Clinical Laboratory Scientist II

Natera•Boulder, CO, CO

3h•$47 - $59•Onsite

About The Position

Foresight Diagnostics, a Natera company, is seeking a Clinical Laboratory Scientist II for their Boulder, CO location. This role involves performing end-to-end processing of biological samples for next-generation sequencing (NGS), including accessioning, manual and automated extraction, library preparation, hybrid capture, sequencing, and quality control. The scientist will work under the guidance of the Director of Clinical Laboratory Operations and the Laboratory Director, collaborating within the clinical laboratory to ensure efficient and high-quality results. Responsibilities include technical execution of diagnostic tests, providing guidance to non-licensed personnel, data interpretation, supporting daily operations, problem-solving, assisting with research and validation studies, and contributing to process improvements and new assay launches. The role also involves maintaining documentation in compliance with Good Laboratory Practices, assisting with quality control, completing training, adhering to safety protocols, and participating in equipment validation and maintenance. Team collaboration, acting as a role model for safety and lab practices, and thought leadership in quality and regulatory standards are also key aspects of this position.

Requirements

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)
Demonstrate a working knowledge of the general biological principles that govern DNA biology
Possess a strong foundational understanding of common molecular biology techniques, such as PCR/qPCR, DNA ligation, and DNA extraction
Working level knowledge or ability to learn use of common molecular biology instruments; Agilent Tapestation/capillary electrophoresis, Qubit, plate readers, thermocyclers and other common laboratory instruments
Previous experience handling human biological materials is required
Working knowledge of how to safely operate in a BSL-2 environment is required
Previous experience handling, processing, and extracting DNA from biological specimens is required

Nice To Haves

Ability to learn use of common molecular biology instruments; Agilent Tapestation/capillary electrophoresis, Qubit, plate readers, thermocyclers and other common laboratory instruments

Responsibilities

Perform routine and complex diagnostic laboratory testing on patient samples for clinical, biopharma, and academic partnerships.
Provide technical guidance and oversight to 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.
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.
May act as trainer in place of designated trainer/training 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.