Marc Flanagan

WORK HISTORY

EDUCATION

SKILLS

ABOUT MARC FLANAGAN

I work as a Senior Scientist in the R&D department at Leica Biosystems (LBS) Newcastle, an operating company of Danaher Corporation. LBS is a developer and manufacturer of diagnostics and companion diagnostics for cancer. My role centres of the compliance of our fluorescence in situ hybridisation (FISH) technologies with the in vitro Diagnostic Regulation (IVDR). This ensures that our devices are designed and developed to the highest possible standard, guaranteeing their availability to healthcare systems in Europe and beyond. I work with multiple functions - including Quality Assurance, Regulatory Assurance, Product Management and Clinical Affairs - to generate documentation and data packages for regulatory submissions.My previous role as Head of Laboratory at Magnitude Biosciences - a contract research organisation (CRO) utilising the model organism C. elegans - involved the coordination of lab staff and resources to enable the company to deliver client projects on time and in full. The company has worked extensively with clients in the pharmaceutical and nutraceutical industries, as well as academia. My role involved line management, project coordination, resourcing, budget planning, client and supplier relations, risk management, lab KPIs, recruitment, and the progression of the company towards ISO accreditation.Previously, I joined QuantuMDx in September 2012 and worked at the company until June 2024. The primary focus of the company was the portable point-of-care device, Q-POC, which is able to diagnose infectious diseases such as COVID-19 in under 30 minutes. My main role with the company was in developing and testing novel microfluidic sample preparation technologies. These technologies can rapidly extract and purify DNA and RNA from complex biological samples.In addition, I was involved in the planning and management of different assay feasibility & development projects, and assembling documentation in the form of plans, reports and standard operating procedures (SOPs). As a Senior Scientist, I oversaw the work of other researchers and helped to manage their day-to-day jobs and career progression. I also worked collaboratively with other members of staff from many different social & geographical backgrounds and specialisms, including R&D, Business Development, QA/QC, Engineering, Manufacturing and Project Management. Finally, I produced documentation and procedures to allow QMDx to comply with relevant ISO standards, attain CE-marks for assay products, and ensure compliance with e.g. FDA 510(k) and EUA requirements.