R&D Scientist, Immunoassay Development

Fluxergy • Irvine, CA

3d

About The Position

Fluxergy is a rapidly growing in vitro diagnostics company innovating on the cutting-edge of laboratory testing. We’re developing the first and only multi-modal point-of-care platform that enables molecular, clinical chemistry, immunoassay, and hematology testing on the same system. Our platform spans many markets including the clinical, veterinary, and food safety industries. We are seeking self-motivated problem solvers who are excited to help decentralize traditional laboratory infrastructure. At the core of our company’s identity is a strong foundation in engineering. We take great pride in our commitment to critical thinking and pragmatic problem-solving through a modular and systemic perspective. We hold the conviction that transparent communication, coupled with the flexibility to adjust to evolving scenarios and the willingness to venture beyond familiar territories, is crucial to both our success and yours.

About the Role As the Director of Immunoassay Development, you will lead the transformation of innovative assay concepts into robust, scalable, and regulatory-compliant diagnostic products that advance patient care. You’ll guide both the strategic vision and technical execution across the full product lifecycle—from early feasibility through design control, verification, validation, and seamless transfer to manufacturing. This role is ideal for a dynamic, hands-on leader who combines deep immunoassay expertise with a passion for mentoring teams, driving cross-functional collaboration, and shaping the future of diagnostic innovation.

Team Culture: - Research Oriented - Problem Solvers - Detail Oriented - Analytical - Collaborative

Requirements

• M.S. or Ph.D. in Biochemistry, Immunology, Molecular Biology, Biomedical Engineering, Analytical Chemistry, or a related scientific discipline.
• 3+ years of industry or advanced research experience developing and optimizing biological assays in a laboratory setting.
• Strong hands-on experience with immunoassay techniques such as ELISA, bead-based assays, FRET, CLIA, lateral flow assays, or related technologies.
• Demonstrated experience designing and analyzing experiments using DOE methodologies and statistical tools.
• Strong experimental troubleshooting skills and the ability to independently plan and execute laboratory studies.
• Experience analyzing complex datasets and translating findings into actionable recommendations.
• Excellent written and verbal communication skills, including the ability to clearly present technical findings to diverse audiences.
• Collaborative mindset with a passion for scientific discovery, continuous learning, and solving real-world problems.

Nice To Haves

• Familiarity with product development processes, design controls, or regulated laboratory environments is preferred.

Responsibilities

• Design, execute, and analyze immunoassay experiments to support product development, optimization, and verification activities.
• Apply Design of Experiments (DOE) methodologies to efficiently evaluate assay performance, identify critical variables, and drive data-based decision-making.
• Develop and optimize immunoassays, including reagent selection, assay conditions, performance characterization, and troubleshooting.
• Generate high-quality experimental data and maintain accurate documentation in accordance with quality and design control requirements.
• Collaborate with scientists, engineers, and cross-functional teams to investigate technical challenges and implement effective solutions.
• Perform assay verification studies, including precision, reproducibility, sensitivity, specificity, interference, and stability assessments.
• Analyze experimental results using statistical tools and communicate findings through technical reports, presentations, and team discussions.
• Support technology transfer activities by partnering with Manufacturing and Process Development teams to improve assay robustness and scalability.
• Contribute to risk assessments, design documentation, and development activities that support regulatory submissions and product commercialization.
• Stay informed of emerging immunoassay technologies, scientific literature, and industry best practices to drive continuous innovation.

Benefits

• Excellent Medical/Dental Benefits - 95% medical benefit premiums paid by Fluxergy and covers employee, partner, and dependents
• 100% dental and vision premiums paid for employee, partner, and dependents
• 100% Life Insurance premiums paid for the employee
• 15 paid vacation days
• 2-week paid winter break
• 7 company paid holidays
• 5 paid sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Director