• Provide validated software and automation systems to meet the laboratories requirements (life sciences, cosmetics, pharma)
• Versatile and with a strong experience gained in startup and international companies : project management, R&D, systems integration, validation, transition to mass production, support, acting as internal or external consulting team member.
• Direct (5 people) and cross-functional management of international and multidisciplinary teams
BUILD IT project management for : ¤ Information Request Management System (IRMS) ¤ Medical and Scientific publication program ¤ Investigator Sponsored Studies (ISS) Deliverables : Specific developments, system updates, data migrations and backup after company acquisitions.
RUN Lifecycle management of the IT solutions, incidents and change management (vendors and TMA)
Technical coordination and program management for the development and launch of a strategic new product line : ¤ More than 5 instruments with consumables, accessories, packaging – more than 30 reagents - 2 software ¤ Monitor the subcontractor's developments of our modular and scalable systems + multiplatform reagents (>10 international partners) ¤ Ensure the cross-compatibility of the new systems within the existing software environments (on both internal and customer sides) ¤ Achieved : delivery of serial and pre-serial systems for the validation studies
Industrialization of 2 instruments (Germany) as OEM products
Management of a validation team for In Vitro Diagnostic systems : ¤ Validation of an innovative high-throughput and multiplex system for blood banks – Technical expertise and support for project teams and the external evaluations – 2 patents, validated pre-serial instrument ¤ Validation of a system dedicated to blood infectious disease detections, CE registration and field support ¤ More than 5 validations of new biological kits (qualitative and quantitative) ¤ Change control management (hardware, firmware, software, biological) of the product range
Management of IVD R&D projects in compliance with the planning, the costs and the stakeholders requirements
Creation and management of the worldwide technical support for the 7 systems of the Transmissible Spongiform Encephalopathy product line (Bio-Rad #1 for this market) : ¤ In charge of the monthly technical committees with suppliers, change control management (new features, obsolescence) ¤ Technical trainings for the external and internal teams, creation of the online technical support portal ¤ Interface between the instrument’s manufacturers, the biological R&D, marketing teams and WW subsidiaries
Validation of a new platform, technical support for the product range in the field
Installation and qualification of 10 international "mad-cows" laboratories + local teams trainings
