Senior Engineer - Process Development at Amgen

HOW MIGHT YOU DEFY IMAGINATION?

Youve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Senior Engineer - Process Development

Live

What you will do

Lets do this. Lets 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 understanding and guidance for synthesis and unit operations.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Senior Engineer professional we seek is a dynamic teammate with these qualifications.

Basic Qualifications:

• High school diploma / GED and 10 years of Engineering or Operations experience
• Associates degree and 8 years of Engineering or Operations experience
• Bachelors degree and 4 years of Engineering or Operations experience
• Masters degree and 2 years of Engineering or Operations experience
• Doctorate degree

Preferred Qualifications:

• 5+ years of engineering experience getting results related to synthetic process development and chemical manufacturing.
• Experience in developing and implementing experimental plans to evaluate and develop processes to achieve optimum cost, robustness, and productivity.
• Experience related to technology transfer, scale-up and manufacturing of synthetic molecules in a regulated environment. This includes technical support for non-conformance investigations and other commercial support activities.
• Experience authoring regulatory documents for commercialization of drug substance processes: CMC Module 3, RTQs, and annual reports.
• Experience building and applying first-principle models (e.g., reaction kinetics, mass transfer, separations, distillations, isolations, drying, and hydrodynamics) with proficiency across several modeling platforms.
• Knowledge of analytical techniques and solid-state characterization with proficiency in a wide variety of methods including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.
• Experience using data science and/or sophisticated statistical analysis to address processing issues and evaluate opportunities for process improvements.
• Proficient understanding of regulatory and cGMP requirements
• Command of lab and plant operations and associated safety practices
• Strong communication and presentation skills

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates professional and personal growth and well-being.

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Apply now for a career that defies imagination

Objects in your future are closer than they appear. Join us.

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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