IVD Assay Characterization & Validation Consultant _CO

Indianapolis, Indiana
October 20, 2026
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Job Description

Job Summary :

  • 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.
  • At client, we are passionate about transforming patients’ lives and we are fearless in both decisions 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 client’s Diagnostics – 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.

Duties & 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 client 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 a Products 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 Product.

Qualifications & Technical Expertise :

  • 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 (client’s 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.

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