Sr Associate Scientist - Human Tissue Science Center

Amgen is seeking a highly motivated individual to join the Human Tissue Science Center (HTSC), within the Department of Clinical Biomarkers and Diagnostics (CBD).

Reporting to the HTSC Lead, the Senior Associate Scientist will develop study specification protocols to prospectively collect high quality human tissue specimens and associated clinical data for specific portfolio related questions on target expression and biomarker assay development. This role will collaborate with teams and manage studies across Amgen R&D.

Responsibilities include:

• Design and manage complex human tissue studies in cross functional collaboration with Amgen teams, external vendors, and CROs
• Ensure compliance with regulations related to human subject research, specimen collection, and data management
• Review and highlight any quality concerns with specimens or associated human clinical data; resolve with CRO and management as needed
• Author and review SOPs, project specific protocols, case report forms (CRFs), and biospecimen collection procedures
• Proactive, ongoing review of current CRO network and identification of new potential CROs
• Collaborate with Amgen Legal to initiate/update master agreements with CROs
• Collect key performance indicators and prepare metric assessment reports
• Experience with database requirements and review a plus

Basic Qualifications

Master's degree and 4 years directly related scientific experience

OR

Bachelor's degree and 6 years directly related scientific experience

OR

Associate degree and 8 years directly related scientific experience

Preferred Qualifications

• Degree in allied health, biological, or life sciences
• Medical Technologist Certification a plus
• Ability to focus on key issues and be result oriented
• Familiarity with medical and scientific terminology
• Clinical trial management experience
• Possess initiative, independence, flexibility, willingness to learn, ability to embrace challenges, and a strong commitment to quality
• Excellent interpersonal, verbal, and written communication skills
• Detail oriented, proactive, ability to work independently and in teams
• Proficiency with Microsoft Excel, Word, Sharepoint, and document management applications
• Familiarity with databases and data analysis software (StarLIMS, Access, Smartsheet, Visio, Tableau, etc.)
• Strong organizational, time, and project management skills; ability to prioritize, plan and facilitate meetings, identify and track progress on action items
• Previous knowledge or experience in a histology/pathology/laboratory environment -clinical lab experience a plus
• Familiarity with QA/QC/GxP/CAP/CLIA regulations a plus

Location - Remote (CA) or Thousand Oaks, CA

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, 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.

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.

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.