Principal Scientist - Immunogenicity Bioanalytical Sciences

Principal Scientist – Immunogenicity Bioanalytical Sciences

Support the design, development, validation, and implementation of assays for 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. Work closely with drug development representatives, research groups, and compliance to ensure suitability of the assay format for the therapeutic program. Collaborate with an outsourcing team to transfer assays to global bioanalytical CROs.

Contribute to regulatory filing documents and respond to regulatory review queries. Engage in multidisciplinary interactions with scientists across R&D and supervise or mentor laboratory staff.

We are seeking a scientist with the following qualifications.

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

• 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 working under 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.
• 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, 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.

• A comprehensive employee benefits package, including a retirement and savings plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan.
• Stock‑based long‑term incentives.
• Award‑winning time‑off plans.
• Flexible work models where possible.

Sponsorship for this role is not guaranteed.

Amgen does not have an Final date to receive applications for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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 receive other benefits and privileges of employment.

Please contact us to request accommodation.