Process Development Upstream Bioprocess Senior Engineer (m/f/d)

  • Apply a fundamental understanding of mammalian cell culture operations to support commercial manufacturing processes: Scale up of cell culture, Single Use Bioreactors, Perfusion and Harvest technologies
  • Use comprehensive understanding of chemical engineering principles for the scale up of unit operations from bench to commercial scale
  • Provide technical leadership in solving clinical and commercial drug substance process issues involving equipment, scale, and raw materials
  • Evaluate process capabilities to develop and implement process and yield improvement opportunities
  • Partner with the Process Development laboratories to design experimentation to support process scale up
  • Perform technical review of data, and author and review GMP documentation
  • Execute technology transfer projects to support Amgen Network initiatives. Provide floor support during clinical and validation runs
  • Academic background in Chemical Engineering, Bioengineering or Biotechnology
  • 6+ years of experience in drug substance process development, characterization and commercial process support
  • Possess advanced understanding of regulatory and cGMP requirements
  • Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements

» Job description

Amgen Ltd.
Rhode Island [USA]