Clinical Laboratory Scientist

Prelude Corporation; Laguna Hills (CA); On-site; USD 94,000 - 104,000; Full time

Job summary

PreludeDx is seeking a licensed Clinical Laboratory Scientist to join our R&D team in Laguna Hills, CA. The ideal candidate has experience in Next Generation Sequencing (NGS) and molecular biology techniques.

Responsibilities include calibrating and maintaining equipment, running NGS workflows, data analysis, and training other staff, with CAP/CLIA compliance and thorough record-keeping. Hours are 8am to 5pm, compensation $45–$50/hour.

Qualifications

• Minimum 4 years as a certified or licensed clinical laboratory scientist.
• California Clinical Laboratory Scientist (Highly Preferred: CGMBS license).
• Experience with Macrodissection, RNA extraction and downstream analysis.
• Strong experience in development of targeted library, conducting sequencing library preparation, sequencing, and data analysis.
• Experience in project management and organization.
• Excellent record-keeping and documentation skills.
• Strong communication skills and ability to work in a team-oriented environment.
• Preferred Bachelor’s or Master’s degree in Molecular Biology, Biochemistry, or related field.
• Minimum of 4 years of molecular and histology experience within an anatomic pathology laboratory or clinical laboratory.

Responsibilities

• Ensure that the equipment is calibrated, maintained, and operated according to the manufacturer’s guidelines and standard operating procedures.
• Adheres to the CAP, CLIA and NYS regulations.
• Run protocols for sample collection, processing, storage, and tracking in LIMs to ensure the integrity and traceability of the samples throughout the NGS workflow.
• Run clinical and R&D samples for NGS and molecular biology techniques, including microdissection, FFPE nucleic acid extraction, NGS library preparation, sequencing, data analysis, and quality control measures with appropriate NGS controls.
• Perform and train other CLS’s on established NGS and molecular biology procedures, including macrodissection, FFPE nucleic acid extraction, NGS library preparation, sequencing, and data analysis, including quality control measures.
• Perform validation testing to ensure with selected reagents and controls to ensure the assay meets the required performance specifications.
• Perform validation studies to assess the performance characteristics of the NGS assay, including sensitivity, specificity, accuracy, precision, and reproducibility.
• Analyze and interpret data using appropriate statistical methods and software, including sensitivity, specificity, accuracy, precision and reproducibility.
• Maintain accurate records and documentation of experiments and results.

Job description

Great people form the core of any great organization. PreludeDx is always looking for highly qualified people with a passion for improving the lives of cancer patients. We will periodically post information about openings but are always interested in hearing from those who believe in our mission and values.

JOB TITLE: Clinical Laboratory Scientist
DEPARTMENT: R&D
REPORTS TO: CLS Manager
LOCATION: Laguna Hills, CA
COMPENSATION: 45-50/hour
HOURS: 8am to 5pm

JOB PURPOSE:

We are seeking a highly motivated and skilled licensed CLS to join our team. The ideal candidate will have experience in running Next Generation Sequencing (NGS) and knowledge of molecular biology techniques.

ESSENTIAL RESPONSIBILITIES:

• Ensure that the equipment is calibrated, maintained, and operated according to the manufacturer’s guidelines and standard operating procedures.
• Adheres to the CAP, CLIA and NYS regulations.
• Run protocols for sample collection, processing, storage, and tracking in LIMs to ensure the integrity and traceability of the samples throughout the NGS workflow.
• Run clinical and R&D samples for NGS and molecular biology techniques, including microdissection, FFPE nucleic acid extraction, NGS library preparation, sequencing, data analysis, and quality control measures with appropriate NGS controls.
• Perform and train other CLS’s on established NGS and molecular biology procedures, including macrodissection, FFPE nucleic acid extraction, NGS library preparation, sequencing, and data analysis, including quality control measures.
• Perform validation testing to ensure with selected reagents and controls to ensure the assay meets the required performance specifications.
• Perform validation studies to assess the performance characteristics of the NGS assay, including sensitivity, specificity, accuracy, precision, and reproducibility.
• Analyze and interpret data using appropriate statistical methods and software, including sensitivity, specificity, accuracy, precision and reproducibility.
• Maintain accurate records and documentation of experiments and results.

The above list represents the general duties considered essential functions of the job and is not to be considered an exhaustive description of all the work requirements that may be inherent in the position

POSITION REQUIREMENTS:

• Minimum 4 years as a certified or licensed clinical laboratory scientist
• California Clinical Laboratory Scientist (Highly Preferred: California Clinical Genetic Molecular Biologist Scientist license – CGMBS.)
• Must be well-organized, open-minded, decisive, and flexible. They must be able to communicate well with others, and work as a team. Good writing skills and and extensive computer experience are necessary
• Experience with Macrodissection, RNA extraction and downstream analysis
• Strong experience in development of targeted library, conducting sequencing NGS library preparation, sequencing, and data analysis
• Experience in project management and organization
• Excellent record-keeping and documentation skills
• Strong communication skills and ability to work in a team-oriented environment
• Validation and SOP writing experience a plus
• Must have superior work ethic, high energy level and be results oriented
• Internally motivated and self-starter; ability to make an impact
• Comfortable in a fast-paced environment
• Excellent oral and written communication skills
• Candidate must be a fast learner, naturally oriented toward problem solving, have superior work ethic, high energy level and be ambitious; good organizational skills
• Preferred Bachelor’s or Master’s degree in Molecular Biology, Biochemistry, or related field
• CLS license 4+ years
• Highly Preferred: California Clinical Genetic Molecular Biologist Scientist license – CGMBS
• Anatomic or Clinical Pathology experience
• Prior experience with NextGen sequencing instruments.
• Minimum of 4 years of molecular and histology experience within an anatomic pathology laboratory or clinical laboratory.

ABOUT PRELUDEDX

PreludeDx is an Innovative Healthcare company and leading personalized breast cancer diagnostics company dedicated to serving breast cancer patients and physicians worldwide. Founded in 2009 with technology licensed from University of California San Francisco, PreludeDx has focused on developing precision breast cancer tools that will impact a patient’s treatment decision. Our mission is to provide patients and physicians with innovative technologies that improve patient outcomes and reduce the overall cost burden to the healthcare system. Before making a treatment decision, Know Your Risk™.