US_IVD Assay Characterization & Validation Consultant _CO

Job Title: US_IVD Assay Characterization & Validation Consultant _CO

Location: Indianapolis, IN (Hybrid: 3 days onsite, 2 days remote, depending on job duties)

Duration: Contract - 12 months

Job ID: 411089

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 experience translating complex biochemical assays into scalable, manufactured diagnostic products, leading CLSI-compliant validation protocols, managing analyzer operations, performing multi-method matrix characterizations, and authoring 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 so they can gain relief day and night. We offer a portfolio of solutions for people with diabetes and their professionals, from blood glucose monitoring to information management to continuous glucose monitoring. We aim to offer innovative products, services, and comprehensive solutions for convenient, efficient, and effective diabetes management. We are committed to a diverse and inclusive workplace and to building teams that represent a range of backgrounds, perspectives, and skills. At Roche, we commit to scientific rigor, unassailable ethics, and access to medical innovations for all, to build a better tomorrow. Internal Manufacturing Indianapolis within Roche Diagnostics - Near Patient Care Operations is responsible for strip manufacturing for our blood glucose monitoring portfolio and will expand to sensor manufacturing for our continuous glucose monitoring portfolio.

Responsibilities:

• Design and author CLSI-aligned clinical validation protocols and establish analytical and clinical acceptance criteria for non-standard, altered, or synthetic matrices.


• Plan and execute iterative experimental workflows to characterize precision, linearity, interferents, stability, and matrix dynamics.


• Lead operation, calibration, and execution on automated clinical chemistry platforms, with emphasis on Roche Cobas systems.


• Perform multi-day evaluations such as EP05 20-day studies, spike-and-recovery assessments, and serial dilution series.


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


• Lead method comparison studies against primary and secondary reference standards and investigate matrix effects and recovery bias.


• Define LoD, LoQ, and AMR through iterative assay characterization cycles.


• Analyze datasets using validation software to generate statistical models, recovery plots, and bias metrics.


• Draft Method Validation Reports for DHF inclusion and regulatory filings.


• Compile analytical performance packages for FDA Q-Sub and frame technical and regulatory questions for matrix expansion and validation scope.

Required Skills & Qualifications:

• B.S., M.S., on-going Ph.D, or Ph.D. in Clinical Chemistry, Biochemistry, Biomedical Engineering, or related discipline.


• 2+ years in IVD assay development, characterization, and method validation within FDA 21 CFR 820 or ISO 13485 environments.


• Practical fluency with CLSI standard methodologies and validation protocols.


• Hands-on operation of automated clinical chemistry analyzers, preferably Roche Cobas.


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

Preferred Skills:

• Experience with method comparison to reference standards and management of matrix-related phenomena.


• Proficiency with statistical validation software and data visualization for assay performance assessment.

Why BCforward?

At BCforward, we believe in advancing lives and careers. When you join our team, you gain access to:

• Competitive compensation and benefits


• Opportunities for growth with global clients


• A supportive, inclusive culture that values innovation and people


• Exposure to cutting-edge technologies and projects

What We Offer

• Flexible consulting or contract arrangement


• Competitive hourly or project-based compensation


• Direct contribution to a commercial point-of-care IVD product launch


• Potential for expanded technical leadership or long-term collaboration

About Our Commitment

BCforward is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, or veteran status.

Interested? Apply Now!

If this sounds like the right opportunity for you, please apply with your most recent resume.