IVD Assay Scientist: Validation & Characterization (Hybrid)

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

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.