Clinical Assay Development Associate Scientist

VitalBio; Temple (TX); On-site; USD 80,000 - 110,000; Full time

Job summary

VitalBio in Texas is seeking a Clinical and Analytical Development Associate to help develop and verify cell-based assays for a new clinical diagnostic analyzer. You will work on a CBC panel with 5-part differential on an automated platform, collaborating with scientists, engineers, and software teams.

The role emphasizes adhering to FDA/CLIA guidelines, maintaining detailed records, troubleshooting, and applying new technologies to improve assay development and integration.

Qualifications

• 2+ years of hands-on experience in clinical chemistry assay development or cell-based assays.
• Experience with PCR/qPCR, ELISA, flow cytometry.
• Experience with regulatory standards (FDA/CLIA) is advantageous.
• Ability to script in Python or R to automate workflows.

Responsibilities

• Support optimization and verification of a CBC panel on automated platform.
• Troubleshoot reagents, consumables, and instrumentation.
• Maintain protocols and results under regulatory standards.
• Collaborate with interdisciplinary teams to integrate assays into workflows.
• Identify and resolve technical challenges to ensure assay performance.
• Maintain quality control measures for assay consistency.
• Stay updated on emerging technologies to enhance development processes.

Skills

PCR

qPCR

ELISA

Flow cytometry

Python scripting

R scripting

Data analysis

MS Word

MS Excel

Regulatory knowledge

Education

Bachelor’s or Master’s degree in Molecular Biology/Biochemistry/Biotechnology/Bioengineering or related field

Tools

Microfluidics

Next-generation sequencing

Automated microscopy systems

Bioanalytical instrumentation

Job description

VitalBio in Texas is seeking a Clinical and Analytical Development Associate to help develop and verify cell-based assays for a new clinical diagnostic analyzer. You will work on a CBC panel with 5-part differential on an automated platform, collaborating with scientists, engineers, and software teams.

The role emphasizes adhering to FDA/CLIA guidelines, maintaining detailed records, troubleshooting, and applying new technologies to improve assay development and integration.