Process Development Senior Engineer (m/f/d)

  • design and implementation of characterization studies for multiple parenteral modalities
  • assessment of product impact from manufacturing process, production scale, equipment, and raw material changes
  • author high-quality process technology transfer and other technical documents
  • participate in authoring relevant sections of regulatory submissions to enable successful introduction of new processes and/or production facilities across the parenteral portfolio
  • M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related field of study
  • 5+ years of drug product process development experience in the pharmaceuticals/biotechnology industry
  • Familiarity with aseptic processing, drug product manufacturing, cGMPs, statistical design, analysis of experiments, and process characterization
  • Fill/finish process scale-up and technology transfer experience including the use of gap analysis, root cause analysis, and risk assessment tools

» Job description

Amgen Ltd.
Cambridge [USA]