About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
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.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.
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.
- 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.
Essential Knowledge & Experience:
- 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.
Preferred Skills & Knowledge:
- 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.
Education:
- BSc, MSc, PhD, or equivalent.
Additional information:
- Type of role: This is a permanent role
- Location: UK
- This position follows our hybrid working model. Role requires a blend of home and minimum of 1 days per quarter in our Addlestone office. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, 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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