Solid Tumor Development Scientist - Phoenix, AZ

Caris Life Sciences•Phoenix, AZ

3d•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 and interpretation, technical support, documentation, presentations, and knowledge transfer to team members and partner departments. The role requires independently executing complex experiments, drawing meaningful conclusions, and communicating across functions. The scientist applies working knowledge of regulated study design, including analytical verification and validation for laboratory-developed tests and, as applicable, in vitro diagnostics, while working with Assay Development, Molecular Operations, Bioinformatics/Statistics, Quality Assurance, Regulatory Affairs, Translational Science, and other stakeholders. The position may require periodic travel, after-hours response to emergency issues, 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 or a related life-sciences 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 the function of 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 laboratory bench and at a desk, including conducting 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, including sharing and receiving information across organizational levels and working 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.
Ability to distinguish fine visual details and pass a visual color discrimination test.
Manual dexterity to use common laboratory equipment and perform sterile techniques as required.
Ability to sit and/or stand for long periods and perform repetitive motion.
Successful completion of the pre-employment process, including criminal background check, drug screening, credit check where applicable, and reference verification.

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 range 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, such as 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, including designing and documenting work to meet 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.
Ability to communicate complex scientific rationale clearly to bench teams, quality and regulatory partners, and leadership; listen, share information, and escalate issues appropriately and in a timely manner.
Drive for results and continuous improvement.
Commitment to team and organizational goals and constructive work in a complex, multifunctional environment.
Strong organization and time management, with ability to multitask in a fast-paced, deadline-driven setting.
Willingness to learn, take on new challenges, and apply knowledge of proprietary software, platforms, and methods.
Independent thinking within role scope, good business judgment, and maintenance of project confidentiality.
Customer-service focus in responding to internal customer needs and delivering quality that meets or exceeds expectations.

Responsibilities

Plan, design, and perform laboratory experiments for solid tumor assay development, optimization, troubleshooting, and validation.
Independently execute complex, full-scale experiments with limited supervision, including multi-condition studies, appropriate controls, and sample-selection strategies aligned to study objectives.
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, when conducting experiments and interpreting results.
Perform nucleic acid extraction and molecular methods as required, including NGS library preparation and related assays; interpret NGS quality metrics and experimental outcomes.
Troubleshoot technical assay issues, recommend and conduct verification tests, and discuss experimental options with the scientific lead and project team.
Maintain laboratory equipment and required logs; manage, log, and store reagents, samples, and supplies; and create tracking documentation for materials and experiments.
Train Molecular Lab Operations Specialists, Molecular Technologists, and PDV Associates in methods when methods are implemented or changed, or as otherwise required.
Complete assigned training and competencies in a timely manner.
Contribute to development and analytical verification/validation study design, including scientific rationale, sample requirements, experimental conditions, and acceptance criteria, in collaboration with other Caris teams.
Draft, review, and revise experimental plans, validation plans, protocols, reports, SOPs, forms, and other controlled documents supporting assay development, validation, transfer, and launch.
Analyze average-to-complex datasets, such as NGS quality statistics, concordance, correlation, precision, and experimental-condition comparisons, and produce 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 productively and professionally within PDV and across Caris.
Maintain high-quality work, take ownership of assigned experiments and documents through completion, and pursue results and continuous improvement.
Accept other duties as assigned.