Engineer - Process Development

Responsibilities

• Support process development and technology transfer of drug substance synthetics processes across all development phases
• Evaluate, select, and execute experimental, modeling, and engineering techniques for process optimization and scale-up
• Perform technical tasks in lab, kilo/pilot plant, and manufacturing environments
• Author technical documentation for process understanding, risk assessment, and facility fit
• Apply engineering principles and statistical analysis, including Design of Experiments (DoE), to solve processing issues
• Monitor manufacturing processes for performance indicators and provide troubleshooting guidance
• Collaborate with Manufacturing, Process Development, and Quality departments to ensure regulatory compliance

Requirements

• Master's degree in Engineering, or Bachelor's degree with 2 years of Engineering or Operations experience
• Background in Chemical Engineering
• Experience in process scale-up and technology transfer from laboratory to manufacturing scale
• Knowledge of cGMP requirements and standard plant safety practices
• Proficiency in statistical analysis and Design of Experiments (DoE)
• Experience with analytical techniques such as HPLC, GC, MS, and NMR

Preferred Qualifications

• 2+ years of experience in a Process Development or Process Engineering environment
• Experience building and utilizing first principle models (reaction kinetics, mass transfer, etc.)
• Knowledge of solid-state characterization and various analytical techniques (FTIR, LOD, TOC, FBRM)
• Strong project management and verbal communication skills

Benefits

• Comprehensive health and welfare plans, including medical, dental, and vision coverage
• Retirement and Savings Plan with company contributions
• Discretionary annual bonus program
• Stock-based long-term incentives
• Award-winning time-off plans

About the Company

Amgen is a leading biotechnology company dedicated to discovering, developing, and manufacturing innovative human therapeutics. Since 1980, Amgen has focused on serving patients living with serious illnesses in therapeutic areas such as Oncology, Inflammation, General Medicine, and Rare Disease.