Scientist - In Vitro Diagnostics

Amgen is seeking a Scientist - In Vitro Diagnostics to work out of either Amgen's Thousand Oaks or South San Francisco CA sites. Integral to the ongoing success of Amgen's comprehensive biomarker programs, the Translational

Medicine In Vitro Diagnostics (IVD) Group is responsible for the transition of exploratory biomarkers to marketed IVDs, working with other functions within Amgen to identify the appropriate partner for diagnostic test development. The role uses a wide breadth of communication expertise across a broad range of partner, influencing decision-making through negotiation, and addressing conflict by building productive working relationships across functional areas both within and outside the company.

Position Responsibilities

Implementing companion diagnostic development strategies through integration of functional stakeholder input.

Working with third party companion diagnostic partners to develop project plans including resource identification, budget, facility and regulatory requirements to meet project goals and clinical timelines.

Leading internal and external cross-functional teams required to manage and execute external diagnostic development partnerships with third parties from inception through regulatory approval in multiple jurisdictions.

Basic Qualifications

Doctorate degree
Or

Master's degree and 3 years of companion diagnostic development experience
Or

Bachelor's degree and 5 years of companion diagnostic development experience

Preferred Qualifications

• Ph.D in Molecular Biology, Cell Biology, Immunology or Genomics
• Subject matter expert with proven pharma-facing experience developing companion diagnostics in alignment with drug development programs.
• Poise and professionalism with strong communication and influencing skills in a dynamic and changing environment.
• R&D experience in companion diagnostics development and knowledge of regulatory submission requirements of in vitro diagnostic devices in multiple markets.
• Experience integrating data from multiple sources and identifying critical process variables.
• Experience establishing and reviewing complex plans for multiple projects or activities. This includes planning resource allocation and distribution and identifying risks and contingency plans.
• Understanding of clinical study design and operational considerations associated with the alignment of companion diagnostic and pharmaceutical clinical trials.
• 5+ years of experience in the biopharmaceutical or diagnostics industry

At Amgen, our mission is serving patients. Our staff is dedicated to pushing the boundaries of science to transform medicine and turn the tide on serious illnesses. Central to achieving this mission is our "people-first" philosophy. We recruit the best talent, build an environment that facilitates career growth, and provide staff with the opportunity to make significant contributions for patients and our business.

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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen cultivates an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status. Amgen will consider for employment qualified applicants with criminal histories in a manner consistent with the San Francisco Fair Chance Ordinance.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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, or disability status.