Position Summary

The qualified candidate will be working in the Assay Development and Validation Department. The individual will play a critical role in supporting the development, validation, transfer, establishment, troubleshooting, and successful launch of new molecular assays, instrumentation, and methodologies into the clinical laboratory. Furthermore, the candidate will be responsible for planning, designing, assisting with, and performing various laboratory experiments, documentation, inventory tracking, data analysis, summarization, presentation, and transfer of knowledge to other team members and departments. Development Associates are expected to contribute both technically and intellectually to optimize quality and efficiency for Caris’ pipeline of development projects.

Job Responsibilities

• Participate in developing new assays and optimize previously validated assays to increase sensitivity, specificity, reproducibility, reduce costs and turn-around-time, while maintaining a high-degree of quality in performance.

• Assist with troubleshooting both established and assays under development.

• Actively update knowledge and understanding of new and emerging technologies.

• Perform technical tasks including, but not limited to, sample preparation, RNA and DNA extractions, PCR and real-time PCR, enzymatic reactions, column and magnetic bead-based sample purification, libraries preparation for Next Generation Sequencing.

• Participate in planning and execution of experiments.

• Document development and validation activities, following good documentation practices and maintaining established organizational structure.

• Help with analyzing data and summarizing results.

• Follow all applicable quality and regulatory guidelines as they relate to specific assay validation projects.

• Maintain all competencies and training as assigned.

• Maintain laboratory equipment, including completing logs and maintenance, e.g., clean, sterilize, maintain, and shut down laboratory equipment, accessories, and instruments used in PDV experiments, daily and weekly as required.

• Receive and store inventory of reagents and supplies.

• Train Molecular Lab Operations Specialists, Molecular Technologists, and PDV Associates in new technologies, upon implementation of technology changes, or upon hire.

• Assist in drafting SOPs, forms, and other documents in support of development, validation, and launch of new or improved assays.

• Manage inventory of reagents and supplies.

• Alert the team to opportunities in leveraging relevant new and emerging technologies.

• More independent data analysis, documentation and reporting.

• Accept other duties as assigned.

Required Qualifications

• Bachelor’s degree in a Molecular Biology, Molecular Genetics, Biochemistry, or related fields is required.

• 2 years post-graduation experience in research or clinical lab.

• Hands-on experience in the following: RNA/DNA extractions from various biological material, assays for nucleic acid quantification and QC, PCR, Next Generation Sequencing library preparation, automated liquid handling systems processing, operation of NGS platforms (ideally Illumina), data analysis, and database entry.

• Demonstrate clear ability to explain previous molecular assay experience, including the function of positive/negative controls, sample results, and data interpretation.

• Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, general working knowledge of Internet for business use, and skilled in operating office equipment such as copiers and scanners.

Preferred Qualifications

• Real time PCR

• Automation of laboratory processes.

• High-throughput assays development and application.

Physical Demands

• Occasional lifting of items up to 40 lbs.

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.

• Job may require after-hours response to emergency issues.

• Occasionally may require working evenings/weekends.

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.