Diagnostic Laboratory Operations Manager

Join to apply for the Diagnostic Laboratory Operations Manager role at Astellas Pharma

Diagnostic Laboratory Operations Manager

2 days ago Be among the first 25 applicants

Join to apply for the Diagnostic Laboratory Operations Manager role at Astellas Pharma

Description

Diagnostic Laboratory Operations Manager

About Astellas

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

Description

Diagnostic Laboratory Operations Manager

About Astellas

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focusing 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 focuses on the co-development of companion diagnostics in parallel with our drug programs and supports diagnostic testing for patient selection and stratification across all phases of clinical development.

In the role of Diagnostic Laboratory Operations Manager, you will oversee central laboratory operations related to patient eligibility and biomarker stratification in clinical trials. Your responsibilities will include ensuring adherence to regulatory and quality standards, managing relationships with external vendors, coordinating biosample logistics, and working closely with study teams to support the delivery of accurate diagnostic testing and reliable data management.

Hybrid Working

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.

Key Responsibilities

• Leading 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.
• Collaborating 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.
• Serving 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.
• Overseeing 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.
• Working 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.
• Participating 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.
  
  

• In-depth knowledge of biomarker testing techniques such as immunohistochemistry, immunofluorescence, and DNA/RNA-based assays.
• Skilled in managing vendors, negotiating contracts, and overseeing human biosample logistics in the context of clinical trials.
• Experienced with Laboratory Information Management Systems (LIMS).
• Demonstrated success in leading cross-functional teams and handling multiple priorities in a dynamic, fast-paced setting.
• Effective collaborator with the ability to communicate findings clearly to both technical and non-technical audiences.
  
  

• Experience in developing diagnostic tests under Design Control, in accordance with FDA Quality System Regulations and other international regulatory requirements (e.g. EU, Japan, China).
• Familiarity with FDA Investigational Device Exemption (IDE) and EU In Vitro Diagnostic Regulation (IVDR) processes for clinical studies.
  
  

• BSc, MSc or PhD with demonstrated experience in lab operations and clinical research or equivalent.
  
  

• The is a permanent full-time position based in the UK.
• This position follows our hybrid working model. Role requires a blend of home and minimum of 1 day 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.
  
  

Seniority level

• Seniority level

  Not Applicable

Employment type

• Employment type

  Contract

Job function

• Job function

  Management and Manufacturing

• Industries

  Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Astellas Pharma by 2x

Get notified about new Laboratory Operations Manager jobs in Addlestone, England, United Kingdom.

Assistant Clinical Laboratory Quality Manager

London, England, United Kingdom 1 week ago

Slough, England, United Kingdom 19 hours ago

Croydon, England, United Kingdom 3 weeks ago

Worcester Park, England, United Kingdom 3 weeks ago

London, England, United Kingdom 2 weeks ago

London, England, United Kingdom 1 week ago

Obstetrics & Gynaecology Specialty Manager

Guildford, England, United Kingdom 1 week ago

Acute Occupational Therapy Lead and Therapy Manager

Epsom, England, United Kingdom 2 days ago

London, England, United Kingdom 12 hours ago

Slough, England, United Kingdom 8 hours ago

Registered Veterinary Nurse - Medicine & Oncology Team Leader

High Wycombe, England, United Kingdom 2 months ago

London, England, United Kingdom 1 day ago

Reading, England, United Kingdom 3 weeks ago

London, England, United Kingdom 5 days ago

Reading, England, United Kingdom 6 hours ago

Marine Project Manager / Laboratory Supervisor

Marine Project Manager / Laboratory Supervisor

Guildford, England, United Kingdom 2 weeks ago

Registered Veterinary Nurse - Medicine & Oncology Team Leader

High Wycombe, England, United Kingdom £35,000 - £40,000 4 weeks ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.