Lab Operations Manager
Amgen
Summary
In this vital role you will support Amgen sponsored clinical trials, focusing on the laboratory category. In this key role, you will help us deliver on priority initiatives as well as provide strategic support to our study teams and key partners to optimize clinical trial implementation 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. Potentially up to 20% travel domestic and/or international.
Job description
- 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 partners 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
- Support 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 Supplier Governance and the wider GDO organization and support the integration activities for Amgen acquisitions, as appropriate
Basic Qualifications
- Doctorate degree OR Master’s degree and 2 years of lab and clinical trials experience OR Bachelor’s degree and 4 years of lab and clinical trials experience OR Associate’s degree and 8 years of lab and clinical trials experience OR High school diploma / GED and 10 years of lab and clinical trials experience
Preferred Qualifications
- Strong laboratory background, including clinical testing, central laboratory operations, or laboratory-related project management experience.
- Solid understanding of laboratory workflows, procedures, and operational best practices.
- Knowledge of clinical trial processes and the role of laboratory operations within clinical research.
- Experience overseeing and managing laboratory studies, projects, or research initiatives.
- Ability to coordinate cross-functional teams and ensure timely execution of study deliverables.
- Familiarity with regulatory and quality requirements applicable to clinical and laboratory environments.
Requirements
- Doctorate degree OR Master’s degree and 2 years of lab and clinical trials experience OR Bachelor’s degree and 4 years of lab and clinical trials experience OR Associate’s degree and 8 years of lab and clinical trials experience OR High school diploma / GED and 10 years of lab and clinical trials experience
- Strong laboratory background, including clinical testing, central laboratory operations, or laboratory-related project management experience.
- Solid understanding of laboratory workflows, procedures, and operational best practices.
- Knowledge of clinical trial processes and the role of laboratory operations within clinical research.
- Experience overseeing and managing laboratory studies, projects, or research initiatives.
- Ability to coordinate cross-functional teams and ensure timely execution of study deliverables.
- Familiarity with regulatory and quality requirements applicable to clinical and laboratory environments.
Benefits
- Health insurance
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance
- Retirement and savings plan
- Flexible spending accounts
- Annual bonus program
- Stock-based long-term incentives
- Time-off plans
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.