Principal Scientist - Immunogenicity Bioanalytical Sciences

Career Category

Scientific

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.

We are seeking a Principal Scientist in our Immunogenicity Bioanalytical Sciences (IGBA) group. 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/protein therapeutics to support GLP preclinical and regulated clinical studies. You will work closely with the drug development team, research groups, and compliance to ensure suitability of the assay format for the therapeutic program.

Responsibilities include working with outsourcing teams for assay transfer to global bioanalytical CROs, contributing to regulatory filing documents, responding to regulatory review questions, and supervising or mentoring laboratory staff.

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

• Doctorate in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related field and 2 years of scientific/technical industry experience, or
• Master’s degree and 5 years of scientific/technical industry experience, or
• Bachelor’s degree and 7 years of scientific/technical industry experience.

• 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 working under Good Laboratory Practices (GLP) 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.
• Knowledge of predictive immunogenicity methods using cell‑based or ligand‑binding methods.
• 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, with strong verbal and written communication skills, high 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.

We support your professional and personal growth and well‑being through a comprehensive benefits package, a total rewards plan, and a collaborative culture. The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Additional benefits include a retirement and savings plan, group medical, dental and vision coverage, life and disability insurance, a discretionary annual bonus program, stock‑based long‑term incentives, award‑winning time‑off plans, and flexible work models where possible.

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, disability status, or any other basis protected by applicable law.

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.