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Amgen

Makes biotech medicines for serious illnesses

Lab Operations Manager

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeRemote in USA

About the Job

Requirements

  • A doctorate degree, or a master's degree and 2 years of lab and clinical trials experience, or a bachelor's degree and 4 years of lab and clinical trials experience, or an associate's degree and 8 years of lab and clinical trials experience, or a high school diploma or GED and 10 years of lab and clinical trials experience.

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 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 processes for suppliers and advise partners on supplier selection.
  • Support the development and implementation of standards and processes for evaluation, qualification, selection, management, and monitoring of laboratories.
  • Provide oversight of the 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 in 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 integration activities for Amgen acquisitions as appropriate.

Desired 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.

About the Company

Amgen

Makes biotech medicines for serious illnesses

Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.

Company size
10,001+
Company stage
IPO
Headquarters
Thousand Oaks, CA
Founded
1980

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