Job was saved successfully.
Job was removed from Saved Jobs.

Job Details


Amgen

Commercial Attribute Science - Scientist (R-145248)

Pharmaceuticals

All

Yearly

No

Cambridge, Massachusetts, United States

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.

Commercial Attribute Science - Scientist

Live

What you will do

Let’s do this! Let’s change the world! In this vital Scientist - Analytical Chemist role, you will join our Commercial Attribute Sciences team.

Our Commercial Attribute Sciences department is responsible for commercial analytical support, including method validation, method transfer, method remediation, method investigation support, process and product development manufacturing support.

The Scientist will work closely with a team of analytical chemists, organic chemists and formulators responsible for the technical aspects of developing the analytical tools to gain understanding of key attributes for synthetic manufacturing processes and synthetic products. The Scientist will integrate and effectively apply platform and prior product knowledge to advance Amgen practices and ensure success of the commercial synthetic portfolio.

Key Responsibilities:
  • Define analytical control strategies and implement methodologies for commercial programs.
  • Collaborate closely with drug substance and drug product process development colleagues.
  • Facilitate activities at contract manufacturing and testing sites.
  • May lead and develop a small group of scientists.
Win

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 and motivated team-player with these qualifications.

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 4 years of scientific experience in analytical sciences

Or

Bachelor’s degree and 6 years of scientific experience in analytical sciences

Preferred Qualifications:
  • PhD in Analytical Chemistry, Materials Science
  • 2+ year’s post-PhD experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development
  • Strong understanding of small molecule analysis
  • Experience in a wide variety of analytical techniques, including mass spectrometry, UV, NMR, FTIR, chromatography, particle size determination, crystal characterization, etc.
  • Experience developing and implementing methods for in-process testing, release and stability testing
  • Experience in analytical testing requirements for immediate release and controlled release oral solid dosage drug products
  • Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
  • Proven understanding of GLP and GMP requirements and their application in a phase appropriate manner
  • Experience in technical transfer for non-GMP and GMP production and testing to external contract organizations, able to manage results against timelines
  • Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. advising and defending the Quality Target Product Profile
  • Works well in cross-functional teams, and across various geographic locations in different time zones
  • Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents
Thrive

Some of the vast rewards of working here

As we work to develop treatments that take care of others, we also 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
Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

[Register to View]

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.

We will ensure that individuals with disabilities are provided 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 accommodation.

Amgen requires all staff in the United States, Puerto Rico and Canada 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.