Senior Engineer - Drug Substance Technology & Engineering

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity‑related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award‑winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Senior Engineer

Let’s do this. Let’s change the world. In this vital role you will provide downstream purification manufacturing support supporting a diverse portfolio of both clinical and commercial biologics drug substance products. You will provide engineering oversight and play a key role in early phase technology transfer and the manufacturing execution, process optimization, and strategic improvement initiatives across all phases of development and the commercialization lifecycle.

The role combines hands‑on technical leadership with direct people management. You will work with a cross functional group of engineers and scientists through the process development cycle at Amgen and contract site(s) to ensure successful technology transfer, manufacturing, and regulatory support. You will also use your engineering experience in the oversight and operations of production facilities; including process execution, equipment utilization, and optimization.

Additionally, you will directly manage and develop other downstream process engineers, and guide manufacturing execution, on‑floor escalation support, process monitoring, complex investigations, and process improvement across downstream purification operations.

You will build productive partnerships with Manufacturing, Quality, Process Development, Validation, Regulatory, Facilities and Engineering, Supply Chain, and network teams in support of a highly dynamic manufacturing facility. Limited domestic and international travel may be necessary at times.

The ideal candidate should be well versed in tech transfer, process development, scale up, modeling, optimization, characterization, regulatory support and GMP commercial production.

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 execute technology transfer and manufacturing support activities, including process transfer documentation, process and facility‑fit assessments, risk analyses, manufacturing readiness activities, and process documentation.

Represent DSTE on cross‑functional teams to ensure deliverables supporting technology transfer, manufacturing execution, investigations, and process improvements are completed on schedule.

Provide on‑floor manufacturing support and technical escalation support to enable safe, compliant, and reliable manufacturing execution.

Routinely monitor process and operational performance using relevant manufacturing, process, and product data. Lead problem resolution and provide troubleshooting guidance for process performance issues.

Apply engineering principles, statistical analysis, and design of experiments, as appropriate, to…