Lab Operations Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist in Amgen-sponsored clinical trials, with a primary emphasis on the laboratory category.

• Offer strategic assistance to study teams and essential partners to enhance the implementation of clinical trials with suppliers.

• Provide expert guidance and insights on the technical and operational components of study design and execution.

• Aid in the startup and execution of studies with suppliers, encompassing sourcing, budget evaluation, supplier selection, and development of the scope of work.

• Cultivate global relationships with key stakeholders and suppliers.

• Drive and facilitate the governance of laboratory suppliers.

• Lead the processes for supplier evaluation and qualification while advising partners on their selection.

• Assist in the development and implementation of standards and processes for laboratory evaluation, qualification, selection, management, and monitoring.

• Oversee the technical and operational performance of laboratory suppliers across various studies and manage escalated issues to resolution.

• Support clinical trials and promote cross-functional alignment for the development of companion diagnostics.

• Engage in critical initiatives and task forces alongside Therapeutic Areas, Early Development, and Research.

• Share knowledge of emerging technologies through company interactions, literature, and industry conferences.

• Contribute to the ongoing enhancement of Supplier Governance and the broader GDO organization.

• Assist in integration activities related to Amgen acquisitions, as needed.

⛳️ Requirements

• Doctorate degree OR Master’s degree with 2 years of lab and clinical trials experience OR Bachelor’s degree with 4 years of lab and clinical trials experience OR Associate’s degree with 8 years of lab and clinical trials experience OR High school diploma / GED with 10 years of lab and clinical trials experience.

• Strong laboratory background, including experience in clinical testing, central laboratory operations, or laboratory-related project management.

• Comprehensive understanding of laboratory workflows, procedures, and operational best practices.

• Familiarity with clinical trial processes and the significance of laboratory operations within clinical research.

• Experience in overseeing and managing laboratory studies, projects, or research initiatives.

• Capability to coordinate cross-functional teams and ensure the timely execution of study deliverables.

• Knowledge of regulatory and quality requirements relevant to clinical and laboratory environments.

• Willingness to travel domestically and/or internationally up to 20%.

• Sponsorship for this position is not guaranteed.

🏝️ Benefits

• A comprehensive employee benefits package that includes a Retirement and Savings Plan featuring generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.

• Opportunities for career development.

• Financial plans that allow for savings towards retirement or other objectives.

• Emphasis on work/life balance.