Assay Characterization & Validation Consultant

Job Title:

Assay Characterization & Validation Consultant

Location:

Indianapolis, IN (Hybrid: 3 days onsite, 2 days remote based on job duties) Duration:
Contract - 12 months Job  About BCforward BCforward is a leading global IT consulting and workforce solutions firm providing services and support to Fortune 500 and government clients. Founded in 1998, BCforward has grown with our customers needs into a full-service business solutions provider. With delivery centers and offices across North America and India, we take pride in building long-term relationships and delivering excellence through innovation, collaboration, and integrity.

Job Description We are seeking an IVD Assay Characterization & Validation Consultant to drive technical characterization, execution, analytical verification, and regulatory documentation for automated clinical chemistry assays. The role requires a hands-on scientist with a track record of translating complex biochemical assays into scalable diagnostic products. The consultant will lead CLSI-compliant validation protocols, manage analyzer operations, conduct 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 think less about their daily routine through a portfolio that spans blood glucose monitoring, information management, and continuous glucose monitoring. We aim to deliver innovative products, services, and comprehensive solutions for convenient, efficient, and effective diabetes management. We are committed to a diverse and inclusive workplace and to scientific rigor, ethics, and access to medical innovations.

Internal Manufacturing Indianapolis, within Diagnostics - Near Patient Care Operations, is responsible for strip manufacturing for the blood glucose monitoring portfolio and will expand to sensor manufacturing for continuous glucose monitoring. Responsibilities:
Experimental Design & CLSI Protocol Development:
Author, review, and finalize clinical validation protocols aligned with CLSI guidelines. Establish analytical and clinical acceptance criteria for non-standard, altered, or synthetic matrices. Design iterative studies for precision, linearity, interferents, stability, and matrix dynamics. Analyzer Operations & Bench Execution:
Lead operation, calibration, and execution on automated clinical chemistry platforms, with emphasis on Cobas systems. Perform multi-day evaluations such as 20-day EP05 protocols, spike-and-recovery assessments, and serial dilutions. Mentor and train staff on SOPs and analytical techniques. Assay Characterization & Method Comparison:
Lead method comparison studies against primary and secondary reference standards. Investigate matrix phenomena, surface tension, fluidic behavior, and recovery bias in protein-free aqueous solutions. Define LoD, LoQ, and AMR through iterative characterization cycles. Data Analysis & Regulatory Documentation:
Perform statistical analysis using validation software to generate models, recovery plots, and bias metrics. Draft Method Validation Reports for the Design History File and regulatory use. Compile analytical performance packages and frame questions for FDA Q-Sub interactions. Required Skills &

Qualifications:

Education:

B.S., M.S., On-going Ph.D, or Ph.D. in Clinical Chemistry, Biochemistry, Biomedical Engineering, or related field. Industry

Experience:

2+ years in IVD assay development, characterization, and method validation within a regulated environment (FDA 21 CFR 820 / ISO 13485). CLSI Fluency:
Practical knowledge of CLSI standard methodologies and study designs. Instrumentation:
Hands-on experience with automated…