Process Development Associate
HOW MIGHT YOU DEFY IMAGINATION?
Youveearned your degree. How will you use that achievement to reach your goals? Do more with the knowledgeyouveworked 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.
What you will do
Letsdo this.Letschange the world. In this vital role you will be the liaison to our customers by providing clinical knowledge of our products to medical professionals.
Amgen's medicines treat serious illnesses and our research address diseases with a limited number of treatment options. With a robust and differentiated pipeline, Amgen remains committed to advancing science to dramatically improve people's lives.
Based in Cambridge, MA, the role of Associate in Pivotal Drug Product Technologies will be to provide support for Amgens 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 Amgens 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 teams 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.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients.
Associates degree and 4 years of Scientific experience
High school diploma / GED Scientific experience
- Bachelors 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
Some of the vast rewards of workinghere
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 careerjourney
A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table andact
Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) onGlassdoor
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Amgen is a Fortune 150 company operating in nearly 100 countries around the world, we invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of ourpatients
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing,manufacturingand 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.
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.