Job Description & Details
This is a hands-on consulting role for an IVD Assay Characterization & Validation expert stepping into a major diagnostics manufacturing facility. You'll be bridging the gap between theoretical biochemistry and commercial scale-up for automated clinical chemistry systems. If you like spending your days knee-deep in CLSI protocols and solving complex matrix phenomena, this project in Indianapolis is worth a close look.
What You'll Actually Be Doing
Expect to spend a good portion of your time designing and executing multi-day evaluations like 20-day EP05 protocols, spike-and-recovery assessments, and defining Limits of Detection and Quantitation. You won't just be sitting behind a desk writing specs; you'll be hands-on operating automated clinical chemistry platforms, troubleshooting fluidic behavior, and figuring out recovery bias in aqueous solutions. When the data is collected, you'll translate those raw datasets into comprehensive Method Validation Reports for Design History Files and help compile packages for FDA Q-Sub interactions.
The Core Tech Stack
You need deep, practical fluency in CLSI guidelines and hands-on operational experience with automated clinical chemistry analyzers—specifically Roche Cobas systems. A strong grasp of FDA 21 CFR 820 and ISO 13485 quality environments is non-negotiable since you'll be writing formal validation protocols and regulatory documentation. Familiarity with specialized validation software to build statistical models and recovery plots will be your bread and butter here.
Interview Expectations
When talking to the hiring manager, expect them to test your practical troubleshooting skills by asking how you would handle an unexpected recovery bias during a multi-day precision study on a Cobas analyzer. They are secretly looking to see if you panic or if you systematically isolate variables like surface tension or interferents. They will also likely drill down into your experience with FDA 510(k) matrix expansion strategies, wanting to hear a concrete example of how you framed technical questions for a Q-Sub interaction without stalling the product timeline.
Application Advice
To get past the ATS, make sure your resume explicitly features keywords like CLSI guidelines, EP05 protocols, method validation, Design History File, and specific analyzer platforms like Cobas. Don't just list these terms in a skills section; weave them into your work history by describing past projects where you authored validation protocols and dealt with FDA regulatory filings. Highlight your Ph.D. background or relevant biomedical engineering experience right at the top so recruiters immediately see your technical depth.