Lab Operations Manager

BioSpace; Washington (District of Columbia); On-site; USD 120,000 - 160,000; Full time

Job summary

Amgen is seeking a Lab Operations Manager to support sponsored clinical trials with a focus on laboratory operations. You will partner with suppliers, provide governance, and help optimize trial implementation on a global scale.

The role requires strong lab and clinical trials background, with potential travel up to 20% domestically or internationally. You will collaborate across study teams and partners to ensure high-quality outcomes.

Qualifications

• Doctorate or masters with lab and clinical trials experience.
• Bachelor’s with 4 years of lab and clinical trials experience or higher.
• Associates with 8 years of lab and clinical trials experience or high school with 10 years.
• Strong laboratory background, including clinical testing, central laboratory operations, or lab-related project management.

Responsibilities

• Provide guidance and input on technical and operational aspects of study design and execution
• Spearhead study startup activities and supplier-related tasks including sourcing, budget review, supplier selection, and scope of work development
• Develop global relationships with stakeholders and suppliers
• Oversee governance of laboratory suppliers and qualification processes
• Support the development and implementation of lab evaluation and monitoring standards and processes
• Ensure cross-study oversight of lab supplier performance and issue resolution
• Support trials and alignment with stakeholders, suppliers and partners for companion diagnostics development
• Participate in cross-functional initiatives with Therapeutic Areas, Early Development and Research
• Share expertise on emerging technologies and supplier governance within Amgen

Skills

Lab experience

Clinical trials experience

Regulatory understanding

Education

Doctorate degree

Masters degree

Bachelors degree

Associates degree

High school diploma

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Lab Operations Manager

What You Will Do

Lets do this. Lets change the world. 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. Come join an exceptional team that delivers for our study teams and our patients! Potentially up to 20% travel domestic and/or international.

• 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

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications.

Basic Qualifications

• Doctorate degree OR
• Masters degree and 2 years of lab and clinical trials experience OR
• Bachelors degree and 4 years of lab and clinical trials experience OR
• Associates 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.

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of 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 That May Include

• A 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
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

careers.amgen.com

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed.

Equal Opportunity

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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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, disability status, or any other basis protected by applicable law.

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. 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.