Senior Engineer - Process Development

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

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. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. 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 - Process Development

What you will do

Let’s do this. Let’s change the world. In this vital role you will be accountable to advance industry leading solutions for the design, development, and deployment of synthetic and hybrid drug substance manufacturing processes across all phases of development through commercialization. The qualified candidate will be proficient in chemical engineering fundamentals, process development & characterization, and process safety & scale-up for synthetic processes using both batch and continuous technologies. The Senior Engineer will provide technical leadership for reaction engineering, unit operation assessment, and technology development &

implementation.

The Senior Engineer will partner with or lead a multi-functional group of engineers and scientists through the process development cycle at Amgen to ensure our process requirements and knowledge are suitable for the intended phase of technology transfer, which will include process introduction, clinical

manufacturing, validation and commercial manufacturing. While working with our manufacturing teams to determine if equipment and manufacturing operations meet process requirements and will collaborate with the production site(s) to introduce new equipment and capabilities.

The Senior Engineer will be responsible for authoring technical reports, leading risk assessments, and contributing to regulatory documents through all phases of technology transfer and commercialization.

Technical and lab-based execution of bench and kilogram-scale experimentation and process modeling & simulation to design and optimize robust synthetic and hybrid processes.

• Critical evaluation of novel chemical processes for the identification of process improvement opportunities and requirements vital to ensure safe and successful scale-up and tech transfer.
• Design, optimize, and deploy process models for reaction kinetics, mass transfer, separations, distillations, isolations, drying, and relevant hydrodynamic operations.
• Model and analyze the economic value and environmental impact of process synthetic processes and manufacturing concepts.
• Initiate and complete standard practices for technology transfer of synthetic processes which include drafting process transfer documents, process fit assessments, manufacturing support, risk analysis and process documentation.
• Represent organization within a multi-functional team to ensure deliverables are aligned with tech transfer timeline, such that key achievements are established and achieved.
• Apply standard and sophisticated engineering techniques and procedures to provide solutions to a variety of technical chemical and process issues that will be encountered during process development, tech transfer and scale-up.
• Routinely monitor manufacturing processes for performance indicators and operations. Lead problem resolution and provide troubleshooting guidance.
• Apply engineering principles and statistical analysis, including design of experiments, in order to critically evaluate chemical processes for identification of process improvements and requirements vital for scale up and tech transfer.
• Author, review and/or approve of process documentation needed for process validation and commercialization activities.
• Contribute to key regulatory and quality activities such as NDAs, non-conformances, process performance qualification and continued process verification.
• Provide on-the-floor support to ensure successful scale-up and facilitate rapid problem solving and decision-making.
• Lead or represent department as domain expert for process risk analysis.
• Work closely with process development chemists, formulation scientists, and analytical chemists to generate and interpret data to provide improved unde