Diagnostic Laboratory Operations Manager
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Location and Working Environment
This position is hybrid and will require you to be onsite 1 day per quarter.
Astellas’ Responsible Flexibility Guidelines Statement- At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Purpose & Scope
- The Precision Medicine and Diagnostics team is dedicated to the co-development of companion diagnostics alongside our drugs, as well as providing diagnostic testing for patient selection and stratification in clinical studies across all phases of development.
- As Diagnostic Laboratory Operations Manager, you will lead central laboratory operations for patient eligibility and biomarker stratification in clinical studies, ensuring compliance with regulatory and quality standards. You will manage vendor relationships, oversee biosample logistics, and collaborate with study teams to deliver high-quality diagnostic testing and data management support.
Role and Responsibilities
- Lead central diagnostic laboratory operations across 4–8 clinical trials within 2–4 drug programs, depending on the complexity and scope of diagnostic activities. This includes ensuring assay validation, laboratory accreditation, and quality management system compliance, while implementing corrective actions when needed.
- Collaborate with clinical and diagnostic teams on vendor assessment, selection, contracting, and execution of laboratory services, while maintaining a matrixed relationship with colleagues across Global Development Teams such as Precision Medicine & Diagnostic Leads, Alliance and Bio sample Management, Clinical Science, Data Science, Project Management, Regulatory Affairs, and Translational Medicine.
- Serve as the primary point of contact for study teams and companion diagnostic partners, managing laboratory vendors to ensure high-quality biospecimen analysis that meets contracted testing specifications.
- Oversee bio sample logistics from clinical sites to central laboratories, ensuring sample integrity, traceability, and adherence to timelines, and troubleshooting issues related to collection, processing, testing, storage, or shipment in close collaboration with vendors, clinical operations, and diagnostic partners.
Continue: Role and Responsibilities
- Work with study teams and external vendors to develop diagnostic monitoring and communication plans and ensuring accurate design of eCRFs and data transfer specifications; supporting data management with diagnostic data reconciliation for central lab outputs.
- Participate as a member of Precision Medicine & Diagnostics project teams supporting drug development and clinical trials and reporting directly to the Global Head of Precision Medicine and Diagnostics.
Required Qualifications
- Experience in lab operations and clinical research.
- Technical expertise in biomarker testing methods, including immunohistochemistry, immunofluorescence, and DNA/RNA assays.
- Experience in vendor management, contract negotiation, and human biosample logistics within clinical trials.
- Familiarity with Laboratory Information Management Systems (LIMS).
- Proven ability to lead cross-functional teams and manage multiple priorities in a fast-paced environment.
- Strong collaboration skills with the ability to present findings to both technical and non-technical stakeholders.
- BSc, MSc, PhD, or equivalent.
Preferred Qualifications
- Experience of diagnostic test development under Design Control in compliance with FDA Quality System Requirements or other Health Authority (e.g. EU, Japan, China) regulatory requirements.
- FDA IDE, EU IVDR experience for clinical studies.
What awaits you at Astellas?
- Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
- Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
- Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
- A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.
Our Organizational Values and Behaviors
- Impact
- Innovation
- Integrity
- One Astellas
- Accountability
- Courage
- Sense of Urgency
- Outcome Focus
Benefits
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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