Clinical Laboratory Scientist III

Location: Boulder, Colorado, United States

Schedule: Multiple shifts Monday through Saturday between 8 am and 8 pm

About our Company:  Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.     

About the Role:  The Clinical Laboratory Scientist III will be responsible for performing a variety of laboratory procedures involved in end-to-end processing of biological samples to enable successful downstream next-generation sequencing (NGS). Processing will include accessioning and both manual and automated extraction, library preparation, hybrid capture, sequencing and QC steps. Under the guidance of the Director of Clinical Laboratory Operations and the Laboratory Director, you will work collaboratively within the clinical laboratory leveraging your technical knowledge, skills and abilities to ensure efficient and quality results are provided to our clients and patients. The Clinical Laboratory Scientist III will also inform and participate in process improvements through ownership and leadership. This position will report to the Director of Clinical Laboratory Operations.

What You Will Bring:

• 6+ years of relevant laboratory work experience

• 2+ years Experience in ISO 13485/15189, GLP and or CAP/CLIA environments 

• Bachelor’s or Master's degree in chemical, physical, biological, or clinical laboratory science or medical technology from an accredited institution

  • Education received at a college or university located outside of the United States or United States Territories requires a credentials equivalency evaluation by an approved agency

• Hold a current and active American Society of Clinical Pathology (ASCP) board certification

• Hold current and valid Clinical Laboratory Scientist licensure (Generalist or CGMBS)

• Experience performing complex molecular biology workflows, ideally NGS workflows

• Previous experience designing and performing validations and verifications, process development and process-directed documentation

• Experience in complex problem-solving and risk management/mitigation (i.e. identify potential equipment or chemistry failures)

What You Will Do:

Technical

• Perform routine and complex diagnostic laboratory testing on patient samples for clinical, biopharma, and academic partnerships.

• Provide technical guidance and oversight to licensed and non-licensed personnel for pre-analytical, analytical and post-analytical activities.

• Interpret data and results of all analyses according to set procedures and guidelines.

• Support day to day operations by assisting with data entry, receiving samples and consumables, reagent preparation, sample preparation, temperature recording, laboratory maintenance and documentation.

• Identify and resolve problems that may adversely affect test performance or reporting of test results following the escalation path to clinical leadership as needed.

• Assist with research, translational research, regulated products through the execution of partnership studies and internal/external validation studies.

• Participate as a contributing member of the clinical laboratory by assisting in routine activities, to include but not limited to general upkeep and stocking, SOP author and review, and continuous improvement.

• Proposes assay and process improvements and conducts improvement activities under guidance.

• Demonstrate forward thinking and initiative in work planning and execution of work in order to achieve on-time report delivery.

• Participate in new or revised assay launches giving input on launch logistics as appropriate.

• Participate in work planning initiatives and scheduling.

• Utilize understanding of d/pFMEA, failure modes and phenotypes for the assay chemistry and instrumentation to support risk assessment and remediation.

• Author standard operating procedures (SOPs), process maps, decis