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BiogenPosted 2 months ago

China Production Lead

On-siteShanghai, Shanghai, China

Full TimeSenior LevelLarge

Job Summary

China Production Lead provides end-to-end leadership and oversight for external manufacturing operations in China, coordinating production supply planning, technology transfer, process validation support, on-site monitoring at CMO/CDMO partners, and release/testing interfaces with Quality Operations. Oversees deviation/change management, lifecycle management, and distribution activities to ensure safe, compliant, and timely supply of drug substance, drug product, and finished goods. Serves as senior production representative within the Market Authorization Holder framework, leads cross-functional decision-making, risk and escalation management, and reports to the Regional PO&T Lead. Builds capability across Technical Development, Quality, Regulatory CMC, and Supply Chain, driving operational excellence and readiness for inspections and continuous improvement. Qualifications include a bachelor’s degree in relevant sciences and 10+ years in pharmaceutical/biotech manufacturing with leadership experience; professional proficiency in English and Chinese.

Required Qualifications

  • Bachelor’s degree in pharmaceutical sciences
  • chemical engineering
  • bioprocess engineering
  • biotechnology
  • or related scientific discipline
  • Typically 10+ years of relevant pharmaceutical or biotechnology industry experience in manufacturing, process sciences, technical operations, or external manufacturing
  • significant experience in biologics and/or sterile products
  • Demonstrated leadership experience in complex, regulated manufacturing environments
  • Professional proficiency in English and Chinese (written and spoken)

Desired Qualifications

  • Bachelor’s degree in pharmaceutical sciences
  • chemical engineering
  • bioprocess engineering
  • biotechnology
  • or related scientific discipline
  • Typically 10+ years of relevant pharmaceutical or biotechnology industry experience
  • leadership experience in complex, regulated manufacturing environments
  • proficiency in English and Chinese (written and spoken)

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