Assay Development Lead

Roche Holding AG

Maxim Park, Scotland, United Kingdom
**
Ivd assay development experience
Clsi ivdr fda iso nmpa regulations
Cross-functional matrix leadership
** Roche Holding AG is seeking an Assay Development Lead for their location in Maxim Park, Scotland. The role involves overseeing the execution of complex assay development projects, ensuring compliance with diagnostic regulations, and fostering collaboration across cross-functional teams. **

Job Summary

  • The role is accountable for the day-to-day execution of the Lumira Assay development roadmap to deliver robust, compliant solutions.
  • You will serve as a decisive, delivery-focused matrix leader uniting R&D, Operations, Quality, Regulatory, and Clinical teams.
  • Roche offers a culture that encourages personal expression, open dialogue, and genuine connections where every voice matters.

Matching Summary

Match Score: 75

** Roche Holding AG is seeking an Assay Development Lead for their location in Maxim Park, Scotland. The role involves overseeing the execution of complex assay development projects, ensuring compliance with diagnostic regulations, and fostering collaboration across cross-functional teams. **

Skills & Requirements

Must-have

  • IVD assay development experience
  • CLSI IVDR FDA ISO NMPA regulations
  • Cross-functional matrix leadership
  • Agile SAFe project management
  • Resource forecasting and planning

Nice-to-have

  • Deep scientific diagnostic principles
  • Proactive scenario planning skills
  • Culture of open communication
  • Hands-on delivery focus
  • Continuous improvement mindset

Key Requirements

  • Significant IVD or Medical Device industry background
  • Proven track record delivering complex projects from definition to launch
  • Deep knowledge of navigating CLSI, IVDR, FDA, ISO, and NMPA guidelines

Work Rights

Not specified

Tailored Resume

Cover Letter