Principal Engineer - Synthetic Process Development

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Principal Engineer - Synthetic Process Development

What you will do

Lets do this. Lets change the world. In this vital role is accountable to drive lab-based technical solutions and provide overall guidance and leadership for the development, characterization, and technology transfer of synthetic and hybrid drug substance manufacturing processes across all phases of development through commercialization and lifecycle management. To achieve this goal, the Principal Engineer will partner multi-functionally with Amgens chemistry, analytical, drug product, quality, safety, and operations teams to ensure successful transfer, implementation, and validation of Amgens drug substance processes at internal and external clinical and commercial manufacturing facilities.

• Contributes to and leads program deliverables for the advancement of our synthetic & hybrid portfolio through all stages of commercial Process Development and lifecycle management
• Accountable for establishing and implementing engineering standards for commercial Process Development and process characterization
• Drives excellence in execution for technical transfers of innovative DS processes
• Adheres to and drives all standards for safety, quality, and compliance
• Enhances performance through the continuous advance of technical capabilities and technical and strategic competencies within the engineering team
• Lab-based contributions and general leadership of our drug substance processes using a foundational chemical engineering abilities and practical knowledge of relevant unit operations.
• Process Development: supporting the development of chemical processes and positioning drug substance processes for commercialization success by designing and performing experimental plans; leading, implementing and deploying process-analytical tools (PAT) to enable process understanding and design; process simulation using an array of process modeling and engineering tools; and process characterization.
• Expert Analysis: including process and technology review analysis and improvement identification; assessment of applicable new technologies and techniques.
• Contribute to increasing the effectiveness and efficiency of the department by contributing towards improvements of guidelines, procedures, practices, standards and multi-functional business interfaces and processes.
• Contributes effectively as an individual and also routinely leads process engineering and drug substance development teams
• Identifies resource needs and establishes priority for projected activities
• Facilitates cohesiveness and builds team spirit as we work toward a common goal to develop industry-leading medicines that serve patients
• Communicates effectively with others, demonstrating compassion and the principles of people-centered leadership

What we expect of you

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

Basic Qualifications:

• High school diploma / GED and 12 years of proven experience OR
• Associates degree and 10 years of proven experience OR
• Bachelors degree and 6 years of proven experience OR
• Masters degree and 4 years of proven experience OR
• Doctorate degree and 2 years of proven experience

Preferred Qualifications:

• 8+ years of relevant chemical engineering experience driving individual and group deliverables related to Synthetic Process Development and chemical manufacturing in pharmaceutical development.
• Experience in developing and implementing experimental plans to evaluate and develop processes to achieve optimum cost, adaptability, safety, sustainability, and efficiency.
• Experience related to technology transfer, scale-up and manufacturing of synthetic molecules and hybrid modalities in a regulated environment. This includes technical support for non-conformance investigations and other commercial support activities.
• 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.
• Proficiency in lab-based implementation of and data interpretation for wide variety of analytical methods, process analytical tools, and solid-state characterization methods including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.
• Evaluate early- and late-stage chemical processes to establish and implement lab-based pre-requisites to enable of bench/kilo laboratory experiments to ensure successful scale-up to manufacturing scales.
• Apply chemical engineering fundamentals 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, including leading on the floor support and rapid problem solving and decision making.
• Apply engineering principles and statistical analysis, including design of experiments, evaluate chemical processes for potential process improvements to enable successful scale-up and transfer to manufacturing sites.
• Lead and handle authoring of user documentation required for process characterization design plans, failure-mode risk assessments for science-based determination of parameter and test criticality, engineering scale-up evaluations, process validation preparedness across all stages of development.
• Experience authoring regulatory documents for commercialization of drug substance processes: CMC Module 3, RTQs, and annual reports.
• Practical experience using data science and/or advanced statistical analysis to tackle 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
• Excellent communication and presentation skills and motivation to lead teams of engineers and chemists through different stages of chemical Process Development in lab-based execution
• Domestic and International Travel: up to 20%

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 driven and comprehensive Total Rewards Plans that are aligned with local industry standards.

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. 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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