Engineer - Pivotal and Commercial Synthetics
HOW MIGHT YOU DEFY IMAGINATION?
Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. 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. Become the professional you are meant to be in this meaningful role.Live
What you will do
Lets do this. Lets change the world. In this role you will be supporting process development and technology transfer of Amgens 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 Amgens 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 complete experimental, modeling and engineering techniques for process optimization, characterization, and scale up of synthetic active pharmaceutical ingredients in innovative facilities.
- Develop processes using continuous processing technologies, applying engineering fundamentals to define equipment and operational criteria.
- Initiate and complete technical transfer to 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 sophisticated 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.
What we expect of you
We are all different, yet we all use our outstanding contributions to serve patients. The engineering professional we seek will possess these qualifications.Basic Qualifications
Bachelors degree and 2 years of Engineering or Operations experienceOr
Associates degree and 6years of Engineering or Operations experienceOr
High School Diploma/GED and 8 years of Engineering or Operations experiencePreferred Qualifications
- Academic background in Chemical Engineering
- 3+ 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 applying 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 proficiency in a wide variety of techniques including HPLC, GC, MS, NMR, FTIR, LOD, TOC, FBRM, particle size determination, etc.
- Background in statistical analysis/DoE
- Solid understanding of standard plant operations and safety practices
- Excellent project management skills
- Strong verbal communication and presentation skills
Some of the vast rewards of working here
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
- Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
- A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Join UsIf 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.Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.