Engineer - Pivotal and Commercial Synthetics
Would you like to work with a diverse, highly motivated team of process science professionals to positively impact patients' lives? We are seeking an Engineer in the Pivotal and Commercial Synthetic's department at Amgen.
The Engineer will be responsible for supporting process development and technology transfer of Amgen's drug substance synthetics processes across all phases of development and commercialization. Chemical engineering fundamentals will be applied to generate process understanding and implement scalable drug substance processes that deliver Amgen's pipeline.
The Engineer will partner with a multi-functional group of engineers and scientists through the process development cycle at Amgen develop and optimize synthetic unit operations aligned for the intended phase of technology transfer and commercial support. This includes experimental design and execution, data analysis, process risk analysis, process characterization, facility fit assessment, and in-plant support of production operations during process execution and equipment commissioning.
Domestic and International Travel: up to 20%
Specific responsibilities include but are not limited to:
- Under limited supervision will evaluate, select and execute standard experimental, modeling and engineering techniques for process optimization, characterization, and scale up of synthetic active pharmaceutical ingredients in state-of-the-art facilities.
- Initiate and complete technical tasks in lab, kilo/pilot plant, and manufacturing environments.
- Author documents for process understanding, transfer, risk assessment, facility fit, and development/characterization.
- Function as a technical expert to equipment or systems regarding troubleshooting operations.
- Frequently become actively involved in daily production or development operations when required to meet schedules or to resolve complex problems.
- Routinely monitor manufacturing processes for performance indicators and operations. Suggest problem resolution, provide troubleshooting guidance and recommend process improvements.
- Apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements.
- Communicate and collaborate with Manufacturing, Process Development, and Quality departments.
- Contribute to key regulatory and quality activities such as non-conformances, process performance qualification and continued process verification.
Bachelor's degree and 2 years of Engineering or Operations experience
Associate's degree and 6 years of Engineering or Operations experience
High school diploma / GED and 8 years of Engineering or Operations experience
- Academic background in Chemical Engineering
- 2+ years of experience in a Process Development/Process Engineering environment, with specific experience in the implementation and support of synthetic manufacturing processes
- Experience in process scale-up and technology transfer from laboratory to pilot and/or manufacturing scale
- Basic understanding of cGMP requirements
- Experience building and utilizing first principle models (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 fluency in a wide variety of techniques including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.
- Background in statistical analysis/DoE
- Working knowledge of standard plant operations and safety practices
- Excellent project management skills
- Strong verbal communication and presentation skills
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.