Full Time

QC Manager

Posted 2 months ago
Application ends: October 27, 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

  • Manage overall product QC, including physiochemical, biochemical and cellular function analysis group.
  • Lead QC method transfer, method validation and continual method performance monitoring.
  • Lead QC submission document preparation for IND and NDA.
  • Manage biologics stability center and lead study design, execution and data application for routine stability, in-use stability and shipping stability, and other exploratory studies.
  • Lead biologics specification setting and updating.
  • Lead release and stability comparability study.
  • Lead reference standard and critical reagent management.

Qualification Required

  • Experienced and deep understanding of biologics analytical method development, method validation/transfer and relevant regulatory requirements.
  • Experienced and good understanding of biologics potency assay, comparability, compatibility and in-use stability, cell bank characterization, leachable and extractable study, stability, specification setting, expiry dating, and other CMC regulatory and compliance strategies.
  • Experienced and deep understanding of ICH Q series, GDP, Data integrity, and GMP requirements.
  • Well-educated and broad-minded in both specific area and general science.
  • Good communication skills in both Chinese and English.

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