Full Time

MST Purification Manager MST纯化经理

Posted 2 months ago
Application ends: November 3, 2021
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Job Description

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description

  • Complete all training and on-boarding work required by the company.
  • Obtain access to work needed tools such as Veeva, SAP, Docusign, Workday, Zoom and LMS, etc.
  • Veeva, SAP, Docusign, Workday, Zoom和LMS等的操作权限。
  • Be familiar with MSAT team members, department structure and roles, lab procedures, and document system. Be familiar with colleagues from departments such as DS, QA, QC, CMC.
  • MSAT团队成员,部门结构和角色,实验流程和文档体系。熟悉DS, QA, QC, CMC等部门同事。
  • Assist MFG batch runs, ensure all defined downstream samples are taken.
  • Perform MBR review for WCB3 batch, complete PM, assist deviation discussions, and be able to set up zoom meetings.
  • MBR审核,完成该批次工艺监测,协助偏差讨论,能够熟悉使用Zoom发起电话会议。
  • Assist in pilot run preparation for manufacturing and other projects as instructed by the MSAT downstream team.
  • MSAT下游团队的指示,协助生产部门项目和其他项目试运行准备。

完成上级安排的其他工作。 Any other assignment as is determined by supervisor.

Qualification Required

  • BS/MS/PhD of Pharmacy, Biology, Chemistry, or related field.

药学、生物学、化学或相关专业本科、硕士或博士学历

  • More than 6 years’ experience in Bio-pharmaceutical industry including more than 5 years’ GMP experience.

6年以上生物制药行业工作经验,其中超过5年GMP相关经验

  • GMP要求,具有处理偏差、变更控制、CAPA及相关事件的经验。
  • Experience in purification production ranging from pilot scale to production scale.
  • Familiar with downstream purification technology, including depth filtration, chromatography, virus filtration and ultrafiltration technology.
  • Familiar with the regulations and guidelines of NMPA and ICH.
  • ICH的相关法规和指南。
  • Good teamwork spirit, good interpersonal skills, and team management ability.

良好的团队合作精神,良好的人际关系和团队管理能力。

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