Clinical Laboratory Scientist III
Foresight Diagnostics
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.
Responsibilities
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, decision trees, and/or training program materials to facilitate successful implementation of instrumentation into the clinical laboratory testing workflow.
May operate as a General Supervisor.
Quality, Training & Equipment
Maintaining documentation in compliance with Good Laboratory Practices and Quality Systems.
Assist with quality control and quality assurance activities. Responsible for reviewing and analyzing the health of laboratory quality metrics in collaboration with clinical leadership.
Complete initial training and maintain competencies as current and up to date for all trained assays.
Wear appropriate PPE as required and comply with safety rules and regulations.
Follow standard operating procedures (SOP).
Participate in IQ/OQ/PQ for equipment to ensure ability to train team members on proper use and maintenance as appropriate.
Escalate equipment issues that impact TAT or patient safety.
Assist, perform, and review instrument correlation studies. Collaborate with operational leadership on equipment analysis for assay expansion or improvement.
Perform instrument and procedural calibrations and maintenance.
Advises and drives progress on troubleshooting equipment issues.
Adhere to the laboratory's quality control policies including document control activities, change management, corrective preventative action.
Train internal clinical team to new instrumentation, products, processes, or assays to support successful implementation in the clinical laboratory.
Team
Cultivate, build and maintain positive and collaborative relationships within teams and cross-functionally.
Operate as a thought leader and hold cross-functional teams accountable to regulatory, quality, scientific and performance standards to ensure the highest quality for sample integrity.
Seen as a role model for safety behavior standards and cultural tenets.
Serves as a leader from the bench, demonstrating consistency in good lab practices.
Knowledge, Skills and Abilities
6+ years of relevant laboratory work experience
2+ years Experience in ISO 13485/15189, GLP and or CAP/CLIA environments
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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
Experience with implementing and performing histology processes, preferred
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)
Working Conditions and Physical Effort
Staff in this role must be able to perform the essential functions of the job with or without a reasonable accommodation. Certain physical activities may be required in order to perform the essential functions of this job. Examples of these requirements include but are not limited to the following:
This role is offering an hourly wage between $51.44 - 59.38 and is eligible for equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is June 15, 2024.
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.