Principal Scientist Immunogenicity Bioanalytical

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Principal Scientist Immunogenicity Bioanalytical

What you will do

Let’s do this. Let’s change the world. The Translational Safety and Bioanalytical Sciences (TS&BA) organization is seeking to fill a Principal Scientist position in our Immunogenicity Bioanalytical Sciences (IGBA) group at the Amgen Thousand Oaks site in California. In this vital role you will support the design, development, validation, and implementation of assays for the detection of binding and neutralizing anti-drug antibodies (ADAs & NAbs) for Amgen’s large molecule therapeutics to support GLP preclinical and regulated clinical studies. Such molecules will inherently be diverse in nature and will require technical expertise in the implementation of suitable and innovative immunogenicity methods in accordance with global regulatory guidelines. Given the breadth of projects, this role will involve highly multidisciplinary interactions with scientists across research and development at Amgen and will provide an opportunity to supervise or mentor laboratory staff.

• Collaborate with representatives from the drug development team, research groups, and compliance to ensure suitability of the assay format for the therapeutic program. The individual will work closely with an outsourcing team for the transfer of assays to global bioanalytical CROs

• Work closely with an outsourcing team for the transfer of assays to global bioanalytical CROs.

• Contribute to regulatory filing documents and for providing responses to questions received upon regulatory review.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is an individual with these qualifications.

Basic Qualifications:

• Ph.D. in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related field with 1-3 years industrial or postdoctoral experience

Or

• Master’s degree and 5 years of scientific/technical experience

Or

• Bachelor’s degree and 7 years of scientific/technical experience

Preferred Qualifications:

• Demonstrated expertise in the development, validation, and oversight of immunogenicity assays for detection of anti-drug binding and neutralizing antibodies according to current global regulatory guidelines

• Experience of working under the Good Laboratory Practices (GLPs) and knowledge of Good Clinical Practices (GCP) guidelines

• Experience in the transfer of immunogenicity assays to bioanalytical CROs

• Knowledge of statistical approaches applied to immunogenicity assays

• Knowledge of drug-tolerant assay formats for ADA and NAb detection

• Knowledge of cell-based assay formats for NAb detection

• Supervisory and mentoring experience in a lab setting.

• Ability to analyze and interpret data to assist in assay development, validation, and troubleshooting.

• Ability to multi-task and manage multiple projects, strong verbal and written communication skills with a high degree of motivation, creativity and collaborative qualities.

• Previous experience working in a matrixed environment to implement immunogenicity assay development, validation, and sample analysis

• Project management skills to meet critical timelines associated with various activities necessary to support nonclinical and clinical studies.

• Ability to collaborate with cross-functional teams while also working independently

• Commitment to diversity and equity while creating a welcoming and inclusive work environment

What you can expect of us

As we work to develop treatments that take care of others, we also w