Translational Scientist – LDT
Caris Life Sciences
full-time
Posted on:
Location Type: Hybrid
Location: Tempe • Arizona • United States
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About the role
- Composes scientific and technical documents throughout the product development process through collaboration with cross-functional teams including Product Development, Bioinformatics/Statisticians, Molecular Operations, QA, and RA.
- Support validation studies for LDT assays: Contribute to study design and sample planning.
- Draft and review validation plans and reports.
- Ensure scientific rigor in data interpretation for analytical performance metrics (e.g., LoD, specificity, precision).
- Translate complex scientific rationale into clear guidance for execution teams.
- Participate in cross-functional risk assessments (e.g., FMEA), design reviews and contribute to design control deliverables including design inputs, outputs and traceability.
- Extract, synthesize, and format study results for inclusion in validation reports documents.
- Ensure compliance with applicable regulations including CAP/CLIA, ISO15189, ISO 22367 and state-specific requirements.
- Stay up to date with evolving biomarkers, therapeutic targets, and regulatory guidance relevant to oncology diagnostics and LDTs.
- Periodically support validation studies for IVD as needed.
Requirements
- MS or PhD in molecular biology, biochemistry, pharmacology, or equivalent subject matter or a minimum of 5 years relevant professional experience.
- Excellent oral and written communication skills.
- Strong scientific writing experience (e.g., validation documents, protocols, SOPs, peer-reviewed publications).
- Solid understanding of molecular biology principles and assay development processes.
- Familiarity with CAP/CLIA product development.
- Ability to work effectively across interdisciplinary teams and manage multiple priorities.
- Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working.
- Knowledge of Internet for business use.
- Must be tolerant to change, ready to take on new challenges and open to learning new skills.
Benefits
- Training all job specific, safety, and compliance training are assigned based on the job functions associated with this employee.
- Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check (applicable for certain positions) and reference verification.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
scientific writingassay developmentdata interpretationvalidation studiesstudy designsample planningdesign controlrisk assessmentsanalytical performance metricsmolecular biology principles
Soft Skills
oral communicationwritten communicationcollaborationinterdisciplinary teamworkprioritizationadaptabilityproblem-solvingattention to detailcritical thinkingopen to learning
Certifications
MS in molecular biologyPhD in molecular biologyCAP/CLIA complianceISO15189 complianceISO 22367 compliance