At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ®–– one of the first multiplexing and multimodality automated testing platforms––are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.

DEPARTMENT LEADER, PRODUCT DEVELOPMENT

AliveDx is recruiting for a Department Leader to join the Product Development team based near Edinburgh (EH26 0BF). The role is a full-time, permanent role, working 37.5 hours per week.

The role is designed to lead, manage and provide scientific direction across all aspects of product/process development projects in relation to Alba products. All in accordance with operational objectives, statutory and regulatory requirements, and the principles of GMP in support of products which are marketed worldwide. This will often involve interaction with external parties. Accountable for delivery of projects to timelines and quality expectations.

YOUR MISSION

Your main responsibilities will include:

• Manage the product development activities of Alba products to ensure customers’ needs, strategic objectives and performance targets are met.
• Provide expertise in assay development, product validation, product requirement definitions and licensure.
• Deputise for the Head of Department in product development areas, to drive scientific solutions as required.
• Own/manage custom and complex projects, working with Project Management, troubleshooting and technical/scientific issues to ensure continuous improvement/development of products and processes.
• Analysis and interpretation of complex data sets is required along with report writing for regulatory approval of Alba products, this includes progress reports with conclusions and proposed actions.
• Chair technical reviews and provides departmental training. Leads scientific workshops to address cross-departmental assay issues, ensuring flawless transition from feasibility to development through to validation and then into commercial approval.
• Lead and troubleshoot complex issues regarding reagent quality and assay robustness, offering support to the wider R&D team as necessary.
• Assist the department in general organisation and administration of laboratory facilities, such as documentation and audits to ensure departmental compliance with health and safety, GMP/GLP standards.
• Assist with the preparation of documentation for regulatory applications including performance evaluations.
• Organisation of routine work within the department to maximise the use of available resources.
• Undertake supervision, training, and appraisals of junior staff to ensure that staff with appropriate skills and knowledge of laboratory organisation and procedures are available to meet the requirements of the department's planned programmes of work.