The Solid Tumor Scientist is expected to execute complex experiments independently, generate meaningful conclusions, and communicate clearly in a cross functional manner. The role requires working knowledge of regulated study design (analytical verification and validation for laboratory-developed tests and, as applicable, in vitro diagnostics) and the interpersonal skills to work effectively with Assay Development, Molecular Operations, Bioinformatics/Statistics, Quality Assurance, Regulatory Affairs, Translational Science, and other stakeholders.
Job Responsibilities
Plan, design, and perform laboratory experiments in support of solid tumor assay development, optimization, troubleshooting, and validation.
Execute complex, full-scale experiments with limited supervision/directives, including multi-condition studies, appropriate controls, and sample-selection strategy aligned to the study objective.
Apply knowledge of solid tumor specimen types and pre-analytical variables (including FFPE tissue, tumor cellularity/necrosis, nucleic acid yield and quality, and sample adequacy) when executing 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 assays technical issues; recommend and execute verification tests; discuss experimental options with the scientific lead and project team to answer the experimental question.
Maintain laboratory equipment, including completing logs and maintenance as required; manage, log, and store inventory of reagents, samples, and supplies; create tracking documentation associated with materials and experiments.
Train Molecular Lab Operations Specialists, Molecular Technologists, and PDV Associates in methods upon implementation, method changes, or as required.
Complete assigned training and competencies in a timely manner.
Contribute to study design for development and analytical verification/validation work, including scientific rationale, sample requirements, experimental conditions, and acceptance criteria, in collaboration with other Caris teams as required.
Draft, review, and revise experimental plans, validation plans, protocols, reports, SOPs, forms, and other controlled documents in support of development, validation, transfer, and launch of new or assay revisions.
Analyze data of average-to-complex datasets (for example NGS quality statistics, concordance, correlation, precision, and comparison of experimental conditions) and generate clear, scientifically sound conclusions and recommendations.
Presents experimental results, issues, risks, and proposed next steps within PDV and Caris-wide as needed.
Follow all applicable quality and regulatory requirements as they relate to assay development and validation projects (including CAP/CLIA, New York State, MolDx and internal quality system expectations).
Translate scientific rationale into clear written and verbal guidance so executing teams and cross-functional partners understand why a study is designed as it is.
Communicate productively and professionally within PDV and Caris-wide.
Exhibit consistent high quality of work, ownership of assigned experiments and documents through completion, and a drive for results and continuous improvement.
Accepts other duties as assigned.
Required Qualifications
Master’s degree in Molecular Biology, Molecular Genetics, Biochemistry, Oncology, Cancer Biology, or a related life-sciences field, with min 4 years of relevant experience in a research, translational, or clinical molecular laboratory; or
Ph.D. in Molecular Biology, Molecular Genetics, Biochemistry, Oncology, Cancer Biology, or a related life-sciences field, with 1–3 years of relevant postdoctoral or industry experience.
Equivalent combinations of education and relevant industry experience may be considered.
Demonstrated ability to explain prior molecular assay experience, including the function of positive/negative controls, sample results, and data interpretation.
Working knowledge of regulated study design for molecular assay development and analytical validation (for example accuracy/concordance, precision, LoD/sensitivity, LoB, specificity, and appropriate controls).
Hands-on molecular biology laboratory skills and the ability to operate independently on complex laboratory tasks.
Comfort working as both a bench scientist and a desk scientist: executing experiments, analyzing data, writing study documents, and presenting results.
Familiarity with nucleic acid extraction from solid tumor specimens, bone marrow and with NGS and/or targeted molecular methods (library preparation, sequencing, and interpretation of NGS quality statistics).
Ability to generate meaningful conclusions from multi-condition experiments and to summarize data for scientific and operational audiences.
Effective verbal and written communication skills, including the ability to share and receive information across levels of the organization and to work constructively with interdisciplinary teams.
Proficiency in Microsoft Office Suite (Word, Excel, Outlook) and general working knowledge of Internet for business use.
Experience contributing to Quality Management System deliverables, risk assessments (FMEA), design reviews, or regulatory submission content (for example FDA 510(k), PMA, EUA, IVDR) for NGS-based oncology or companion diagnostic assays.
Knowledge of laboratory safety procedures for biohazards and chemicals, as well as quality-control procedures and regulations.
Preferred Qualifications
The following items distinguish stronger candidates. Translational and regulated-product experience is desired as a bonus and is not required for this requisition.
Experience with solid tumor comprehensive genomic profiling or related oncology NGS panels (DNA and/or RNA), including variant classes such as SNVs/indels, copy-number alterations, fusions/splice variants, MSI, TMB, and/or HRD.
Laboratory automation experience across multiple platforms (for example Beckman, Agilent, Hamilton, Tecan, SPT) and high-throughput assay development or application.
Multiple NGS platform experience and mastery of 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 (FDA 21 CFR Part 820, ISO 13485, IVDR, or equivalent).
Scientific writing experience (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. Strong understanding of the scientific process, including hypothesis development, experimental design, selection of controls, and data integrity.
Regulated-study mindset. Designs and documents work so that it can stand up to internal quality review and, where applicable, external regulatory scrutiny.
Lab-and-desk versatility. Moves effectively between bench execution and written analysis, documentation, and presentation without dropping quality on either side.
Cross-functional communication. Translates complex scientific rationale into clear guidance for bench teams, quality/regulatory partners, and leadership; listens, shares information, and escalates issues appropriately and in a timely manner.
Drive for results. Ensures procedures and processes lead to quality outcomes and continually reassesses effectiveness to achieve continuous improvement.
Teamwork. Commitment to team and organizational goals; works in a positive, constructive way in a complex, multifunctional environment.
Ownership and organization. High degree of personal organization; excellent time management; ability to multi-task and operate in a fast-paced, deadline-driven setting.
Learning agility. Strong willingness to learn, take on new challenges, and apply knowledge of proprietary software, platforms, and methods.
Judgment and confidentiality. Exercises independent thinking within role scope; uses good business judgment and maintains project confidentiality.
Customer-service focus. Listens to internal customer needs (operations, quality, regulatory, medical) and delivers quality that meets or exceeds expectations.
Physical Demands
This position requires regular work both at a computer workstation and at the laboratory bench.
Visual acuity and analytical skill to distinguish fine details. Ability to pass a visual color discrimination test.
Manual dexterity to use common laboratory equipment and perform sterile techniques as required.
Must possess ability to sit and/or stand for long periods of time and to perform repetitive motion.
Occasional lifting of items up to 30–40 lbs.
May have exposure to high noise levels, fumes, and biohazardous materials in the laboratory environment, including chemicals that emit fumes. May be required to handle blood-borne pathogens and general laboratory reagents.
Training
All job-specific, safety, and compliance training are assigned based on the job functions associated with this employee.
Other
This position may require periodic travel.
This position may require after-hours response to emergency issues.
Occasionally may require working evenings, weekends, and/or holidays.
This position may require periodically scheduled on-call periods that may require after-hours response for technical emergencies, not explicitly related to assigned job responsibilities.
Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.
This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
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.
