Process Development Engineer – Drug Product

About the role

Join Amgen’s process development team to support senior staff in developing and characterizing drug product technologies and manufacturing capabilities. You will execute lab‑scale and production‑scale experiments, generate technical data packages, and help transfer multiple Amgen products to internal manufacturing sites.

Key responsibilities

• Apply engineering and scientific principles to resolve issues and evaluate process improvements.
• Design and execute experiments for new capabilities such as filling, lyophilization, and analytical technologies.
• Support technology transfer leads during make‑a‑batch exercises, documentation, and change control assessments.
• Develop and automate technology transfer tools and routine activities.
• Communicate results of characterization studies and technology transfer initiatives to cross‑functional teams.
• Author, review, and verify technical documents, protocols, assessments, reports, and SOP drafts.
• Conduct statistical data analysis using Minitab, JMP, or similar tools.
• Develop digital tools and models leveraging data analytics, programming, and AI.

Required profile

• B.S. in engineering or biotechnology (or M.S.) with relevant experience.
• Familiarity with cGMP and drug product/substance manufacturing or process development.
• Hands‑on experience with various drug product technologies.
• Strong critical‑thinking, problem‑solving, and independent research skills.
• Ability to learn new techniques, maintain accurate records, and follow company policies.
• Excellent project‑management capabilities.

Required skills

• Minitab
• JMP
• Statistical analysis
• Data analytics
• Programming
• Artificial intelligence (AI)