Translational Scientist
Caris Life Sciences
full-time
Posted on:
Location Type: Hybrid
Location: Tempe • Arizona • Texas • United States
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Salary
💰 $110,000 - $130,000 per year
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 analytical verification and validation (V&V) studies for oncology-focused IVD assays: Contribute to study design and sample planning.
- Draft and review V&V protocols 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.
- Collaborate with Regulatory Affairs to prepare and review regulatory submissions (e.g., FDA 510(k), PMA, EUA, IVDR), including pre- and post-market documents.
- Extract, synthesize, and format study results for inclusion in regulatory submission documents.
- Ensure compliance with applicable regulations including FDA 21 CFR Part 820, ISO 13485, IVDR, and country-specific requirements.
- Stay up to date with evolving oncology biomarkers, therapeutic targets, and regulatory guidance relevant to oncology diagnostics and companion diagnostics (CDx).
Requirements
- MS degree in Molecular Biology, Biochemistry, Pharmacology, or a related life sciences field with 5+ years of relevant industry experience; or a PhD with relevant training and experience.
- 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 Design Control and product development within a regulated (IVD or medical device) environment.
- 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.
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
scientific writinganalytical verificationvalidation studiesassay developmentdata interpretationrisk assessmentsdesign controlregulatory submissionsmolecular biologybiochemistry
Soft Skills
collaborationcommunicationinterdisciplinary teamworkprioritizationproblem-solving