Validation Scientist – Molecular Assays & Methods

Ospri BioPath

Bartlett (TN)

On-site

USD 70,000 - 100,000

Full time

7 days ago

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Job summary

Ospri BioPath in Bartlett, TN seeks a detail-oriented Validation Scientist to design, execute, and document validation and verification studies for laboratory assays and instrumentation. The role ensures tests perform reliably and meet regulatory and quality standards for routine use.

Experience with molecular assays (PCR, qPCR, dPCR) is strongly preferred, with strong technical writing, data analysis, and collaboration across R&D, quality control, and production to support transfers and

Qualifications

Hands-on validation and verification testing of laboratory assays or instruments.
Knowledge of assay performance parameters and statistics used to evaluate them.
Strong technical writing for protocols, reports, and SOPs.
Excellent attention to detail and organizational skills.
Ability to work independently and in cross-functional teams.

Responsibilities

Plan, execute, and document validation and verification studies.
Author and review validation protocols, test plans, reports, and SOPs.
Analyze validation data, interpret results, and present conclusions with statistics.
Troubleshoot assay and instrument performance issues and propose corrective actions.
Support technology transfer of new or modified assays into routine use.
Maintain audit-ready documentation and records.
Collaborate with R&D, quality control, and production to meet timelines.