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

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上班地址:李时珍路257号

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