Sr. Principal Scientist - Immunogenicity Bioanalytical Sciences

Amgen Inc. (IR); Thousand Oaks (CA); On-site; USD 166,000 - 224,000; Full time

Job summary

Amgen Inc. invites applications for a Sr. Principal Scientist in Immunogenicity Bioanalytical Sciences. You will lead immunogenicity assay development, validation, and transfer, collaborating with cross-functional teams and CRO partners to ensure regulatory compliance and robust data generation.

The role requires a PhD with extensive experience in ADA/NAb assay strategies, GLP/GCP, and regulatory interactions, along with strong leadership and communication skills for matrixed project work.

Qualifications

• PhD in Biochemistry, Molecular Biology, Cell Biology, Immunology or related field with relevant post-doc experience
• Strong experience in development, validation, and oversight of immunogenicity assays
• Familiarity with GLP/GCP and regulatory guidelines in immunogenicity

Responsibilities

• Provide scientific leadership for immunogenicity assay development and validation.
• Oversee assay transfers to CROs and ensure quality and timelines.
• Interpret complex data and troubleshoot to support regulatory submissions.
• Mentor scientists and contribute to capability-building in the team.

Skills

Immunogenicity assays

Regulatory guidance

Data interpretation

Team mentoring

Education

PhD in Biochemistry/Molecular Biology/Immunology

Tools

CRO transfer

Job description

Career Category Scientific 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.

Sr. Principal Scientist – Immunogenicity Bioanalytical Sciences

What you will do Let’s do this. Let’s change the world. The Pharmacokinetics & Drug Metabolism and Bioanalytical Sciences (PKDM-BA) organization is seeking to fill a Sr. Principal Scientist position 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. 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. This role will involve close collaboration with representatives from the drug development team, research groups, and compliance to ensure suitability of the assay format for the therapeutic program. You will work closely with an outsourcing team for the transfer of assays to global bioanalytical CROs. You will also be responsible for contributing to regulatory filing documents and for providing responses to questions received upon regulatory review. 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.

Key Responsibilities

Provide scientific and strategic leadership for immunogenicity assay development, validation, transfer, and implementation across nonclinical and clinical programs. Serve as a senior subject-matter expert for ADA, NAb, drug-tolerant, cell-based, and predictive immunogenicity assay approaches. Apply deep knowledge of global regulatory guidance, GLP/GCP expectations, and statistical assay validation principles to guide program decisions. Lead complex data interpretation, troubleshooting, and risk assessment to support immunogenicity bioanalytical strategy. Provide scientific oversight of assay transfers to CROs, lead troubleshooting efforts while ensuring scientific quality, compliance, and timeline delivery. Influence cross-functional program teams and senior stakeholders in a matrixed environment. Mentor scientists and lead efforts to contribute to functional capability building, innovation, and best-practice development.

Basic Qualifications

• Doctorate in Biochemistry, Molecular Biology, Cell Biology, Immunology, or a related field [and relevant post-doc where applicable] and 3 years of scientific/technical industry experience OR Master’s degree and 6 years of scientific/technical industry experience OR Bachelor’s degree and 8 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 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
• 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

What you can expect of us

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.

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.

Equal Opportunity and Disability Accommodation

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.

Salary Range

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.

Salary Range 165,500.95USD -223,913.05 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen