Career | 组长—分析，QC（YM）

Career Opportunity 20170730-001-005

职位名称：组长—分析，QC

 

工作地点：上海

职位描述：

1. 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;
   

2. Define, implement, and manage the various quality control programs needed to ensure GMP/GLP and regulatory compliance;

3. Establish SOPs and LIMS and ensure sample testing and testing reports completed in a timely manner to meet the demands of all projects;

4. 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;

5. Keep all required instrument and equipment calibrated, validated if needed, and maintained in good conditions;

6. Hold regular communication with clients in written and oral formats;

7. Write and review technical reports and regulatory submission files;

8. Ability to manage multiple projects in parallel with different priorities;

9. Day-to-day team operation management.

任职要求：

1. Ph.D.1+ /MS 3+ years of working experience in biopharmaceutical development
   

2. environment with good track record in analytical development and quality control is required;

3. Oversee all analytical laboratory procedures and related testing, data review, trending, interpretation and reporting of results; 

4. Oversee analytical (protein) and microbiological in-process, release and stability testing and the environmental monitoring and raw material programs;

5. Coordinate cross-functional, intra-group and inter-group work assignments and address scheduling conflicts;

6. Provide guidance on the resolution of EMIs, deviations, OOS and CAPAs;

7. Oversee and lead problem solving and troubleshooting; identify and resolve technical testing issues; review and approve investigation reports;

8. 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;

9. Oversee the EM trending and publish quarterly and annual reports;

10. Ensure proper transfer and validate QC methods;

11. Fluent communication in both English and Chinese.

如何申请：

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