Clinical Laboratory Scientist - CAP/CLIA

SkylineDx is a leading-edge biotechnology company specializing in the development of diagnostic tests for critical conditions such as multiple myeloma and melanoma. Our revolutionary products, Sky92 and Merlin, are transforming the way these diseases are understood, managed, and treated.

The Clinical Laboratory Scientist (CLS) will perform clinical laboratory tests in the pre-analytical, analytical, and post-analytical phases in a CLIA/CAP certified environment and prepare reports for review and approval according to established procedures. The CLS will aid in writing technical Standard Operating Procedures (SOPs), perform phase-in of new reagent lot, test quality control samples, and compile quality control metrics. The CLS will help in performing and validating new equipment (Installation Qualification, Operation Qualification, Performance Qualification) and test methods under the direction of the CLS Laboratory Manager or Laboratory Director.

Essential Duties and Responsibilities:

• Accurately perform high complexity molecular testing using a variety of molecular biological methods including RNA-DNA isolation, PCR, reverse transcription, microarray hybridization, real-time PCR and DNA sequencing by following the established SOP’s
• Train to all SOPs related to the job function and adhere to all rules and protocols.
• Prepare clinical specimens for testing and identify specimen related problems.
• Perform QC activities for phasing in new lots of reagents and chemicals following the established SOPs.
• Review and approve Quality Control results.
• Identify problems that may adversely affect test performance or test results, and immediately notify the CLS Laboratory Manager or Laboratory Director.
• Document all corrective actions taken when test systems deviate from the laboratory's established performance specification.
• Assist in preparation of validation documentation of new tests and procedures as required.
• Maintain laboratory in a clean, functional state, as well as performing routine equipment maintenance, calibration verification / certification, and performing documentation in logs or forms, as required.
• Maintain the privacy and confidentiality of personal information according to HIPPA guidelines.
• Perform newly introduced tests to the laboratory that require defined skills.
• Effectively resolve common problems or able to check with group leaders when it is uncertain.
• Recognize and take appropriate action in response to critical values or unexpected results, and document action taken.

Requirements:

Education/Certification:

• Bachelor of Arts or Science in Molecular biology, biological sciences or related field.
• Current California license as a Clinical Laboratory Scientist (CLS) Generalist or CGMBS.

Experience/ Qualifications:

• Minimum of two years of experience performing testing of patient samples and related duties in a CLIA-regulated laboratory.
• Must possess relevant molecular skill set consisting of the molecular fundamentals, RNA and DNA extraction, PCR, reverse transcription, and gel electrophoresis.
• Demonstrate knowledge of specific instrument platforms, including test principle(s), what controls were in place, and analysis/ reporting of results.
• Ability to integrate and apply feedback in a professional manner.
• Ability to work as part of a team.

At SkylineDx

We live to make a difference. It is our mission to improve a patient’s quality of life by enabling them to benefit from personal insights at the genomic level of their disease. That means we are continuously innovating the world of gene signature-based diagnostic testing. That also means we have a unique blend of characteristics. We have our soft side. Our culture is oftentimes described as familial, warm, loyal and highly engaged. We have our rational side where exact sciences are driving our mission. And when needed our passionate side surfaces to clear the way so we can serve society with science based solutions.

Our quotes

#serviceisjoy

#valueformoney

#playtogethertowin

#amazingthingshappen

#cogitoergosum

#itsyourparty

Do apply!

Send your resume to Nezam Etemadi (HR Manager) at the link provided. If you have questions or want more information, don’t hesitate to contact us. You’ll find the contact details on our website. We will make sure it lands on the right desk!

Job Type: Full-time

Pay: $110,000.00 - $145,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Schedule:

• Monday to Friday

People with a criminal record are encouraged to apply

Application Question(s):

• Do you have experience in manual setup for qPCR?
• Have you used single-channel and multi-channel pipettes, as well as serological pipette controllers, in accordance with established protocols and procedures?
• How do you maintain proficiency in pipetting techniques to ensure reliable and reproducible results?
• Explain your experience with manual DNA/RNA extraction.

Experience:

• CLIA regulated laboratory: 2 years (Required)

License/Certification:

• California license as a CLS (Required)

Ability to Commute:

• San Diego, CA 92109 (Required)

Work Location: Hybrid remote in San Diego, CA 92109

Salary : $110,000 - $145,000