Career Category

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. In this vital role you will contribute to developing, validating and implementing robust bioanalytical methods for the detection of biological activity of a drug and characterization of any anti-drug neutralizing antibodies that may be formed to our administered therapeutic proteins in nonclinical and clinical studies. This assessment is vital for drug development of therapeutic protein candidates.

Amgen is seeking a Scientist in the immunogenicity bioanalytical area to work at our Thousand Oaks, CA location. The department of Translational Safety & Bioanalytical Sciences (TS&BA) within Amgen is dedicated to the discovery and development of novel effective, safe medicines. TS&BA Scientists work closely in partnership with other teams, such as protein therapeutics, medicinal chemistry, pharmacology, toxicology, pharmaceutical sciences and clinical pharmacology and regulatory to design promising clinical therapeutic candidates, conduct preclinical development studies, support clinical evaluation and contribute to regulatory submissions.

Primary Responsibilities

• Develop and establish high sensitivity and specificity, cell-based assays for measurement of drug activity in biological matrices

• Adapt serum-based biological activity assays for the detection of anti-drug neutralizing antibodies in biological matrices

• Engineer novel cell lines that provide improved assay systems for detection of drug activity and neutralizing antibody detection in biological matrices

• Validate cell-based assays for the detection of anti-drug neutralizing antibodies

• Transfer abovementioned cell-based assays to external service providers

• Handle the method lifecycle by working with external service providers, performing troubleshooting, data review and engaging in continuous improvement efforts.

• Conduct sample analysis, maintain adherence to timelines, write bioanalytical study reports and review data for technical content and regulatory compliance.

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 innovative and motivated with these qualifications.

Basic Qualifications:

• Doctorate degree OR

• Master’s degree and 4 years of pharmaceutical-biotechnology and/or CRO industry, and/or Scientific experience OR

• Bachelor’s degree and 6 years of pharmaceutical-biotechnology and/or CRO industry and/or Scientific experience

Preferred Qualifications:

• 2+ years’ experience with in vitro mammalian cell culture

• 2+ years of relevant laboratory GxP experience.

• Analytical skills in applying a broad range of technologies used for cell-based assays (mammalian cell lines, reporter cell lines, etc.)

• Experience in molecular biology techniques

• Experience in engineering novel cell lines

• Experience in any of the following areas: immunology, immunochemistry, biochemistry, cell biology or equivalent.

• Solid understanding of the regulatory (GxP) requirements for bioanalysis in drug development and possess critical thinking skills with an ability to integrate data and information to solve sophisticated problems to advance drug discovery and development programs.

• Experience communicating complex ideas to audiences with varying degrees of knowledge.

• Proven ability to drive scientific excellence and innovation.

• Demonstrated experience of contributing as lead author on external peer review publications.

• Ability to work in a team environment with excellent verbal and written communication skills.

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 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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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 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 and Puerto Rico 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