Career Category

Job Description

Job Description

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.

Live

What you will do

Let’s do this! Let’s change the world!  There an exciting career opportunity to join the Commercial Attribute Sciences team at the Amgen Rhode Island site.  In this role as a Senior Associate, you will:

·Execute routine and characterization testing using multiple analytical methods and technologies to support commercial and NPI programs.

·Interact and collaborate with multiple functional areas in matrix environment, both at site and network levels.

·Interpret results, author and review technical reports and assessments.

·Support technology and method lifecycle management, including method transfers, qualifications, improvements, trending and remediations

·Support process improvements, including analytical comparability, small-scale model support

·Support site Forensics team in commercial manufacturing and PD investigations.

Basic Qualifications:

Master’s degree

OR

Bachelor’s degree and 2 years of Scientific or Operations experience

Preferred Qualifications:

• 3+ years of scientific experience providing and driving analytical deliverables for biopharmaceutical processes and product development
• Expert knowledge of analytical methods/technologies used in biologics for both routine and characterization testing using one or more of the following: HPLC, CE, ELISA, and/or other techniques
• Understanding of product quality attributes for biologics, their control strategies, quality attribute assessments, and Quality Target Product Profile throughout the lifecycle of a product
• Experience working in a matrix environment
• Experience in data analysis, statistical analysis, method qualifications/transfers
• Experience in applying troubleshooting and investigation methodologies for problem solving
• Familiarity with biopharmaceutical manufacturing processes
• Familiarity with forensics analysis
• Familiarity with regulatory expectations related to analytical control strategies, familiar with applicable US and worldwide regulatory requirements
• Strong technical writing and verbal communication skills