南京招聘

工作职责:

1. Act as a project leader to prepare study protocol/plan, methodology, schedule study progress, approve bioanalytical study results, conduct experiments and report data under study protocol/plan, SOP, GLP and other regulations.

2. Be the single point control of bioanalytical study and have overall responsibility for the scientific, technical and regulatory compliance of assigned studies.

3. Communicate with sponsor’s study monitor and provide project updates regularly.

4. Interact with internal function teams to ensure the completion of the project smoothly.

5. Review and approve analytical data for analytical run acceptability based on study protocol, methodology file and SOPs.

6. Address QA findings and approve study-related deviations. Perform impact evaluation for deviations and unforeseen events.

7. Troubleshoot technical issues occurred in the assigned study.

8. Prepare and approve final report.

9. Conduct work described in the related SOPs and according to OECD, USFDA and CFDA, etc., GLP guidelines as well as other applicable regulations.

任职资格:

1. MS degree in a science discipline with experience or training in chemistry, pharmacy, biology or other relevant fields or equivalent experience.

2. Strong communication skills, including reading, written and verbal and outstanding interpersonal skill are essential job requirement.

3. Must be able to openly share information and work in a team-oriented manner in order to accomplish performance objectives.

4. Be skillful at reading, understanding and writing English documentation.

5. Be proficient in biological sample pre-treatment methods including but not limited to protein precipitation, liquid-liquid extraction and solid-phase extraction.

6. Have experience with analytical techniques, particularly immunoassay.

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