Solid Tumor Development Scientist - Phoenix, AZ

Caris Life Sciences•Phoenix, AZ

1d•Onsite

About The Position

The Solid Tumor Scientist works in the Assay Development and Validation Department and contributes to the development, validation, transfer, establishment, troubleshooting, subject-matter-expert support, and launch of molecular assays, instrumentation, studies, and methodologies for solid tumor profiling in the clinical laboratory. This is a combined laboratory and managerial role involving experiment planning and execution, data analysis, technical support, study documentation, and knowledge transfer to team members and partner departments. The position requires independently conducting complex experiments, drawing meaningful conclusions, and communicating effectively across functions. The scientist applies working knowledge of regulated study design, including analytical verification and validation for laboratory-developed tests and, where applicable, in vitro diagnostics. The role collaborates with Assay Development, Molecular Operations, Bioinformatics/Statistics, Quality Assurance, Regulatory Affairs, Translational Science, and other stakeholders. The position regularly involves work at both a computer workstation and laboratory bench. It may require periodic travel, after-hours emergency response, occasional evening, weekend, or holiday work, and periodically scheduled on-call periods.

Requirements

Master’s degree in Molecular Biology, Molecular Genetics, Biochemistry, Oncology, Cancer Biology, or a related life-sciences field and at least 4 years of relevant research, translational, or clinical molecular laboratory experience; or a Ph.D. in one of these fields and 1–3 years of relevant postdoctoral or industry experience. Equivalent combinations of education and relevant industry experience may be considered.
Ability to explain prior molecular assay experience, including positive and negative controls, sample results, and data interpretation.
Working knowledge of regulated study design for molecular assay development and analytical validation, such as accuracy/concordance, precision, limit of detection/sensitivity, limit of blank, specificity, and appropriate controls.
Hands-on molecular biology laboratory skills and ability to work independently on complex laboratory tasks.
Ability to work both at the bench and at a desk, including executing experiments, analyzing data, writing study documents, and presenting results.
Familiarity with nucleic acid extraction from solid tumor specimens and bone marrow, and with NGS and/or targeted molecular methods, including library preparation, sequencing, and interpretation of NGS quality statistics.
Ability to draw meaningful conclusions from multi-condition experiments and summarize data for scientific and operational audiences.
Effective verbal and written communication skills and ability to share and receive information across organizational levels and collaborate constructively with interdisciplinary teams.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook) and general working knowledge of the Internet for business use.
Knowledge of laboratory safety procedures for biohazards and chemicals, as well as quality-control procedures and regulations.

Nice To Haves

Experience contributing to Quality Management System deliverables, risk assessments (FMEA), design reviews, or regulatory submission content such as FDA 510(k), PMA, EUA, or IVDR for NGS-based oncology or companion diagnostic assays.
Experience with solid tumor comprehensive genomic profiling or related oncology NGS panels (DNA and/or RNA), including SNVs/indels, copy-number alterations, fusions/splice variants, MSI, TMB, and/or HRD.
Laboratory automation experience across multiple platforms, such as Beckman, Agilent, Hamilton, Tecan, or SPT, and experience with high-throughput assay development or application.
Experience with multiple NGS platforms and a variety of analysis methods.
Experience drafting or reviewing analytical verification and validation protocols and reports; familiarity with CLSI guideline principles for analytical performance.
Familiarity with Design Control and product development in a regulated IVD or medical-device environment, including FDA 21 CFR Part 820, ISO 13485, IVDR, or equivalent.
Scientific writing experience, including validation documents, protocols, SOPs, and/or peer-reviewed publications.
Knowledge of evolving solid tumor biomarkers, therapeutic targets, and companion-diagnostic regulatory guidance.
Experience transferring methods into a clinical laboratory and training operational staff.
Scientific rigor, including understanding hypothesis development, experimental design, control selection, and data integrity.
A regulated-study mindset and ability to document work for internal quality review and, where applicable, external regulatory scrutiny.
Ability to move effectively between bench execution and written analysis, documentation, and presentation while maintaining quality.
Cross-functional communication skills, including explaining scientific rationale clearly, listening, sharing information, and escalating issues appropriately and promptly.
Drive for results and continuous improvement.
Teamwork and commitment to team and organizational goals in a complex, multifunctional environment.
Strong personal organization, time management, and ability to multitask in a fast-paced, deadline-driven setting.
Learning agility and willingness to take on new challenges and learn proprietary software, platforms, and methods.
Independent judgment within role scope, sound business judgment, and ability to maintain project confidentiality.
Customer-service focus and ability to meet or exceed the needs of internal customers in operations, quality, regulatory, and medical teams.

Responsibilities

Plan, design, and perform laboratory experiments supporting solid tumor assay development, optimization, troubleshooting, and validation.
Execute complex, full-scale experiments with limited supervision, using appropriate multi-condition studies, controls, and sample-selection strategies.
Apply knowledge of solid tumor specimen types and pre-analytical variables, including FFPE tissue, tumor cellularity and necrosis, nucleic acid yield and quality, and sample adequacy.
Perform nucleic acid extraction and molecular methods, including NGS library preparation and related assays; interpret NGS quality metrics and experimental outcomes.
Troubleshoot technical assay issues, recommend and execute verification tests, and discuss experimental options with scientific leads and project teams.
Maintain laboratory equipment and required logs; manage, log, and store reagents, samples, and supplies; create materials and experiment tracking documentation.
Train Molecular Lab Operations Specialists, Molecular Technologists, and PDV Associates on methods when implemented, changed, or otherwise required.
Complete assigned training and competencies in a timely manner.
Contribute to development and analytical verification and validation study design, including scientific rationale, sample requirements, experimental conditions, and acceptance criteria.
Draft, review, and revise experimental plans, validation plans, protocols, reports, SOPs, forms, and other controlled documents.
Analyze average-to-complex datasets, such as NGS quality statistics, concordance, correlation, precision, and comparisons of experimental conditions; develop scientifically sound conclusions and recommendations.
Present experimental results, issues, risks, and proposed next steps within PDV and across Caris as needed.
Follow applicable quality and regulatory requirements, including CAP/CLIA, New York State, MolDx, and internal quality-system expectations.
Translate scientific rationale into clear written and verbal guidance for executing teams and cross-functional partners.
Communicate professionally across PDV and Caris, take ownership of experiments and documents through completion, and support quality, results, and continuous improvement.
Accept other duties as assigned.