Senior Engineer Process Development

Amgen is one of the world’s leading biotechnology companies. Amgen is a values-based company, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

Amgen is seeking a Senior Engineer Process Development in the Rhode Island location to apply fundamental scientific principles to cell culture processes in-order to execute technology transfer projects, resolve processing issues, and conduct technical assessment on process/product impact due to changes in equipment, scale, and raw materials.

Candidate will provide technical support and lead troubleshooting of clinical and commercial drug substance manufacturing. Design and execute experimentation to support process scale up, perform technical review of data, and author and review GMP documentation. The incumbent is responsible to keep current on the latest industrial, scientific and regulatory trends to assist in the review and authorship of relevant sections of global regulatory filings. The position provides opportunities to develop excellent leadership, teamwork, communication skills and to develop network influence by partnering with colleagues in Process Development, Manufacturing, as well as Quality and Information Systems. This role will immerse the candidate in all aspects of operations in a commercial bulk drug facility.

**Basic Qualifications:** * Doctorate degree or * Master’s degree AND 3 years of Engineering and/or Process Development experience or * Bachelor’s degree AND 5 years of Engineering and/or Process Development experience or * Associate’s degree AND 10 years of Engineering and/or Process Development experience or * High school diploma/GED AND 12 years of Engineering and/or Process Development experience **Preferred Qualifications:** * Four years of experience in drug substance process development, characterization and commercial process support * Possess advanced understanding of regulatory and cGMP requirements * Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements * Able to manage project resources and elevate relevant issues to project lead and line management * Excellent written and verbal communication * Able to build and maintain high-performing, cross-functional partnerships and to lead matrix teams to advance complex projects to completion * Demonstrated ability to work under minimal direction * Be able to multi-task and function in a dynamic environment