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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. 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. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Process Development Scientist

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you 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. Responsibilities include:

• Integrate and successfully utilize platform and prior product knowledge to advance Amgen practices and ensure success from FIH study through to marketing application.
• Define analytical control strategies and implement methodologies for development of pivotal phase clinical programs.
• Collaborate closely with drug substance and drug product process development colleagues.
• Manage 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 partner with these qualifications.

Basic Qualifications:

• Doctorate degree or Doctorate degree completed in 2021 OR Master’s degree and 4 years of scientific experience OR Bachelor’s degree and 6 years of scientific experience

Preferred Qualifications:

• PhD in Analytical Chemistry, Organic Chemistry, Materials Science, Biochemistry, Biochemical or Chemical Engineering
• Experience in the pharmaceutical or biotech industry in process and product development and drug substance and drug product analytical method development is a plus.
• Strong understanding of small molecule analysis, structure elucidation and solid-state characterization guided and informed by knowledge of organic chemistry.
• Experience in a wide variety of analytical techniques including chromatography, mass spectrometry, UV, NMR, FTIR, solid state characterization, etc.
• 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.
• Solid 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 deliverables against timelines
• Strong communication skills and ability to provide cross-functional leadership and guidance to CMC and non-clinical teams, e.g. informing 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

What you can expect of us

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.

• Vast opportunities to learn and move up and across our global organization
• 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

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

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.