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职位信息

职位信息
MSAT - Upstream/Downstream Leader, Sr. Engineer to Associate Director
May. 17, 2021
MSAT - Upstream/Downstream Leader, Sr. Engineer to Associate Director
中国
无锡
工作职责:
  • This position is in the Manufacturing Science and Technology (MSAT) Department of WuXi Biologics.  
  • The successful candidate will undertake or lead all activities in early and late stage technology transfer, process validation, process monitoring and continued process verification (CPV), and take part in Quality System support and improvement. 
  • The successful individual will participate in all CMO project team activities, and potentially direct the efforts of junior MSAT staff with the intention of supporting manufacturing campaigns to produce clinical phase II & III and BLA-enabling materials.  
  • The successful candidate is expected to work routinely with teams within the cGMP Manufacturing organization (Drug Substance MFG, Drug Product MFG, Process Engineering & Validation, Automation, Engineering, QA, QC) as well as to collaborate with other cross-functional teams including CMC, Project Management (PM), Process Development, and Analytics and Formulation Development.
任职能力:
  • Minimum a 4-year college degree in the area of Biochemistry, Biological Sciences, or Biochemical/ Chemical Engineering.  Previous Biotech industry experience is desirable.   
  • Ph.D. with 4+ years of proven experience and accomplishment
  • M.S. with 6+ years of proven experience and accomplishment
  • B.S. with 8+ years of proven experience and accomplishment
  • Meet either condition (as 1 or 2)
  • Required specialized skills include a deep conceptual understanding of cell culture principles and a thorough knowledge of media and feed development, cell culture techniques, small and large scale processing equipment, and cGMP. 
  • Required specialized skills include a deep conceptual understanding of separation principles and a thorough knowledge of recovery separation and purification techniques, analytical assays, small and large scale processing equipment, and cGMP. 
  • The successful candidate should possess good problem-solving abilities and organizational and documentation skills with a strong focus on details and results.  
  • The successful candidate should be self-motivated and able to work independently as well as in a team environment.  
  • This individual should be a strong team player and have excellent written and oral presentation skills.  
  • luency in English writing and speaking is a plus.  The position requires leadership skills for direct reports as well as cross-functional teams.