Director of Immunoassay Development

What You Will Do

• Lead the full immunoassay development lifecycle from early concept and feasibility to design transfer, verification, validation, and regulatory submission.
• Transform scientific innovation into impact by translating early proof-of-concept studies into structured design inputs, specifications, and controlled development plans aligned with FDA, ISO 13485, and CE-IVD requirements.
• Design and oversee meaningful experiments that generate high-quality data for regulatory submissions, ensuring traceability and alignment between design inputs, verification, and validation outcomes.
• Collaborate seamlessly with Regulatory Affairs and Quality teams to ensure experimental design, documentation, and testing strategies meet FDA 21 CFR 820 and IVDR standards.
• Partner cross-functionally with Manufacturing, Process Engineering, and Operations to refine assay transfer protocols that drive robustness, scalability, and cost-effectiveness in production.
• Oversee design verification and validation (V&V) activities including method comparison, reproducibility, precision, interference, and stability studies — ensuring data integrity and regulatory readiness.
• Drive design transfer to manufacturing, supporting process qualification, equipment validation, and training to enable smooth transition into production.
• Mentor and empower a multidisciplinary team of scientists and engineers, fostering a culture rooted in collaboration, scientific rigor, and continuous learning.
• Work strategically with Program Management to define project timelines, resource plans, and risk mitigation strategies that align with company milestones and product launch goals.
• Review and approve technical documentation, design history files, verification reports, and regulatory submissions (e.g., 510(k), De Novo, CE-IVD) with a commitment to excellence and compliance.
• Stay future-focused by keeping current with evolving FDA and IVDR guidance, and by evaluating emerging immunoassay technologies that strengthen innovation and competitiveness.

What You'll Need to Have

• Ph.D. in Biochemistry, Immunology, Analytical Chemistry, or related discipline with a strong foundation in immunoassay principles.
• 10+ years of industry experience in immunoassay or in vitro diagnostic (IVD) product development within a regulated design control environment.
• Proven track record of translating benchtop assays (e.g., ELISA, CLIA, LFA, bead-based, or homogeneous immunoassays) into validated, manufacturable diagnostic products.
• Comprehensive understanding of FDA 21 CFR 820, ISO 13485, IVDR, and design control processes — including risk management, verification, validation, and design transfer.
• Demonstrated success in verification and validation planning, data analysis, and preparation of high-quality data packages for regulatory submissions.
• Hands-on collaboration experience with manufacturing and process engineering teams to scale production and ensure consistency across lots.
• Inclusive and results-oriented leadership style, with the ability to guide teams, balance priorities, and deliver products that meet technical and regulatory milestones.
• Excellent communication and collaboration skills, with the ability to connect scientific, regulatory, and business goals across diverse teams and stakeholders.