Assay Development Lead

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The Position

Job Title: Assay Development Lead

Location: Maxim Park Scotland

Role Overview

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 processensuring that deep scientific innovation is grounded in manufacturing feasibility and remains capable of transforming near-patient-care diagnostics.

Responsibilities

• 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.

Required Experience and Skills

• 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.

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.