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
What You Will Do- 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.
What You'll Need to Have- 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.
- Familiarity with product development processes, design controls, or regulated laboratory environments is preferred.
- 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.
Interview Process
Our interview processes my differ slightly from role-to-role; however, most of our interviews will follow a similar pattern:
- Recruiter Interview
- Hiring Manager interview
- On-site Interview
- Decision
We are an early-stage company and may change our interview process from time-to-time, but our hope is everyone who interviews with us has a positive experience, even if an offer isn't presented.
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
Work - Life Balance Minded Time Off - 15 paid vacation days
- 2-week paid winter break
- 7 company paid holidays
- 5 paid sick days
A Work Culture Which Believes in Promoting from Within - Wear lots of hats / accelerate your career growth!
- We are a flat organization by design - lots of visibility!
- Many of our current leaders started their career with Fluxergy!
Salary Range: $80,000- $100,000/yrAdditional Information
