Principal Scientist - Immunogenicity Bioanalytical Sciences

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnesses drives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Lets do this. Lets change the world. The Pharmacokinetics & Drug Metabolism and Bioanalytical Sciences (PKDM-BA) organization is seeking to fill a 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 Amgens 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.

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 relevant post-doc where applicable] and 2 years of scientific/technical industry experience
• OR
• Masters degree and 5 years of scientific/technical industry experience
• OR
• Bachelors 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 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…