Scientist II, Global Technical Operations

Added
5 days ago
Type
Full time
Salary
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Related skills

gmp regulatory submissions process validation cross-functional communication tech transfer

📋 Description

  • Resolve key project hurdles using technical expertise; support late-stage/commercial biologics
  • Work in dynamic/diverse team to support & troubleshoot current commercial manufacturing
  • Support/lead new product introduction at AbbVie sites or third-party manufacturers; ensure
  • Support CMC life-cycle management and post-approval continued process validation for commercial
  • Collaborate with process development on late-stage tech transfers, scale-up, and validation during
  • Support product investigations/non-conformances; identify root causes; make scientific/quality

🎯 Requirements

  • B.Sc. + 7+ years, OR M.Sc. + 5+ years relevant experience in Biology, Biochemistry, Chemical or
  • Demonstrated experience with biologics DS operations
  • Knowledge of GMP
  • Effective writer/communicator of research or regulatory materials
  • Demonstrated ability to lead and influence cross-functional teams
  • Strong analytical skills
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