Department Leader, Alba Haematology

Building on 30 years of experience in transfusion diagnostics, AliveDx is committed to delivering solutions that reshape the way diagnostics is practiced.  AliveDx has two key product portfolios, Alba by Quotient™ and MosaiQ™ by Quotient. The Alba by Quotient™ product range is comprised of high-quality reagents used to keep laboratories around the world running efficiently. They are sold directly to laboratories or through our OEM partners. MosaiQ™ by Quotient is our proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. AliveDx operations are based in Eysins, Switzerland, Edinburgh, Scotland and Chicago, Illinois.

Department leader, ALBA HAEMATOLOGY

We are recruiting for a Department Leader to join our Alba Product Development Team based at our ARC site near Penicuik, EH26 0BF. This role is a full-time, permanent position working 37.5 hours per week. Monday-Friday.

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

JOB DESCRIPTION
The main responsibilities will include:

• Manage the product development activities for Alba Haematology products to ensure customer needs, strategic objectives and performance targets are met.
• Provide expertise in assay development, product validation, product requirement definitions and licensure.
• Own/manage custom and complex Haematology projects, working with Project Management and Manufacturing teams on 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 Haematology products, this includes progress reports with conclusions and proposed actions.
• Chairs technical reviews and provides departmental training. Leads scientific workshops to address cross-departmental issues, ensuring flawless transition from feasibility to development through to validation and then into commercial approval.

QUALIFICATIONS, EXPERIENCE & BEHAVIOURS REQUIRED

• Science Degree is essential.
• Relevant experience in appropriate regulated laboratory/environment e.g. medical devices, pharma
• Product development and optimisation experience.
• Experience in recording and reporting on experimental outcomes).
• Data analysis and interpretation skills.

• Ability to effectively communicate and work across departments and in cross-disciplinary teams (e.g. regulatory affairs, commercial)
• Excellent attention to detail.

ADDITIONAL INFORMATION

• Competitive salary on offer.
• AliveDx offer a range of core and flexible benefits ranging from private medical cover, life assurance, cycle to work, technology, and restaurant discounts.