Amgen Senior Scientist- Medical Sciences Clinical Immunology in Thousand Oaks, California
Amgen is a values based organization with a powerful sense of shared purpose toward our mission: to serve patients. At our Thousand Oaks and San Francisco facilities, we provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and verve that marked our early days as a biotechnology pioneer. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this:
We are seeking a highly motivated Senior Scientist to join the Clinical Immunology group within Medical Sciences responsible for providing project and scientific oversight of the immunogenicity component of drug development for a diverse portfolio of Amgen clinical development products including biosimilars.
Author key regulatory, clinical study and technical documents.
Manage productive collaborations cross-functionally within Amgen's matrix environment and externally through publications and presentations
Ensure that the immunogenicity components of studies are conducted in compliance with the protocol and applicable guidelines / regulations.
Interpret immunogenicity results and assess potential impact on exposure, safety and efficacy.
Doctorate degree and 2 years of scientific experience
Master's degree and 5 years of scientific experience
Bachelor's degree and 7 years of scientific experience
PhD in immunology, cell biology, biochemistry or related discipline with 5+ years of experience in the biotechnology industry
Detailed knowledge of immunology and immunogenicity-related assays
Knowledge of anti-drug antibody (ADA) impact analysis and ability to participate in a cross-functional teams to define and report impact
Experience in the clinical development of Immuno-oncology biologic drugs
Knowledgeable regarding quality attributes leading to immunogenicity risk
Knowledge of global regulatory guidelines related to immunogenicity assessment
Excellent communication skills and ability to influence and lead teams
A Fortune 150 company operating in nearly 100 countries around the world, we invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients. That's why, as a member of our cross functional, cross discipline team, we provide you with valuable opportunities to broaden your experience and maximize your potential. Focused on the industry's most
compelling scientific discoveries and housed within industry leading facilities within the heart of the world's leading biotechnology hub, our colleagues are growing our pipeline through groundbreaking innovations. We believe in rewarding those who do rewarding work and are committed to providing careers that can help turn the tide of serious, life interrupting illnesses.
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.