Engineer, Drug Product Process Engineering

Role Summary

Engineer, Drug Product Process Engineering. The role contributes to drug product process development, commercialization, and lifecycle management of Amgen’s parenteral product portfolio within the Drug Product Process Engineering team. Based in Thousand Oaks, CA, primarily first shift with possible on-call during second/third shifts.

Responsibilities

• Work with a team of process scientists/engineers to design, execute, document, and generate 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’s degree and 6 years of Operations or Process Development experience or
  • Bachelor’s degree and 2 years of Operations or Process Development experience or
  • Master’s degree
• Preferred Qualifications:
  • M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry or Biotechnology or related discipline
  • Experience working with cross-functional groups to achieve results
  • Proficiency in presentation skills and drafting 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 with gap analysis, root cause analysis, and risk assessment tools
  • Ability to apply engineering principles to bench and pilot scale models for process characterization
  • Knowledge of formulation, filling, lyophilization, visual inspection, aseptic processing and manufacturing of biotechnology products, GMP documentation, and regulatory filings
  • Ability to learn and act on dynamic information quickly
  • Technology transfer experience across development phases, fill-finish scale-up, and related tools
  • Experience in a matrix team environment coordinating with multiple functions

Skills

• Process development and technology transfer
• Aseptic processing and parenteral manufacturing
• First-principles process engineering
• Documentation and data package generation
• Cross-functional collaboration and matrix teamwork
• Analytical and problem-solving skills
• Technical writing and presentation proficiency

Education

• As listed under Qualifications – Preferred: M.S. in Chemical/Biomedical Engineering, Pharmaceutical Sciences, Chemistry/Biochemistry, Biotechnology or related discipline

Additional Requirements

• Occasional on-call responsibilities for second/third shifts may be required
• Travel not specified; role primarily based in Thousand Oaks, CA