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About Us

Rapidemic is a growing start-up company based in Leiden, Zuid-Holland, dedicated to developing cutting-edge diagnostic solutions to improve the lives of patients worldwide. At Rapidemic we want to create a world where anyone can access quality diagnostics, anywhere, anytime. A world where individuals can access the care they need, and where prevention has become the standard.

Job Overview

This position as Assay and Product Development Scientist is an exciting research and development position within our diagnostic product development team. As an Assay Developer, you are responsible for the translation and integration of research results into the company’s product development pipeline, to build a verified and validated diagnostic product. You will also be working on the integration of wetware/assay technology. This role requires deep expertise in assay development, and an understanding of regulatory and quality compliance processes to drive the creation of reliable and safe diagnostic device.

Responsibilities

• Design, optimize, verify and validate assays, reagents, and components for IVD devices.

• Planning, executing and/or overseeing laboratory activities for timely achievement of product development goals.

• Interpreting results and communicating findings for strategic decision making.

• Documenting laboratory work and summarizing project progress/outcomes in project reports.

• Collaborate with cross-functional teams, including engineers, regulatory specialists, and manufacturing experts, to translate concepts into commercially viable products.

• Conduct performance evaluation to enhance device safety, accuracy and efficiency.

• Support preclinical and clinical studies in the validation phase of the product, including interfacing with/traveling to hospitals and clinics.

• Ensure compliance with relevant regulatory standards (ISO 13485, IVDR) and prepare necessary documentation.

• Analyze experimental data and troubleshoot technical challenges, applying statistical and analytical methods.

• Support scale-up processes and technology transfer from R&D to production.

• Conducting training of laboratory Technicians and Trainees on laboratory protocols/processes and biosafety.

Qualifications & Skills

• Educational Background & experience:

• PhD or Master’s degree in Biochemistry, Molecular Biology, Biomedical Engineering, or other related fields in the life sciences.

• Minimally 3 year experience working on an assay or product development

• Strong background in assay development and nucleic acid amplification testing

• Previous experience working in a regulated laboratory environment (QMS for ISO13845 and IVD(R)/MDR)

• Skills:

• Proficiency with molecular biology and biochemistry techniques: trained in molecular biology and biochemistry methods, with expertise in biochemical assays.

• Organized and Detail-Oriented: Highly organized and skilled at maintaining well-documented records.

• Team Collaboration: Work effectively in cross-functional teams within R&D, Engineering, and QA.

• Other soft skills: good communication skills, flexibility.

What we offer

• The opportunity to work on a meaningful product that is going to positively impact milions of people.

• A competitive compensation.

• Access to professional development opportunities for career growth and advancement, including training resources.

• Flexible schedule and work arrangements

• Dynamic and collaborative work environment

How to Apply

Interested? Please send your CV (saved as one PDF) and motivation letter to info@rapidemic.com with as subject “Assay & Product Development Scientist”