Director of Immunoassay Development
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Job Location:
Irvine, CA - USA
Monthly Salary:
$ 170000 - 195000
Posted on:
20 days ago
Vacancies:
1 Vacancy
Job Summary
About Us
Fluxergy is a rapidly growing in vitro diagnostics company innovating on the cutting-edge of laboratory testing. Were 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 companys 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.
Our product: 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. Youll guide both the strategic vision and technical execution across the full product lifecyclefrom 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
- 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 Youll 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.
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 isnt presented.
Benefits
Excellent Medical/Dental Benefits
- 99% 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: $170000- $195000/yr
Additional Information
Fluxergy is an equal opportunity employer. We do not discriminate on the basis of race color religion sex sexual orientation gender identity marital status age disability national or ethnic origin military service status citizenship or other protected characteristic.
We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.
Required Experience:
Director
Key Skills
- Crisis Management
- Marketing
- Public Relations
- Fundraising
- Media Relations
- Constant Contact
- Strategic Planning
- Social Media Management
- Team Management
- Public Speaking
- Wordpress
- Writing Skills
About Company
Fluxergy is the first open platform for multimodal, point-of-care assay development and testing.
