Research And Development Scientist

Ospri BioPath; Bartlett (TN); On-site; USD 70,000 - 100,000; Full time

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.

Skills

Technical writing

Detail-oriented

Cross-functional

Independent worker

Data analysis

Education

Bachelor's or Master's in Life Science

Job description

We are seeking a detail-oriented Validation Scientist to design, execute, and document validation and verification studies for laboratory assays and instrumentation. The successful candidate will ensure that test methods perform reliably, meet regulatory and quality requirements, and are ready for routine use. Experience with molecular assays (e.g., PCR, qPCR, dPCR) is strongly preferred, though candidates with strong general assay validation experience are encouraged to apply.

Key Responsibilities

• Plan, execute, and document method validation and verification studies in accordance with applicable regulatory and quality standards.
• Author and review validation protocols, test plans, reports, and standard operating procedures (SOPs).
• Analyze validation data, interpret results, and present clear conclusions with supporting statistics.
• Troubleshoot assay and instrument performance issues and recommend corrective actions.
• Support technology transfer of new or modified assays from development into routine use.
• Maintain accurate, audit-ready documentation and records.
• Collaborate with R&D, quality control, and production teams to meet project timelines.

Required Qualifications

• Bachelor's or Master's degree in a life science discipline (Molecular Biology, Biochemistry, Microbiology, Biotechnology, Chemistry, or a related field).
• Hands-on experience with validation and verification testing of laboratory assays or instruments.
• Working knowledge of assay performance parameters and the statistics used to evaluate them.
• Strong technical writing skills for protocols, reports, and SOPs.
• Solid attention to detail, documentation discipline, and organizational skills.
• Ability to work independently and as part of a cross-functional team.

Preferred Qualifications

• Experience validating molecular assays (PCR, real-time/qPCR, next-generation sequencing, or similar).
• Familiarity with regulated laboratory environments (CLIA, ISO 13485, GLP/GMP, or FDA/IVD).
• Experience with data analysis and statistical tools.
• Understanding of quality management systems, deviations, and change control.
• Analytical and problem-solving mindset.
• Clear written and verbal communication.
• Ability to manage multiple projects and meet deadlines.
• Commitment to quality, accuracy, and continuous improvement.