Principal Scientist - Immunogenicity Bioanalytical Sciences

About the Role

Amgen's Pharmacokinetics & Drug Metabolism and Bioanalytical Sciences (PKDM-BA) organization is seeking a Principal Scientist in the 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. 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.

Responsibilities

• Collaborate closely with representatives from the drug development team, research groups, and compliance to ensure suitability of the assay format for the therapeutic program.
• Work closely with an outsourcing team for the transfer of assays to global bioanalytical CROs.
• Contribute to regulatory filing documents and provide responses to questions received upon regulatory review.
• Engage in highly multidisciplinary interactions with scientists across research and development at Amgen.
• Supervise or mentor laboratory staff.

Basic Qualifications

• Doctorate in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related field (and relevant post-doc where applicable) with 2 years of scientific/technical industry experience OR
• Masters degree with 5 years of scientific/technical industry experience OR
• Bachelors degree with 7 years of scientific/technical industry 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 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, with strong verbal and written communication skills and 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.

Benefits & Compensation

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities. This includes:

• 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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is available upon request. Actual salary will vary based on several factors including but not limited to relevant skills, experience, and qualifications.