Engineer, Drug Product Process Engineering

Role Summary

Engineer, Drug Product Process Engineering. The engineer will contribute to drug product process development, commercialization, and lifecycle management of Amgen’s parenteral product portfolio, operating in product/process development and aseptic manufacturing environments. Based in Thousand Oaks, CA; primarily first shift with potential on-call during second or third shifts.

Responsibilities

• Work with process scientists/engineers to design, execute, document, and generate primary data packages for process development and technology transfer, applying experience in aseptic processing, equipment, automation, and unit operation characterization
• Support continuous improvements in the drug product development process through innovation and application of first principles in process engineering
• Support technology transfers of pipeline and commercial products and lifecycle management for various parenteral modalities
• Conduct make-a-batch exercises to determine facility fit and identify gaps
• Design and execute offline and on-site drug product characterization studies
• Evaluate product impact from manufacturing process, production scale, equipment, and raw material changes
• Author and/or own high-quality process technology transfer and other technical documents

Qualifications

• Basic Qualifications:
  • High school diploma / GED and 8 years of Operations or Process Development experience OR
  • Associate‚Äôs degree and 6 years of Operations or Process Development experience OR
  • Bachelor‚Äôs degree and 2 years of Operations or Process Development experience OR
  • Master‚Äôs degree
• Preferred Qualifications:
  • M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry, Biotechnology, or related discipline
  • Experience working with cross-functional groups to achieve results
  • Strong presentation skills and ability to draft technical documents
  • Familiarity with aseptic processing, drug product manufacturing, cGMPs, statistical design, DOE, and process characterization
  • Fill/finish process scale-up and technology transfer experience including gap analysis, root cause analysis, and risk assessment
  • Ability to leverage engineering principles with bench and pilot scale models for process characterization
  • Knowledge of formulation, filling, lyophilization, visual inspection, aseptic processing, and GMP/Device documentation for biotechnology products
  • Ability to learn and act on dynamic information quickly
  • Technology transfer experience across development phases and process scale-up
  • Experience in a matrix team environment across multiple functions

Skills

• Process development and technology transfer
• Aseptic processing and parenteral manufacturing
• First principles engineering, data analysis, and documentation
• Cross-functional collaboration and communication