Amgen Technical Services Manager in Thousand Oaks, California
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.
The Technical Services Manager (Supplier Performance Management (SPM) Manager) role within GDO reports into a Supplier Performance Management Senior Manager supporting Amgen sponsored studies, focusing on the category of specialty labs.
Managing and developing individual and supplier-specific objectives
Developing strong global relationships with key functions and suppliers
Driving and facilitating the governance of specialty labs
Provide input on technical and operational aspects of study design and execution and support study startup with suppliers
Leading evaluation and qualification process and advising on selection of suppliers
Support the development and implementation of standards and processes for evaluation, qualification, selection, management, and monitoring of Specialty labs
Provide oversight of cross-study technical and operational performance of Specialty Lab Suppliers and manage escalated issues to resolution
Participate with Therapeutic Areas and Early Development/Translational Sciences in ongoing work streams and task forces
Share expertise in emerging technologies through company interactions, literature, and industry conferences
Contribute to the continuous improvement of Supplier Governance/SPM and the wider GDO organization
Support the integration activities for Amgen acquisitions, as appropriate
Master's degree and 3 years of clinical or scientific experience
Bachelor's degree and 5 years of clinical or scientific experience
Associate's degree and 10 years of clinical or scientific experience
High school diploma / GED and 12 years of clinical or scientific experience
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 relevant area (e.g, imaging, laboratory, device technology) and their application to clinical trials
Technical knowledge of the assigned area of focus ( specialty labs), including techniques and technologies
Knowledge of Good Clinical Practice (GCP)
Knowledge of FDA regulations and guidelines, including 21 CFR Part 11
Strong communication and Project management skills
Knowledge of QA processes
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.