Supplier Performance Management - Lab Operations Manager/Clinical Trials

Career Category
Clinical
Job Description
HOW MIGHT YOU DEFY IMAGINATION?
You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Supplier Performance Management - Lab Operations Manager
Live
What you will do
Let's do this. Let's change the world. In this vital role you will be part of Amgen's Global Development Operations (GDO), which reports into a Supplier Performance Management Senior Manager and supports Amgen sponsored clinical trials, focusing on the laboratory category. In this key role, you will help deliver on priority initiatives as well as provide strategic support to our study teams and key partners 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.
This is a preferred Hybrid role, to work remote (locally) and work onsite in Thousand Oaks a couple of days a month or as needed for on site for engagement or essential meetings.
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 partners and suppliers; drive and facilitate the governance of laboratory suppliers
• Lead evaluation and qualification process of suppliers and advise customers 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 handle escalated issues to resolution
• Support supplier strategy and oversight for clinical biomarkers
• Support execution of clinical trials and cross functional alignment with stakeholders, suppliers and partners for companion diagnostics development
• 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.

Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The qualified professional we seek is experienced with these qualifications.
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, techniques and technologies, including clinical molecular diagnostics, anatomical pathology, biomarker development, assay validations.
• 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 with excellent interpersonal, organizational, and critical thinking skills

Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Salary Range
99,761.00 USD - 125,186.00 USD