Scientist, Immunogenicity Bioanalytical

Amgen SA; Thousand Oaks (CA); Hybrid; USD 110,000 - 150,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based incentives

Flexible time-off

Job summary

Amgen is seeking a Scientist, Immunogenicity Bioanalytical to develop, validate, and implement sensitive assays for anti-drug antibodies and pre-existing antibodies in nonclinical and clinical studies. You will work in a lab-based role, ensuring data quality and regulatory alignment, and collaborating across teams.

You will review complex data, report findings, and support automation and technology development while advancing immunogenicity risk assessment and candidate selection early in

Qualifications

• Doctorate degree (PhD) in a relevant field or Master’s with immunogenicity bioanalytical experience or Bachelor’s with immunogenicity bioanalytical experience.
• Experience with regulated bioanalytical assays and method transfer to CROs preferred.
• Strong understanding of immunology, antibody biology, or related field and ability to work in fast-paced environment.

Responsibilities

• Develop, validate, and implement bioanalytical methods for ADA and pre-existing antibodies.
• Review and interpret scientific data, prepare reports, and present results.
• Contribute to immunogenicity risk assessment and regulatory submissions.
• Coordinate with project teams and external CROs for assay development and transfer.
• Maintain awareness of evolving regulatory expectations and provide scientific oversight.

Skills

Immunogenicity

Bioanalysis

Regulatory knowledge

Education

PhD in Immunology

Master's in Immunology

Bachelor's in related field

Tools

MSD Bioassays

GLP/GCP experience

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

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.

Scientist, Immunogenicity Bioanalytical

What you will do

Let’s do this. Let’s change the world. In this vital role you will develop, validate, and implement bioanalytical methods for detection and characterization of anti-drug antibodies (ADA) in nonclinical and clinical studies. This assessment is important for understanding the immunogenicity profile of therapeutic molecules and its potential impact. You will ensure that immunogenicity assays and data are scientifically robust, fit for purpose, and aligned with current regulatory expectations. Through collaboration with project team representatives, external service provider labs, and other functional areas, you will contribute to immunogenicity risk assessment, regulatory submissions, and informed decision-making throughout drug development.

The position is lab-based, and additional responsibilities will include critically reviewing and interpreting scientific data and results, report generation, project management, communication of results, data presentations, supporting automation efforts, and keeping current with technology development.

In addition to regulated ADA bioanalysis, you will work on research focused work to understand and manage pre-existing antibody reactivity. This work requires critical scientific thinking to identify molecule specific assay challenges, design novel assay formats and reagents, and generate data that informs immunogenicity risk assessment and candidate selection early in development.

Key Responsibilities

• Develop and optimize sensitive, specific, and robust anti-drug antibody and pre-existing antibody assays using appropriate bioanalytical platforms and technologies (e.g., electrochemiluminescence based MSD).
• Design and execute validation of ADA methods in accordance with current regulatory guidance, industry best practices, and internal scientific standards.
• Conduct sample analysis in accordance with GLP and GCP guidelines
• Author and review bioanalytical documents, including validation reports and nonclinical/ clinical sample analysis study reports
• Develop appropriate mitigation strategies for challenging assay conditions, including high circulating drug concentrations, soluble target interference, pre-existing reactivity, matrix effects, and other molecule specific factors.
• Design and execute pre-existing antibody screening assays to support the pipeline, characterize molecules with positive pre-ADA reactivity using novel assay approaches, and independently apply critical scientific thinking to develop new strategies for complex therapeutic modalities.
• Provide scientific oversight of bioanalytical work conducted internally and/or at external CRO laboratories
• Maintain awareness of evolving regulatory expectations and advances in immunogenicity bioanalysis and apply relevant developments to bioanalytical strategies.
• Contribute to scientific innovation through evaluation of new technologies and development of improved methodologies

What we expect of you

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

Basic Qualifications:

Doctorate degree PhD

OR

Master’s degree and 2 years of Immunogenicity Bioanalytical experience

OR

Bachelor’s degree and 4 years of Immunogenicity Bioanalytical experience

Preferred Qualifications:

• Prior experience in pharma/biotech strongly desired.
• Prior GLP and GCP experience.
• Prior experience in bioanalytical (regulated) assay execution and method transfer to external contract laboratories.
• Understanding of immunology, immunogenicity, antibody biology, or a related field.
• Must be willing to work in a fast-paced, multi-project environment with high workload demands, and consistently deliver high-quality results within established timelines.
• Demonstrated ability to efficiently resolve scientific challenges, prioritize and effectively manage multiple projects.
• Excellent scientific problem-solving skills.
• Excellent project and time management abilities.
• Ability to work collaboratively with internal and external stakeholders.

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include:

• 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. Refer to the Work Location Type in the job posting to see if this applies.

Application deadline

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

Sponsorship

Sponsorship for this role is not guaranteed.

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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. 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.