Senior Engineer - Drug Substance Technology & Engineering

About the role

Amgen is hiring a Senior Engineer for its Drug Substance Technology & Engineering team. The role provides downstream purification manufacturing support for a portfolio of clinical and commercial biologics drug substances, with engineering oversight and a key part in early-phase technology transfer. It combines hands-on technical leadership with direct people management.

Key responsibilities

• Lead technical support for cGMP clinical and commercial downstream purification processes, including harvest and clarification, chromatography, viral filtration, UF/DF and sterile filtration.
• Initiate and run technology transfer and manufacturing support, including process transfer documentation, fit assessments, risk analyses and manufacturing readiness.
• Represent DSTE on cross-functional teams and provide on-floor manufacturing and technical escalation support.
• Monitor process and operational performance, lead problem resolution and provide troubleshooting guidance.
• Apply engineering principles, statistical analysis and design of experiments to investigate issues and improve processes.
• Lead or support deviations, investigations, root-cause analyses, CAPAs, change controls and risk assessments.
• Partner with Process Development to ensure processes are robust and scalable, and collaborate with Manufacturing, Quality, Validation, Regulatory, Supply Chain and other teams.
• Author, review and maintain technical documentation such as protocols, SOPs, batch record support documents and engineering assessments.
• Contribute to process validation, PPQ, continued process verification, regulatory filings and inspections.
• Mentor less experienced engineers and coach staff through complex technical decisions.

Required profile

• Doctorate, or Master's degree with 2 years of engineering experience, or Bachelor's degree with 4 years, or Associate's degree with 8 years, or high school diploma with 10 years of engineering experience.
• Preferred: 5+ years in downstream purification, and 2+ years directly managing people or leading teams, projects and programs.
• Ability to lead cross-functional teams and influence decisions across competing priorities.

Required skills

• Strong expertise in downstream purification and commercial biologics manufacturing.
• Experience with process development, scale-up, technology transfer, process validation, PPQ and manufacturing execution.
• Understanding of cGMP, regulatory, safety and quality requirements, including regulatory filings and inspections.
• Use of engineering principles, statistical analysis and process data to troubleshoot and improve processes.