Assay Development Lead

As Assay Development Lead, you are accountable for the day-to-day execution of the Lumira Assay development roadmap. Your mission is to translate product vision into prioritized, integrated work packages that cross-functional teams can deliver. As a decisive, delivery-focused matrix leader, you serve as a hands-on driver of execution for platform-based IVD tests. You orchestrate a complex ecosystem comprising R&D, Operations, Quality, Regulatory and Clinical disciplines to ensure our solutions are robust, compliant, and delivered on target. Your focus is the integrity of the assay development process-ensuring that deep scientific innovation is grounded in manufacturing feasibility and remains capable of transforming near-patient-care diagnostics., * Drive decisive day-to-day execution of complex, platform-based Near Patient Care assay development projects by translating the product vision into prioritized plans and work packages to deliver on timeline, quality, and budget.

• Foster a culture of high-impact collaboration as a cross-functional matrix leader, uniting R&D, Operations, Quality, Regulatory, and Clinical teams to instill shared ownership of project success.
• Drive proactive scenario planning and risk management, providing transparent, data-driven, high-impact communication to stakeholders regarding project state, critical path deviations, risks, and budget adherence.
• Uphold the highest standards of technical integrity and quality compliance, driving the continuous improvement of development processes through effective stakeholder engagement and feedback loops.
• Provide technical direction by applying deep scientific and diagnostic principles to solve complex execution problems, actively leading the design of alternative courses of action when technical roadblocks arise.
• Drive resource forecasting and demand planning, defining capacity and skill requirements to enable R&D (Sub-)Chapter Leads to effectively staff and supply the project.
• Partner with the business team to co-create the product roadmap, providing the critical "feasibility handshake" that ensures strategic ambitions are grounded in scientific, regulatory, and manufacturing reality.

• Industry Background: Significant experience in life sciences or engineering, with a proven track record of delivering complex projects from definition through to launch within the IVD or Medical Device industry.
• Assay Development Expertise: Profound understanding of delivering high-quality IVD assay according to diagnostic regulations incl. deep knowledge and practical experience in navigating regulatory requirements and guidelines (CLSI, IVDR, FDA (510k/CLIA), ISO, and NMPA).
• Matrix Leadership: Proven ability to navigate organizational change and technical ambiguity while leading cross-functional teams by fostering a culture of open communication to instill shared ownership for project outcomes.
• Hybrid Methodologies: Excellent knowledge of Agile/SAFe and traditional project management, translating product visions into prioritized, integrated work packages.