ABOUT US: Biodesix is a leading diagnostic solutions company, driven to improve clinical care and outcomes for patients. Biodesix Diagnostic Tests support clinical decisions to expedite personalized care and improve outcomes for patients with lung disease. Biodesix Development Services enable the world’s leading biopharmaceutical, life sciences, and research institutions with scientific, technological, and operational capabilities that fuel the development of diagnostic tests, tools, and therapeutics. Our Mission: Transform patient care and improve outcomes through personalized diagnostics that are timely, accessible, and address immediate clinical needs. Our Vision: A world where patient diseases are conquered with the guidance of personalized diagnostics. For more information, please visit www.biodesix.com. JOB LOCATION: Louisville, CO - On-Site SCHEDULE: Tuesday-Saturday, 9am-5pm MT THE ROLE: Laboratory Technicians assist with the setup and support of the daily activities of our Colorado BSL2+ laboratory. In addition, Laboratory Technicians have the technical training and experience required to perform regulated clinical laboratory test realization (test specimen receipt through test result generation) using standard in-vitro laboratory techniques in polymerase chain reaction (PCR), next generation sequencing (NGS) and in Mass Spectrometry (MALDI-ToF and/or LC/MS). Our focus areas of test development are in lung diseases with a focus on pulmonology and oncology. This experienced candidate is comfortable with SOPs and Work Instructions, working with data, standard laboratory chemicals, human blood specimens and is versed in standard analytic techniques (sample preparation, PCR, nucleic acid isolation/purification and sequencing). The position also works in a functional matrix organization, including Development, Customer Service, Finance/ Accounting, Quality management team, the Laboratory Directors, Business Development, CDMA, and other departments as needed. Ongoing training will be provided to supplement key skills required to perform the functions of this position as applicable. This is a 100% on-site laboratory role. Must embrace a culture of transparency, willing and open to share data and technical knowledge, excellent communication skills, on time delivery of complete and quality results. Surfaces issues promptly to manager with follow through to a resolution. Appropriate designees may act as responsible delegates according to the established Roles and Responsibilities including day to day responsibilities required for CAP/CLIA/NYS CLEP as well as all state-specific requirements in which Biodesix is an approved test facility. REGULATORY REQUIREMENTS: This role shall comply, at a minimum, with the responsibilities and qualifications outlined in: CLIA: Clinical Laboratory Improvement Amendments (CLIA) Requirements, Title 42 Code of Federal Regulations Part 493 CAP: College of American Pathologists (CAP): All Common, General, Director Responsibility and Authority and all test-specific checklists NYS CLEP: New York State Department of Health, Clinical Laboratory Evaluation Program (CLEP), New York State Public Health Law, Article 5 Title 5 ISO: International Organization for Standardization (ISO) 13485, Quality Management Systems, Requirements for Regulatory Purposes, 2016 All other applicable state and regulatory governing authorities including but not limited to: CA, PA, RI, MD RESPONSIBILITIES: Completes training and Competency Assessment for all new and existing procedures Takes responsibility for completing continuing education requirements set by applicable regulatory and accrediting agencies Performs all test realization function in support of Biodesix products and services Performs duties in line with established SOP Enters appropriate data into LIMS Uploads appropriate data to the Customer Service team Contributes to the overall maintenance of laboratory equipment and supplies following SOPs Contributes to the creation and revision of Laboratory SOP in the QMS Contributes to the Internal Audit readiness through good documentation practices Performs all job functions in accordance with HIPAA Contributes to Development projects, as needed Communicates effectively with on-site and remotely located management/support teams Works independently and has exceptional written and verbal skills Other duties as assigned COMPETENCY OR POSITION REQUIREMENTS: Outstanding technical laboratory skills. Excellent attention to detail with a strong commitment to thoroughness and error-free execution of procedures Exceptional organizational and documentation skills Participate in CE program Knowledge of lab safety Basic computer skills required (Microsoft suite) Ability to work well in a team environment with strong work ethic EDUCATION AND EXPERIENCE: Bachelor’s degree in a chemical, physical, biological, or clinical laboratory science or medical technology OR equivalent laboratory training and experience meeting the requirements defined by CLIA A minimum of 2 years experience in a high complexity laboratory OR equivalent training WHAT YOU'LL GET:
Biodesix is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. |