Director of Immunoassay Development at Fluxergy

Irvine, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

In Vitro Diagnostics, Healthcare, Clinical Diagnostics, Veterinary, Food SafetyIndustries

Requirements

Ph.D. in Biochemistry, Immunology, Analytical Chemistry, or related discipline with a strong foundation in immunoassay principles
10+ years of industry experience

Responsibilities

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

Skills

Immunoassay Development

Assay Design

Design Control

Verification

Validation

Regulatory Submission

Product Lifecycle Management

Feasibility Studies

Manufacturing Transfer

Cross-Functional Collaboration

Team Leadership

Diagnostic Products

Fluxergy

Portable diagnostic platform for rapid testing

About Fluxergy

Fluxergy offers rapid and accurate laboratory testing solutions through a portable diagnostic platform that can perform multiple tests on-site, which is crucial for Point of Care (PoC) settings. The platform serves various sectors, including healthcare, veterinary medicine, and food safety, with specialized applications for each. Revenue is generated by selling diagnostic devices and test kits directly to clients, and the company is expanding its manufacturing capabilities to meet growing demand. Fluxergy aims to set new standards in laboratory testing by continuously improving its technology.

Irvine, CaliforniaHeadquarters

2011Year Founded

$48.2MTotal Funding

SERIES_CCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Paid Vacation

Paid Sick Leave

Paid Holidays

Risks

Emerging biotech startups increase competition in point-of-care diagnostics.

Regulatory scrutiny may delay product approvals for Fluxergy.

Supply chain issues could impact production of diagnostic devices.

Differentiation

Fluxergy offers a portable platform for rapid, on-site diagnostic testing.

The company serves diverse sectors, including healthcare, veterinary, and food safety.

Fluxergy's COVID-19 testing platform delivers results in under one hour.

Upsides

Growing demand for point-of-care testing boosts Fluxergy's market potential.

Veterinary diagnostics market growth offers opportunities for Fluxergy's products.

Collaborations with institutions enhance Fluxergy's technology validation and reach.

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