GMP USP Scientist
勃林格殷格翰生物药业有限公司ShanghaiUpdate time: August 2,2019
Job Description
Job Responsibilities
- The basic job profile covers mastering all USP(disposable) related technologies, including media preparation, inoculum, fermentation, harvest and IPC analytic.
- Responsible for the development of economic and robust purification processes for therapeutic proteins and monoclonal antibodies by applying state of the art technologies to ensure manufacturing of bulk drug substance.
- Routing cell culture from shake flask to single-use bioreactor to scale up cell culture for fermentation run, including media preparation, inoculum, fermentation, harvest and IPC analytic.
- Improving of current process based on QbD concepts, able to perform trouble shooting in USP.
- Thawing cell lines, working cell bank preparation.
- Contribute to tech transfer from Biberach or customer as part of the team.
- Present data, write report and communicate with the colleagues in Biberach.
- Maintenance of the lab, purchasing the consumables and equipment.
Qualifications
- Education/Degree Requirements: Master in Biopharmaceuticals, Biology, Biochemistry, Biotechnology, Bioengineering
- Solid Experience in Upstream processing(inoculums, scale-up, fermentation, harvest) and cell handling with good risk awareness.
- Theoretical & Practical experience with Process Controls and analytical technologies (e.g. cell metabolism, cell count, spectrometry).
- Basic QbD concept, familar with JMP software.
- Good command of English.
- Social competence, customer orientation and team player.
- Analytical and scientific thinking, clear argumentation and ability to reduce complex issues to the main points
职能类别: 药品生产/质量管理
关键字: GMP 生物制药 BIO CMO
微信分享
联系方式
上班地址:李时珍路257号
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