About the role
AI summarisedSeeking a highly motivated Senior Scientist to join the ImmunoDiagnostics team, focusing on developing regulated diagnostic products and services, particularly in protein-based assays. This role requires combining deep scientific expertise with strong project management skills to lead product development from feasibility through clinical application.
ResearchOnsiteDiagnostics Development Hub
Key Responsibilities
- Lead cross-functional project teams through product development phases, from feasibility to design transfer and verification/validation.
- Serve as the technical lead in developing a wide range of clinical applications using various technology platforms.
- Ensure compliance with good records and standard operating procedures (SOPs) according to quality system and regulatory guidelines.
- Mentor junior scientists on the latest technology developments and product landscapes.
- Manage assay planning, execution, data analysis, and troubleshooting of technical challenges.
- Contribute to product landscape studies regarding safety dossiers and technical notes approved by regulators.
- Design and contribute to clinical studies for regulated diagnostic products.
Requirements
- Education in Biochemistry, Cell Biology, Molecular Biology, Biotechnology, or a related field.
- 6-8 years of hands-on experience in protein-based assay development or IVD product development.
- 2-3 years of experience in a project or team leadership capacity.
- Strong scientific foundation with proven ability to apply first-principles methodology and critical thinking.
- Expertise in experimental design, troubleshooting, and optimization of laboratory workflows.
- Hands-on experience with pre-analytical and analytical techniques, including protein-based methods.
- Familiarity with regulatory and quality standards for diagnostic assay development (e.g., ISO13485).
- Demonstrated ability to manage complex projects and coordinate cross-disciplinary teams.