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).
Must be tolerant to change, ready to take on new challenges and open to learning new skills.

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.
Hands-on or scientific knowledge of Next-Generation Sequencing (NGS) platforms and applications (preferred).
Experience working within Quality Management Systems (QMS) aligned with ISO 13485, FDA QSR, or IVDR (preferred).
Experience with IVD or SaMD product development and regulatory submissions (510(k), PMA, IVDR, etc.) (preferred).
Familiarity with analytical validation principles including standards (e.g., CLSI guidelines) (preferred).

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.
Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Translational Scientist

Key skills