Amgen Process Development Associate - Pivotal Drug Product 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 formulation and fill/finish process development, commercialization and lifecycle management. 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.

Responsibilities include:

•Participate in the planning, design, execution, and documentation of studies related to drug product formulation and fill/finish process development and characterization for 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.

Basic Qualifications

Bachelor’s degree or Bachelor’s degree complete by June 2019

OR

Associate degree and 4 years of scientific experience

OR

High school diploma / GED and 6 years of scientific experience

Preferred Qualifications

•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

We understand that to successfully sustain and grow as a global enterprise and deliver for patients — we must ensure a diverse and inclusive work environment.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.