IVD Assay Characterization & Validation Consultant _CO

BEPC Inc. - Business Excellence Professional Consulting; Indianapolis (IN); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

ESOP

Job summary

BEPC Inc. in Indianapolis, Indiana seeks an experienced IVD Assay Scientist to support development, characterization, and validation of automated clinical chemistry assays.

You will lead analytical verification studies, develop validation protocols, and prepare technical documentation for regulatory submissions. This role offers collaboration with multidisciplinary teams across science, engineering, and regulatory, with hands‑on bench work and instrument operation.

Qualifications

• Bachelor’s degree in Clinical Chemistry, Biochemistry, Biomedical Engineering, or related scientific discipline.
• Minimum of 2 years in IVD assay development, characterization, analytical verification, or method validation.
• Hands‑on experience developing analytical validation protocols following CLSI guidelines.
• Experience with automated clinical chemistry analyzers in a laboratory environment.
• Knowledge of analytical performance testing (precision, linearity, interference, recovery, method comparison).
• Experience in FDA‑regulated or ISO 13485 quality environments.
• Strong analytical troubleshooting and data integrity focus.
• Excellent written and verbal communication across teams.

Responsibilities

• Develop, review, and execute analytical validation protocols per CLSI guidelines.
• Establish acceptance criteria for standard, modified, and synthetic matrices.
• Design experiments for precision, linearity, interference, stability, and performance.
• Conduct method verification/validation for diagnostic assay development and manufacturing.
• Operate, calibrate, troubleshoot, and maintain Roche Cobas analyzers.
• Perform 20‑day precision evaluations, spike/recovery testing, and serial dilutions.
• Train staff on SOPs, instrumentation, and testing methods.
• Prepare Method Validation Reports and maintain DHF documentation.
• Collaborate with regulatory teams to address FDA questions.

Skills

CLSI guidelines

Analytical validation

IVD assay development

Regulatory documentation

Data analysis

Communication

Education

Bachelor’s degree in Clinical Chemistry/Biochemistry or related

Master’s or PhD preferred

PhD candidates considered

Tools

Roche Cobas

Job description

Location: Indianapolis, IN (Hybrid – 3 Days Onsite / 2 Days Remote, Depending on Job Duties)

Employment Type: Full-Time, 12-Month W2 Contract

Pay Rate: Compensation details will be provided during the recruitment process.

--- This is a W2 Contract only role --- C2C / B2B will not be considered.

Role Overview

BEPC Inc. is seeking an experienced IVD Assay Scientist to support our client's development, characterization, and validation of automated clinical chemistry assays in Indianapolis, IN.

This is an exciting opportunity for a hands‑on scientist with expertise in in vitro diagnostics (IVD), CLSI validation protocols, automated clinical chemistry analyzers, and FDA regulatory documentation.

The ideal candidate will have experience translating complex biochemical assays into reliable, scalable diagnostic products. You will lead analytical verification studies, develop validation protocols, investigate assay performance, and prepare technical documentation supporting regulatory submissions.

This position offers the opportunity to contribute to innovative diagnostic technologies that help improve patient care while collaborating with multidisciplinary scientific, engineering, and regulatory teams.

Key Responsibilities

Assay Development & CLSI Validation

• Develop, review, and execute analytical validation protocols in accordance with Clinical and Laboratory Standards Institute (CLSI) guidelines.
• Establish analytical and clinical acceptance criteria for standard, modified, and synthetic sample matrices.
• Design experiments to evaluate assay precision, linearity, interference, stability, and analytical performance.
• Conduct method verification and validation studies supporting diagnostic assay development and manufacturing.

Laboratory Testing & Analyzer Operations

• Operate, calibrate, troubleshoot, and maintain automated clinical chemistry analyzers, including Roche Cobas platforms.
• Perform complex analytical studies, including 20-day precision evaluations (CLSI EP05), spike-and-recovery testing, and serial dilution experiments.
• Execute laboratory testing protocols while maintaining accurate records and ensuring data integrity.
• Train laboratory personnel on standard operating procedures (SOPs), instrumentation, and analytical testing methods.

