Development Associate II

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 and successful launch of new molecular assays, instrumentation, and methodologies into the clinical laboratory. Candidate will be responsible for assisting with planning, designing, and performing various laboratory experiments, documentation, reagents receiving, storing and tracking, data analysis, summarization and presentation, transfer of knowledge to other team members and to other departments, training clinical personnel, as well as additional functions fit for the position. Development Associates are expected to contribute both technically and intellectually to optimize quality and efficiency for Caris’ pipeline of development projects.

Job Responsibilities

• Work closely with team members to support ongoing development, troubleshooting, and validation of lab protocols and database systems.

• Participate in execution of experiments.

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

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

• Perform Proficiency Testing in a timely manner and submit results to supervisors.

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

• 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, manage, log, and store inventory of reagents and supplies; create tracking documentation and QC forms.

• Accepts other duties as assigned.

Required Qualifications

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

• Minimum 1 years in research or clinical lab.

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

• Hands-on experience in some (not all) of the following technologies are required: RNA/DNA extractions from various biological material, assays for nucleic acid quantification and QC, PCR and real time PCR, Next Generation Sequencing, familiarity with automated liquid handling systems, experience with NGS platforms (ideally Illumina), data analysis, and database entry.

• Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, power point and general working knowledge of Internet for business use.

• Conditions of Employment: Individuals must successfully complete pre-employment process, which includes criminal background check, drug screening, and reference verification.

Preferred Qualifications

• Proficiency in MS Excel VBA macros or other coding language.

• Laboratory automation.

• High-throughput assays development and application.

• NGS experience is a plus.

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.