Amgen Process Development Associate in Cambridge, Massachusetts
Based in Cambridge, MA, the role of Associate in Pivotal Drug Product Technologies will be to provide support for Amgen’s biologics drug product and process design, commercialization and lifecycle management. The Associate will work closely with a team of engineers and scientists responsible for the technical aspects of Amgen’s drug product and process development. In addition to performing process characterization and formulation studies, this role will also focus on data analytics, statistical modeling, and data visualization technologies. The Associate will integrate and utilize platform capabilities, prior product knowledge, and data analytics/visualization to advance Amgen products and ensure success through the commercialization process.
Participate in the planning, design, execution, and documentation of studies related to drug product design, formulation development, and process development in support of commercialization and life cycle management of biologics.
Perform analytical characterization supporting attribute and stability assessments using chromatography and biophysical characterization tools.
Actively utilize advanced IS systems to improve drug product design through faster data availability, leveraging historical information, analyzing large data sets, and statistical analysis.
Create visualizations to enable business application of data analysis.
Explore and evaluate new digital tools and techniques to improve the team’s developmental and operational capabilities
As needed, provide support to clinical and commercial fill/finish manufacturing operations through process capability analysis, troubleshooting, root cause analysis, and product impact assessments for non-conformance investigations and process changes/improvements.
Deliver progress reports and presentations to ensure management awareness and engagement of the status, progress, and future program and functional needs.
Associate degree and 4 years of scientific experience
High school diploma / GED and 6 years of scientific experience
Bachelor’s degree in Chemical Engineering, Biomedical Engineering, Chemistry, Biochemistry, or other relevant sciences
Demonstrated ability to identify, develop and implement solutions to practical problems through application of fundamental scientific and engineering principles, preferably in a process development environment
Basic understanding of physical/chemical stability of proteins and how process related stress impacts molecule attributes and product quality
Proficiency in at least one statistical software package (such as SIMCA or JMP)
Experience with coding/scripting for automated data analysis and modeling to enable better access and standardization across the function
Strong problem solving and effective cross-functional communication skills.
Demonstrated success working with diverse team members in a dynamic, cross-functional environment
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.
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.