Assay Characterization & Method Comparison

• Conduct method comparison studies to evaluate candidate assays against established reference methods and standards.
• Investigate matrix effects, recovery bias, surface tension variations, and fluidic behavior in protein‑free aqueous solutions.
• Determine analytical performance characteristics, including Limits of Detection (LoD), Limits of Quantitation (LoQ), and Analytical Measuring Ranges (AMR).
• Identify assay performance issues and develop scientifically sound solutions to improve accuracy, reliability, and reproducibility.

Data Analysis & Regulatory Documentation

• Analyze experimental data using statistical software to evaluate precision, recovery, bias, and method performance.
• Prepare comprehensive Method Validation Reports (MVRs) and supporting technical documentation.
• Maintain validation records for inclusion in Design History Files (DHF) and regulatory submissions.
• Develop analytical performance documentation supporting FDA Pre‑Submission (Q‑Sub) activities.
• Collaborate with regulatory and technical teams to address FDA questions related to assay validation, matrix expansion, and analytical performance.

Qualifications

Required Qualifications

• Education: Bachelor’s, Master’s, or Ph.D. degree (including Ph.D. candidates) in Clinical Chemistry, Biochemistry, Biomedical Engineering, or a related scientific discipline.
• Experience: Minimum of 2 years of professional experience in IVD assay development, characterization, analytical verification, or method validation.
• Hands‑on experience developing and executing analytical validation protocols following CLSI guidelines.
• Experience working with automated clinical chemistry analyzers in a laboratory environment.
• Knowledge of analytical performance testing, including precision, linearity, interference, recovery, and method comparison.
• Experience working in an FDA‑regulated or ISO 13485 quality environment.
• Strong analytical troubleshooting skills and the ability to investigate complex assay performance challenges.
• Experience analyzing experimental data and preparing technical reports.
• Excellent written and verbal communication skills, with the ability to collaborate across scientific, engineering, and regulatory teams.

Preferred Qualifications

• Direct experience operating Roche Cobas clinical chemistry analyzers.
• Experience performing CLSI EP05 precision studies and other standardized analytical validation protocols.
• Familiarity with FDA 510(k) submissions, matrix expansion strategies, and the FDA Q‑Submission process.
• Experience preparing Method Validation Reports (MVRs), Design History File (DHF) documentation, or regulatory submission packages.
• Knowledge of assay matrix effects, analytical recovery, fluidic behavior, and biochemical assay optimization.
• Experience using statistical analysis or specialized method validation software.
• Previous experience supporting the transition of diagnostic assays from research and development into commercial manufacturing.

Ideal Candidate

We are looking for a detail‑oriented, self‑motivated scientist who:

• Enjoys hands‑on laboratory work and solving complex analytical challenges.
• Understands the relationship between assay chemistry, instrumentation, and diagnostic product performance.
• Can independently design experiments, interpret results, and recommend technical solutions.
• Demonstrates strong scientific judgment, attention to detail, and commitment to data integrity.
• Communicates effectively with laboratory scientists, engineers, quality professionals, and regulatory specialists.
• Thrives in a collaborative, fast‑paced product development environment.
• Contract Duration: 12 Months
• Employment Classification: W2 Contract
• Work Location: Indianapolis, Indiana
• Work Arrangement: Hybrid – Approximately 3 Days Onsite and 2 Days Remote, Depending on Job Responsibilities
• End Date: 12 Months
• Benefits: Medical, Dental, Vision, and Life Insurance

This position requires hands‑on laboratory testing and instrument operation. Onsite attendance may vary depending on experimental schedules and project requirements.

About BEPC

BEPC Inc., founded in 2007, is a 100% employee‑owned company providing top‑tier consulting and staffing solutions across industries such as technology, engineering, manufacturing, and project management.

At BEPC, we are driven by innovation and a commitment to excellence. We take pride in fostering a collaborative and innovative environment where our team members thrive.

As an employee‑owned organization through our Employee Stock Ownership Program (ESOP), we believe in building lasting relationships and creating meaningful career opportunities.

With competitive benefits, including medical, dental, vision, and life insurance, BEPC is dedicated to supporting our employees' personal and professional growth.

Join BEPC and contribute your expertise to projects that advance innovation and make a meaningful impact.