Department: Histopathology and Molecular Pathology Services
Reports To: Chief Scientific Officer
Contract Type: Full-Time, Permanent
Overall Purpose of the Role
The Senior Biomedical Scientist will play a key leadership role in the establishment, validation, accreditation, and operational management of a new Private Laboratory Histopathology Service in Dublin. Working alongside a Consultant Histopathologist, the Laboratory Manager, and multidisciplinary stakeholders, the post-holder will lead the implementation of a modern diagnostic histopathology laboratory operating in accordance with ISO 15189:2022 accreditation requirements and international best practice standards.
Initially, the service will focus on routine histopathology testing including H&E staining and selected immunohistochemistry assays. The successful candidate will be responsible for developing laboratory workflows, validating instrumentation and methods, implementing quality systems, and supporting accreditation activities.
The role requires close collaboration with equipment manufacturers, pathology software providers, and Laboratory Information Management System (LIMS) developers to establish an efficient, technology-enabled pathology service.
The organisation currently operates an accredited molecular pathology service under ISO 15189, and the successful candidate will contribute to the oversight, expansion, and integration of molecular diagnostics within the wider pathology service, including supporting future service development opportunities.
Key Responsibilities
Service Development and Implementation
- Lead the establishment of a new histopathology laboratory service from planning through to operational delivery.
- Collaborate with equipment vendors and technical specialists to install, qualify, verify, and validate laboratory instrumentation and associated systems.
- Develop and implement laboratory workflows, standard operating procedures (SOPs), validation protocols, and technical documentation.
- Support the introduction of new diagnostic technologies and methodologies to enhance service capability and efficiency.
- In co-operation with Consultant Histopathologist, Chief Scientific Officer, Medical Scientists, Laboratory Manager and other designated senior staff, participate in the introduction of new ideas and methods
- Work with LIMS providers to implement and optimise laboratory information systems, ensuring full traceability and compliance with accreditation standards.
- Assist in developing operational processes that maximise quality, efficiency, and resource utilisation.
- Participate as required in the registration, custody and stock level of the Laboratory reagents and other materials held in the Pathology Department
Scientific and Technical Responsibilities
- Perform and supervise scientific and technical activities within the Histopathology Department to the highest professional standards.
- Ensure diagnostic testing is performed in accordance with established procedures, regulatory requirements, and accreditation standards.
- Manage and coordinate multiple workstreams while maintaining service quality and turnaround times.
- Contribute specialist scientific expertise to service development initiatives, assay implementation projects, and technology evaluations.
- Identify professional training requirements of medical scientist staff as appropriate.
Quality and Accreditation
- Support the implementation, maintenance, and continuous improvement of the Quality Management System in accordance with ISO 15189:2022.
- Participate in accreditation activities, audits, inspections, and quality improvement programmes.
- Maintain compliance with all laboratory policies, procedures, professional standards, and regulatory requirements.
- Investigate non-conformances, incidents, complaints, equipment issues, and quality events, implementing corrective and preventive actions as required.
- Actively participate in internal quality control, external quality assessment (EQA), and proficiency testing programmes.
- Promote a culture of continuous quality improvement and patient safety.
- Ensure compliance with all relevant health, safety, and environmental regulations.
- Promote safe working practices in accordance with the Safety, Health and Welfare at Work Act and organisational policies.
- Participate in risk assessments, incident investigations, and the implementation of risk mitigation measures.
- Support the development and maintenance of procedures designed to prevent and manage laboratory accidents and safety incidents.
Leadership and Staff Development
- Provide day-to-day leadership and technical supervision to laboratory staff.
- Support recruitment, onboarding, competency assessment, training, and professional development activities.
- Assist in workforce planning and resource allocation to ensure effective service delivery.
- Monitor laboratory performance metrics and contribute to service reporting and operational reviews.
Finance
- Ensure, in collaboration with the Chief Scientific and Laboratory Manager, that expenditure is controlled within budget and identify potential for efficiency savings through improved practices and innovation.
Person Specification
- CORU registered Medical Scientist.
- Bachelor's degree in Biomedical Science, Medical Laboratory Science, or an equivalent qualification.
- Significant post-registration experience in Histopathology within an accredited diagnostic laboratory.
- Have had at least five years’ experience in a medical laboratory since qualifying as a medical scientist
- Demonstrated knowledge and practical experience of ISO 15189:2022 and laboratory quality management systems.
- Demonstrate the ability to develop and implement standard operating procedures
- Experience in method validation, verification, equipment qualification, and implementation of new diagnostic services.
- Strong organisational, leadership, and project management skills.
- Demonstrate flexibility and openness to change with the needs of the service;
- Excellent communication, teamwork and interpersonal abilities.
- Proven ability to work independently and lead complex service development initiatives.
- MSc or higher qualification in Histopathology, Biomedical Science, Molecular Pathology, or a related discipline.
- Previous experience establishing or commissioning a new laboratory service.
- Experience working with laboratory information management systems (LIMS) and digital pathology solutions.