Validation Consultant

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).

Job 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 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 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:

• 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.

Work 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.