Senior Engineer - Drug Substance Technology & Engineering

Operations

• 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 investigate processing issues, identify process risks, and evaluate process improvement opportunities.
• Lead or support deviations, investigations, root‑cause analyses, CAPAs, change controls, and risk assessments. Develop timely controls and effective actions that reduce recurrence.
• Evaluate, select, and apply appropriate engineering techniques and procedures to resolve technical process, equipment, and manufacturing issues.
• Partner with Process Development to ensure processes are robust, scalable, and designed to consistently deliver required product quality attributes and enable manufacturing success.
• Collaborate with Manufacturing, Quality, Process Development, Validation, Regulatory, Supply Chain, Facilities and Engineering, and network drug substance teams to deliver technical solutions and achieve plant and project objectives.
• Author, review, and maintain technical documentation, including protocols, reports, process…