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上市药企招聘生物药工艺总监/SD/ED

吴红岩 医药荐客 2024-03-18
公司背景:国内大型上市医药公司
工作地:上海
下属团队:30-40人

Head of Biologics Process Development

Our team is seeking an exceptional leader to lead a team of passionate scientists to support biological drug substance process development activities to enable and accelerate early and late-stage pipeline programs .
What you will do
  • Responsible for designing and implementing novel upstream and downstream process platforms (e.g., intensified, continuous) that produce high yields with superior product quality and reduced COGS
  • Build robust lab scale biologics process models with QbD framework to support scale up, tech transfer, and process characterization
  • Champion and drive maturation of workflow improvement to enable fast program progression to IND
  • Proactive resource planning to enable predictable project outcome
  • Managing cross-functional interactions with other teams with external teams including commercial manufacturing
  • Partner with the  leadership team to advance the organizational capabilities and to enable effective technical and pipeline decision making
  • Focus on team/talent development to forge an innovative, science driven, and enjoyable working culture
  • Provide support for regulatory filing, inspection, due diligence, and other CMC related activities
What we expect of you
  • PHD and 6 year+ experience in biologics process development and related fields
  • Strong expertise in mammalian cell culture or purification process development or both, technical transfer of clinical and/or commercial processes
  • Deep understanding of QbD framework including Critical Quality Attributes and Control Strategy
  • Knowledgeable in regulatory filings and inspections.
  • Experience developing team/individuals to reach their full potential
  • Possess innovative mind set yet pragmatic approach
  • Fluent in both Chinese and English (verbal and writing) 
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