Amgen Scientist – Attribute Sciences Team Lead - Commercial Attribute Sciences in Cambridge, Massachusetts
HOW MIGHT YOU DEFY IMAGINATION?
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Scientist – Attribute Sciences Team Lead - Commercial Attribute Sciences
What you will do
Let’s do this. Let’s change the world. In this vital role you will provide scientific and technical expertise to support the commercialization of Amgen’s pipeline. This group identifies and coordinates the achievement of product attributes toward quality target product profiles, develops and applies fit-for-purpose analytical methodologies.
The role is in a newly established function dedicated to enhancing attribute understanding and method performance for biotechnology products. Responsibilities will include the development of computational and statistical data tools for monitoring analytical method performance and attributes. The position offers an opportunity to make an impact through deployment of data driven approaches on a dynamic and varied product portfolio in a highly cross-functional, phase independent and collaborative environment.
Responsible for analytical leadership of a commercial program(s) including method lifecycle management, method transfer, validation and remediation.
Represent Attribute Sciences as a core member of Product Delivery Team(s).
Provide analytical subject matter expert technical support to commercial testing, stability programs and manufacturing operations.
Interact and collaborate with global cross-functional team that includes DS and DP operations, Quality, Regulatory CMC and Supply Chain.
As an Attribute Sciences Team Lead (ASTL), will integrate and successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success of the commercial portfolio.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The scientific professional we seek is a collaborative individual with these qualifications.
Master’s degree and 4 years of Scientific or Operations experience
Bachelor’s degree and 6 years of Scientific or Operations experience
Scientist with 5+ years of experience in providing and driving analytical deliverables for biopharmaceutical processes and product development.
Deep understanding of product quality attributes control strategies, quality attribute assessments, and Quality Target Product Profile throughout the lifecycle of a product.
Expert knowledge of analytical methods/technologies used in biologics for both routine and characterization testing using HPLC, CE, LC/MS, ELISA, and/or other techniques.
Experience with developing, implementing and commercializing methods for in-process testing, process characterization, release and stability testing.
Possess strong understanding of regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements.
Understanding of biopharmaceutical manufacturing processes.
Demonstrated experience working in matrix environment.
Experience in technical transfer for GMP production and testing to external contract organizations, able to manage deliverables against timelines.
Experience in data analysis, statistical analysis, setting acceptance criteria, comparability studies, and process/method transfers.
Experience in applying troubleshooting and investigation methodologies.
Strong technical writing, 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 Plan—comprising health, finance and wealth, work/life balance, and career benefits—with 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.
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.