IVD Assay Characterization & Validation Consultant

Position Overview We are seeking an IVD Assay Characterization & Validation Consultant to drive the technical characterization, execution, analytical verification, and regulatory documentation for automated clinical chemistry assays. This role requires a hands-on scientist with a proven track record of translating complex biochemical assays into scalable, manufactured diagnostic products. You will spearhead CLSI-compliant validation protocols, manage analyzer operations, lead multi-method matrix characterizations, and author technical packages for FDA Pre-Submissions (Q-Sub).

Organization Overview Doing now what patients need next. Near Patient Care is committed to helping people with diabetes everywhere in the world think less about their daily diabetes routine, so they can get true relief, day and night. We offer a broad portfolio of solutions for both people with diabetes and their professionals - from blood glucose monitoring to information management to continuous glucose monitoring. Our aim is to offer innovative products, services and comprehensive solutions for convenient, efficient and effective diabetes management.

We are strongly committed to a diverse and inclusive workplace. We strive to build teams that represent a range of backgrounds, perspectives, and skills. Embracing diversity enables us to create a great place to work and to innovate for patients.

We are passionate about transforming patients lives and we are fearless in both decision and action - we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow.

Internal Manufacturing Indianapolis is a function within the company - Near Patient Care Operations, responsible for the strip manufacturing of the majority of our blood glucose monitoring portfolio for the global demand of our patients. In the future, Internal Manufacturing Indianapolis will also be responsible for sensor manufacturing for our continuous glucose monitoring portfolio.

Key Responsibilities

Experimental Design & CLSI Protocol Development

Author, review, and finalize formal clinical validation protocols in strict alignment with CLSI guidelines.

Establish analytical and clinical acceptance criteria for non-standard, altered, or synthetic matrix applications.

Design iterative experimental workflows to characterize precision, linearity, interferents, stability, and matrix dynamics.

Analyzer Operations & Bench Execution

Lead hands-on operation, calibration, and execution on automated clinical chemistry platforms (specifically Roche Cobas systems).

Perform complex multi-day evaluations (e.g., 20-day EP05 protocols), spike-and-recovery assessments, and serial dilution series.

Mentor and train laboratory staff on platform SOPs, clinical protocols, and standardized analytical techniques.

Assay Characterization & Method Comparison

Spearhead method comparison studies evaluating candidate assays against primary and secondary reference standards

Investigate and resolve complex matrix phenomena, surface tension variations, fluidic behavior, and recovery bias in protein-free aqueous solutions.

Conduct iterative assay characterization cycles to define Limits of Detection/Quantitation (LoD/LoQ) and Analytical Measuring Ranges (AMR).

Data Analysis & Regulatory Documentation

Perform statistical analysis on raw datasets using specialized validation software to build statistical models, recovery plots, and bias metrics.

Draft comprehensive Method Validation Reports (MVRs) for inclusion in the Design History File (DHF) and regulatory filings.

Compile analytical performance packages for FDA Pre-Submission (Q-Sub) documentation.

Frame strategic technical and regulatory questions for FDA Q-Sub interactions regarding matrix expansion and validation scope.

Qualifications & Technical Expertise Education: B.S., M.S., On-going Ph.D or Ph.D. in Clinical Chemistry, Biochemistry, Biomedical Engineering, or a related discipline.

Industry Experience: 2+ years in IVD assay development, characterization, and method validation within a regulated quality environment (FDA 21 CFR 820 / ISO 13485).

CLSI Fluency: Deep, practical knowledge of CLSI standard methodologies.

Instrumentation: Direct, hands-on experience operating automated clinical chemistry analyzers (Cobas experience strongly preferred).

Regulatory Familiarity: Working knowledge of FDA 510(k) matrix expansion strategies and the Q-Sub process.

Ideal Candidate Profile & Key Competencies

Translational Mindset: Demonstrated ability to bridge theoretical chemistry and commercial IVD manufacturing requirements.

Analytical Problem-Solver: Strong, practical troubleshooting capability on benchtop and automated platforms.

Scientific Rigor: Exceptional experimental discipline, data integrity, and attention to detail.

Cross-Functional Communicator: Ability to distill complex analytical findings into actionable insights for scientific, engineering, and regulatory teams.

Autonomy: Self-directed operator who thrives in a fast-paced, milestone-driven product development environment.

What we offer

Flexible consulting/contract arrangement.

Competitive hourly or project-based compensation.

Direct contribution to a large scale commercial point-of-care (POC) IVD product launch.

Potential for expanded technical leadership or long-term collaboration.