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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.

Process Development Associate Scientist - Commercial Attribute Sciences

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be part of a team responsible for supporting commercial analytical methods and deliverables to ensure patient supply. Activities are varied including review/authoring/data verification of regulatory filings, method transfer/validation protocols/reports, method technical reports, and analytical raw data. Flexibility in handing’ multiple requests and prioritizing critical assignments will be key in delivering to commercial programs. Knowledge of technologies should include chromatography, spectroscopy, and compendia-based methods. A scientific background in Quality and/or Analytical Sciences will be appropriate.

Role Responsibilities:

• Responsibility for the technical compilation and drafting of method validation/transfer protocols and reports for analytical methods

• Perform sample analyses in support of process development studies for drug substance/drug product, for stability programs and investigations.

• Participate in method development/remediation, method qualification, method validation/transfer to quality control laboratories as well as from internal Amgen sites

• Testing responsibilities will include HPLC, ELISA, SDS- PAGE, capillary electrophoresis, and other general protein analytical methods

• Additional duties will include preparation of technical documentation performing in support of process development studies and participating in effective cross-functional collaborations with peers in Quality, Manufacturing and other Process Development groups.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The scientist professional we seek is a self-starter with these qualifications.

Basic Qualifications:

Master’s degree and 2 years of directly related experience

OR

Bachelor’s degree and 4 years of directly related experience

Preferred Qualifications:

• Experience in use of multiple analytical techniques

• Understanding of product quality attributes

• Expertise in analytical troubleshooting and decision-making.

• Experience in analytical method development, impurity identification and assessment of post-translational modifications.

• Solid understanding of cGMP and regulatory requirements

• Familiarity with Laboratory Information Management System (LIMS)

• Experience with CMOs or internal quality organizations (GMP, Controlled Document Systems)

• Strong technical writing skills

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 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.

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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.