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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.

Senior Associate Scientist

We are currently seeking an enthusiastic, highly motivated, and team-oriented individual for the position of Sr. Associate Scientist position in our Pre-Pivotal Attribute Sciences Group, Amgen, based in Thousand Oaks, CA. This group supports analytical development for Amgen’s Early-Stage biological programs. The Sr. Associate Scientist will support product stability studies in the Pre-Pivotal stage of development with the focus on understanding the stability of FIH clinical candidates by assessing the quality attributes. The successful candidate is expected to have extensive hands-on experience of standard protein characterization assays and knowledge of developing and applying these methods to characterize in-process, stability, and forced degradation samples.

Key responsibilities:

• Work in a collaborative environment including partner with different functional areas to support product and process characterization studies, data analysis and investigation.

• Work closely with Attribute Sciences Team Leads (ASTLs) to develop stability study protocols and establish strategies for stability studies for new product.

• Monitor stability studies and status of laboratory test results and communicate with ASTLs about the progress of stability programs according to the established protocols.

• Analyze large data sets to identify trend, interpret results, draw conclusions, and author stability technical reports with good understanding of product stability.

• Escalate unusual observations, deviations, or any incidence of non-compliance with established protocols or procedures.

• Update the stability reports after each time point pull and maintain the reports for the duration of the stability study lifecycle in timely manner

• Other duties include maintenance of electronic notebook records of experimental data, participation in authoring of technical protocols and reports, and presentation of results in internal meetings

Basic Qualifications

Master’s degree & 3 years of scientific experience OR Bachelor’s degree & 5 years of scientific experience

Preferred Qualifications

• MS in Biochemistry, Biophysics or closely related field

• 4+ years of experience in industrial analytical laboratories supporting characterization of protein therapeutics

• Advanced technical expertise in analytical methodologies used to characterize protein therapeutics including CE, SEC, IEX, RP and HILIC, with good understanding both theoretical and practical aspects of stability-indicating assay, e.g., design, performance, results, etc.

• Working knowledge of data processing and analysis tools in Excel and other statistical software

• Hands on experience with method qualifications and transfers

• Demonstrated knowledge of cGXP regulations and guidance

• Ability to work in a matrix team environment and collaborate effectively

• Ability to independently handle and prioritize multiple tasks

• Good written and verbal communication skills

• Familiarity with Laboratory Information Management System (LIMS) and electronic lab notebook (ELN)

Thrive

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 improve 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.

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