CAPAs;
Oversee and lead problem solving and troubleshooting; identify and resolve technical testing issues; review and approve investigation reports;
Devise, implement and maintain quality control programs to ensure reliability of testing procedures, proper function of laboratory equipment, compliance with federal regulations, prepare and maintain applicable records;
Oversee the EM trending and publish quarterly and annual reports;
Ensure proper transfer and validate QC methods;
Fluent communication in both English and Chinese.
如何申请：
请将您的简历发送到 drugtimes@qq.com. 请在主题栏注明 "Career Opportunity 20170730-001-005" 。
衷心感谢！
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