2021届-生物分析研究员(J14640)
上海药明康德新药开发有限公司
- 公司规模:10000人以上
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2020-11-06
- 工作地点:上海-浦东新区
- 招聘人数:若干人
- 工作经验:在校生/应届生
- 学历要求:硕士
- 职位月薪:0.8-1万/月
- 职位类别:生物工程/生物制药 药品生产/质量管理
职位描述
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.
公司介绍
联系方式
- Email:zhuyun@wuxiapptec.com
- 公司地址:江北新区华康路122号南京生物医药谷加速器四期07栋
- 电话:15738851478