Principal Scientist - Global Biosimilars

Amgen is looking for an enthusiastic and highly motivated Principal Scientist to join the collaborative and fast-paced Amgen Biosimilars team at the Amgen headquarters campus located in Thousand Oaks, CA. This team is responsible for delivering comprehensive in vitro and in vivo pharmacology to support Amgen's biosimilars development. The Principal Scientist is responsible for developing the testing plan to support the assessment of functional similarity across multiple biosimilar programs or new therapeutic programs, as well as successfully managing and executing the plan with internal and external partners. The role uses a breadth of communication expertise, both written and oral, across a broad range of stakeholders, influencing decision-making through negotiation, and delivering results by building productive working relationships across functional areas within the company.

The development of a successful preclinical pharmacology includes thorough understanding of the mechanism(s) of action of the molecule, and evaluating the potential impact to clinical efficacy, pharmacokinetics, or safety. A strong grounding in the structure/function relationship of large molecules is also required. Part of the role entails guiding "fit-for-purpose" assay qualification to support a rigorous testing plan. The Principal Scientist will manage external interactions and collaborations with partners in academia and at contract research organizations to deliver results within the comprehensive testing plan that fulfill the regulatory requirements for biological assays.

The Principal Scientist will support the biosimilar programs through the regulatory approval process in numerous jurisdictions through authoring of regulatory documents, participating in face to face discussions with regulators, and ensuring maintenance of appropriate documents in a compliant manner. Additional responsibilities include supporting the generation of abstracts, posters and publications; participating in national and international scientific meetings.

Basic Qualifications

Doctorate degree & 3 years of scientific experience

OR

Master's degree & 6 years of scientific experience

OR

Bachelor's degree 8 years of scientific experience

Preferred Qualifications:

PhD in Immunology, Pharmacology, Oncology or Translational Sciences with 7+ years experience in the Biotechnology/Pharmaceutical Industry

Excellent interpersonal skills and leadership experience with strong decision making and problem solving skills

Experience critically designing and evaluating biological assays to query diverse biology, particularly in the fields of immunology and/or oncology

Excellent oral and written communication skills supporting internal and external presentations and publications

Demonstrated track record of independent critical thinking and scientific achievement in research, exemplified by a strong publication record

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.