Head of Assay Development

Head of Assay Development

About Us

At Rapidemic, we’re developing the next generation of molecular diagnostics, combining cutting-edge assay science with innovative hardware to deliver impactful diagnostic solutions. As a growing and ambitious company, we offer a collaborative, low-hierarchy environment where scientific excellence, innovation, and ownership go hand in hand. As our Head of Assay Development, you will provide the scientific and technical leadership required to transform assay concepts into robust, scalable, and regulatory-ready diagnostic products. You will own the assay development strategy across the entire product lifecycle—from early research and feasibility through verification, validation, commercialization, and beyond. Reporting directly to the CEO and working closely with the Head of Engineering and Head of QA/RA, you will play a critical role in shaping both our products and our technical direction. As a key member of the leadership team, you will ensure seamless integration between wetware and hardware development, help navigate technical risks and opportunities, and contribute to strategic decisions that drive product performance, differentiation, and future growth. This is a unique opportunity for a hands-on scientific leader who thrives in a dynamic environment and wants to help build diagnostic technologies with the potential to improve healthcare worldwide.

Job Overview

You will join a multidisciplinary team of scientists, engineers, quality professionals, and product experts who are passionate about solving complex healthcare challenges. At Rapidemic, we value scientific rigor, ownership, transparency, and collaboration. You will manage and work closely with Assay Development Scientists, the Engineering department, Quality Assurance and Regulatory Affairs specialists and Manufacturing teams. Together, you’ll create integrated diagnostic solutions that move seamlessly from concept to commercialization.

This is a contract for at least 36 hours per week. We evaluate candidates on a rolling basis and seek to fill this position as soon as possible.

Role & Responsibilities

Lead Assay Strategy

• Define and own the assay development roadmap from concept through commercialization and post-market support.
• Translate clinical needs and product requirements into assay specifications and development plans.
• Provide scientific leadership and technical decision-making across projects.

Drive Development and Delivery

• Lead assay design, optimization, verification, and validation activities.
• Oversee robustness, stability, and shelf-life studies.
• Guide technology transfer and manufacturing scale-up activities.
• Identify technical risks early and implement mitigation plans.

Build Integrated Products

• Partner closely with Engineering to develop a fully integrated wetware-hardware diagnostic system.
• Drive design-for-manufacturing and scalability considerations from the earliest development stages.
• Collaborate across Quality, Regulatory, Manufacturing, Product, and Clinical teams.

Lead and Grow the Team

• Build and develop a high-performing assay development function.
• Foster a culture of accountability, collaboration, innovation, and scientific excellence.
• Create clarity around priorities, ownership, and professional development.

Support Quality, Regulatory, and IP Activities

• Ensure compliance with applicable IVD regulations and quality standards.
• Contribute to technical documentation, risk management, and regulatory submissions.
• Monitor intellectual property developments and identify opportunities for new patent generation.

Contribute to Company Strategy

• Act as a trusted advisor to leadership on assay feasibility, timelines, risks, and product differentiation.
• Support strategic roadmap and portfolio decisions.

Qualifications & Skills

Technical Expertise

• Deep expertise in molecular diagnostics assay development (e.g. PCR/qPCR, isothermal amplification, nucleic acid detection).
• Strong understanding of assay robustness, variability, and failure modes in real-world use.
• Experience with assay transfer to manufacturing and scale-up.
• Working knowledge of IVD regulatory and quality frameworks.

Leadership & Collaboration

• Proven ability to lead multidisciplinary teams and operate at department-head level.
• Strong cross-functional communication skills, especially with hardware, quality, regulatory, and manufacturing teams.
• Comfortable balancing scientific depth with product-level decision making.

Execution & Judgment

• Excellent prioritization and risk-based decision-making skills.
• Ability to operate effectively in a fast-moving startup environment with evolving constraints.
• Clear communicator to both technical and non-technical stakeholders.

Qualifications

• PhD or MSc in Molecular Biology, Biochemistry, Biotechnology, or a related field (PhD strongly preferred).
• 8–12+ years of experience in assay development for molecular diagnostics or IVD products.
• Demonstrated experience bringing assays from early development through validation and commercialization.
• Prior leadership experience (e.g. team lead, group leader, director level).
• Experience in a regulated medical device or IVD environment is essential; startup or scale-up experience is a strong plus

What we offer

• A competitive and market-aligned compensation package, reflecting your experience, expertise, and leadership responsibilities.
• The opportunity to participate in Rapidemic’s Employee Stock Ownership Plan (ESOP), allowing you to share in the long-term success and value creation of the company.
• A unique opportunity to shape the scientific direction of a pioneering diagnostics company and play a key role in its growth journey.
• A collaborative, low-hierarchy environment where your ideas and contributions have a direct impact on products, strategy, and innovation.
• The chance to work on technologies with the potential to transform healthcare and improve patient outcomes worldwide.

What Success Looks Like

• Product development, verification, validation, and manufacturing readiness are tightly aligned and predictable.
• Risks are identified early and managed proactively.
• Teams are aligned around clear priorities, timelines, and ownership.
• The transition from development into validation and early production feels controlled rather than rushed.
• External commitments are met reliably without distracting from core execution.
• The CEO can focus on strategy and external engagement, confident that execution is well owned.

How to Apply

Interested? Please send your CV and motivation letter (saved as one PDF) to [email removed] with as subject “Head of Assay Development”. Applications through the portal of the Leiden Bioscience Park website are also accepted. Only applications containing a motivation letter will be reviewed.

Only apply if you can start before the 1st of November 2026. Please apply through the platform directly.

We look forward to receiving your applications!