Supplier Performance Management Lab Operations Manager

The Supplier Performance Management (Technical Services) Manager role within Global Development Operations (GDO) reports into a Supplier Performance Management Senior Manager and supports Amgen sponsored clinical trials, focusing on the laboratory category. In this key role, by leveraging scientific laboratory background and clinical trial experience, you will help us deliver on priority initiatives as well as provide strategic support to our study teams and key stakeholders to optimize clinical trial execution with our suppliers. The highest quality will be achieved by partnering effectively with our suppliers and providing robust supplier oversight with a fit for purpose governance program.

Our scope is global and supports our clinical trials around the world. Come join an exceptional team that delivers for our study teams and our patients!

Potentially up to 20% travel domestic and/or international.

Responsibilities:

• Provide guidance and input on technical and operational aspects of study design and execution
• Provide support and guidance during study startup and conduct with suppliers including activities such as sourcing, budget review, supplier selection, and scope of work development
• Develop strong global relationships with key stakeholders and suppliers
• Drive and facilitate the governance of laboratory suppliers
• Lead evaluation and qualification process of suppliers and advise stakeholders on their selection
• Support the development and implementation of standards and processes for evaluation, qualification, selection, management, and monitoring of labs
• Provide oversight of technical and operational performance of laboratory suppliers across studies and manage escalated issues to resolution
• Participate on key initiatives and task forces with Therapeutic Areas, Early Development and Research
• Share expertise in emerging technologies through company interactions, literature, and industry conferences
• Contribute to the continuous improvement of SPM, Supplier Governance and the wider GDO organization
• Support the integration activities for Amgen acquisitions, as appropriate

Basic Qualifications:

Doctorate degree

OR

Master's degree and 3 years of clinical or scientific experience

OR

Bachelor's degree and 5 years of clinical or scientific experience

OR

Associate's degree and 10 years of clinical or scientific experience

OR

High school diploma / GED and 12 years of clinical or scientific experience

Preferred Qualifications:

• 7+ years' work experience in life sciences or medically related field, including 4+years of biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical, CRO or technical services supplier)
• Technologist or work experience in laboratory area with application to clinical trials
• Technical knowledge of labs, including techniques and technologies
• Familiarity with oncology including current lab methodologies
• Knowledge of Good Clinical Practice (GCP), ICH, FDA regulations and guidelines, including 21 CFR Part 11
• Strong communication and Project management skills
• Knowledge of QA processes
• Ability to develop collaborative internal and external relationships
• Excellent interpersonal, organizational, and critical thinking skills

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.

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.