Principal Scientist - Immunogenicity Bioanalytical Sciences

Amgen•Thousand Oaks, CA

About The Position

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. 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 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.

Requirements

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 Master’s degree and 5 years of scientific/technical industry experience OR Bachelor’s degree and 7 years of scientific/technical industry experience

Nice To Haves

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

Responsibilities

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.
Implementation of suitable and innovative immunogenicity methods in accordance with global regulatory guidelines.
Close collaboration 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.
Responsible for contributing to regulatory filing documents and for providing responses to questions received upon regulatory review.
Supervise or mentor laboratory staff.

Benefits

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
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

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