Engineer - Process Development
Amgen
11 days ago
On-site
Cambridge, MA
Operations
Engineer – Process Development
Responsibilities (What You Will Do)
- Support process development and technology transfer of drug substance synthetics processes across development and commercialization.
- Develop and optimize synthetic unit operations aligned for intended technology transfer and commercial support phases.
- Conduct experimental design and execution, data analysis, process risk analysis, process characterization, facility fit assessment, and in-plant support during production execution and equipment commissioning.
- Up to 20% domestic and international travel.
- Evaluate and execute experimental, modeling, and engineering techniques for process optimization, characterization, and scale-up.
- Author documents for process understanding, transfer, risk assessment, facility fit, and development/characterization.
- Troubleshoot equipment/systems and provide guidance.
- Monitor manufacturing performance indicators; recommend process improvements.
- Apply engineering principles and statistical analysis (including DoE) to solve processing issues.
- Communicate and collaborate with Manufacturing, Process Development, and Quality.
- Support regulatory and quality activities (non-conformance, process performance qualification, continued process verification).
Qualifications
Basic Qualifications
- Master’s degree
OR
- Bachelor’s degree + 2 years engineering/operations experience
OR
- Associate’s degree + 6 years engineering/operations experience
OR
- High school diploma/GED + 8 years engineering/operations experience
Preferred Qualifications
- Chemical engineering background
- 2+ years in Process Development/Process Engineering with synthetic manufacturing implementation/support
- Experience with scale-up and lab-to-pilot/manufacturing technology transfer
- Basic understanding of cGMP
- First-principles modeling experience and familiarity with multiple modeling platforms
- Analytical techniques/solid-state characterization (e.g., HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size)
- Statistical analysis/DoE background
- Plant operations and safety knowledge
- Project management, strong communication/presentation
Benefits (explicitly stated)
- Total Rewards Plan (health/welfare, financial plans, work/life balance, career development)
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending; bonus/incentives; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions
- Apply at careers.amgen.com.
Responsibilities (What You Will Do)
- Support process development and technology transfer of drug substance synthetics processes across development and commercialization.
- Develop and optimize synthetic unit operations aligned for intended technology transfer and commercial support phases.
- Conduct experimental design and execution, data analysis, process risk analysis, process characterization, facility fit assessment, and in-plant support during production execution and equipment commissioning.
- Up to 20% domestic and international travel.
- Evaluate and execute experimental, modeling, and engineering techniques for process optimization, characterization, and scale-up.
- Author documents for process understanding, transfer, risk assessment, facility fit, and development/characterization.
- Troubleshoot equipment/systems and provide guidance.
- Monitor manufacturing performance indicators; recommend process improvements.
- Apply engineering principles and statistical analysis (including DoE) to solve processing issues.
- Communicate and collaborate with Manufacturing, Process Development, and Quality.
- Support regulatory and quality activities (non-conformance, process performance qualification, continued process verification).
Qualifications
Basic Qualifications
- Master’s degree
OR
- Bachelor’s degree + 2 years engineering/operations experience
OR
- Associate’s degree + 6 years engineering/operations experience
OR
- High school diploma/GED + 8 years engineering/operations experience
Preferred Qualifications
- Chemical engineering background
- 2+ years in Process Development/Process Engineering with synthetic manufacturing implementation/support
- Experience with scale-up and lab-to-pilot/manufacturing technology transfer
- Basic understanding of cGMP
- First-principles modeling experience and familiarity with multiple modeling platforms
- Analytical techniques/solid-state characterization (e.g., HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size)
- Statistical analysis/DoE background
- Plant operations and safety knowledge
- Project management, strong communication/presentation
Benefits (explicitly stated)
- Total Rewards Plan (health/welfare, financial plans, work/life balance, career development)
- Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending; bonus/incentives; stock-based long-term incentives; time-off plans; flexible work models where possible.
Application Instructions
- Apply at careers.amgen.com.