Senior Scientist- Immunogenicity Bioanalytical

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.

Senior Scientist- Immunogenicity BioanalyticalLive

What you will do

Lets do this. Lets change the world. In this vital role you will contribute to drug development by developing and validating methods for the detection and characterization of any anti-drug antibodies (ADAs) that may be formed to administered therapeutic proteins in nonclinical and clinical studies. This assessment is vital for the drug development of therapeutic protein candidates and for assessing their immunogenicity.

Amgen is seeking a Senior 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, plate-based immunoassays for the detection of anti-drug antibodies in biological matrices

• Utilize a diverse set of instruments and technologies, such as (but not limited to) electrochemiluminescence-based detection, ELISA, Surface Plasmon Resonance, HPLC, etc. (detection platforms)

• Validate ADA assays in accordance with GLP and GCP regulatory guidelines

• Transfer abovementioned ADA assays to external service providers

• Manage 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.

• Participate in research efforts directed at improving process workflow efficiencies and for expanding the range of immunogenicity ADA assays and applications

• Participate in expanding the range of immunogenicity ADA assay formats and applications from conceptualization to experimental design through implementation

• Additional responsibilities will include mentoring or supervising

• Participate in national and international scientific meetings

• Author SOPs, method-related technical documents and bioanalytical study reports for regulatory submission and/or generation of publications and patents

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is a Senior Scientist with these qualifications.

Basic Qualifications

Doctorate degree and 2 years scientific experience

OR

Masters degree and 5 years scientific experience

OR

Bachelors degree and 7 years scientific experience

Preferred Qualifications

• 2+ years of relevant laboratory GxP experience.

• Analytical skills in applying a broad range of technologies used for ligand binding assays and the detection of anti-drug antibodies in biological matrices (MSD, ELISA, SPR, etc.)

• Experience in method development and validation of ADA assays

• Experience in transferring assays to external service provider labs (Contract Research Organizations)

• 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 complex problems to advance drug discovery and development programs.

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

• Demonstrated ability to identify and solve problems by applying scientific and engineering principles, preferably in a process development environment

• Demonstrated eminence in the scientific community through a sustained record of peer reviewed publications

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

Thrive

What you can expect of us

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.

• 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

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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to 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, Puerto Rico and Canada 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.