Senior Research Associate
Biodesix
ABOUT US:
Biodesix is a leading diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS® test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, please visit www.biodesix.com. JOB LOCATION:
Louisville, CO - On-Site
OVERVIEW:
RESPONSIBILITIES: Develop and optimize procedures for human specimen sample preparation from tissue, cells, whole blood, plasma, and serum for diagnostic assays Plan and execute early feasibility, verification and validation within the Development and Operations teams Plan and execute multiple studies according to SOP and in collaboration with relevant cross-functional teams Serve as a technical resource within the laboratories as required Perform experimental setup, including assisting with data analysis using appropriate statistics software package(s) Analyze data and prepare technical plans and reports, summaries, protocols, and quantitative analysis and ensure experiments are well documented Maintain competence in relevant on-market tests with availability as testing personnel in Laboratory Operations as required Contributes to peer reviewed publications, patent preparation and review, presentations at Nationals and International meetings Monitors work to ensure quality Maintains CE compliance
REQUIREMENTS: Technical level will be benchmarked based on laboratory experience and technical competency Proficient in laboratory handling of human specimens, including whole blood, tissue, and cells Excellent laboratory technical skills with various molecular and pre-analytic techniques including sample preparation, PCR, NGS and mass spectrometry instrumentation Proficient in computer skills including Microsoft Office software and common statistical analysis tools Team player that is willing to share, assist and mentor team members of variable technical competencies to ensure the success of diverse projects Demonstrated ability to comply with required established testing procedures, laboratory safety procedures, HIPAA, analytic, interpersonal, communication, and supervisory skills Ability to generate peer-reviewed publications, participate in scientific Journal clubs, create, and present findings at National and International forums Competency in Microsoft Office (SharePoint, Teams, Word, Excel, PowerPoint) Ability to work well in a team environment with strong work ethic Ability to meet timelines while keeping team update on progress and hurdles EDUCATION AND EXPERIENCE: B.S. in Chemistry/Molecular Biology/Biochemistry, or closely related field required. 4 Years Minimum of relevant experience as a Research Associate, required
REGULATORY REQUIREMENTS: This role is governed by the following regulatory requirements, at a minimum, with the responsibilities and qualifications outlined: CLIA: Clinical Laboratory Improvement Amendments (CLIA) Requirements, Title 42 Code of Federal Regulations Part 493 CAP: College of American Pathologists (CAP): All Common, Laboratory General, Chemistry, and Toxicology, Director Assessment, Microbiology, Immunology, and Molecular Pathology 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 COMPENSATION: Annual Compensation range $64,800 to $76,200 Discretionary Bonus opportunity Comprehensive health coverage: Medical, Dental, and Vision Insurance: Short/Long Term Disability and Life Insurance Financial benefits: 401(k), Flex Spending Account 120 hours of annual vacation 72 hours of paid sick time off 11 paid holidays + 3 floating holidays Employee Assistance Program Voluntary Benefits Employee recognition program Individual base compensation is based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related aspects.
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.
Biodesix is a leading diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® targeted ddPCR™ test, the GeneStrat NGS® test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of two to three business days, expediting the time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, please visit www.biodesix.com. JOB LOCATION:
Louisville, CO - On-Site
OVERVIEW:
This full-time role involves planning and executing projects within the Product Development team, including transferring product concepts from internal or external partners, developing these concepts, and collaborating with the Laboratory Operations team for implementation. The ideal candidate is team-oriented, technically proficient, goal-driven, and capable of reading peer-reviewed literature, collaborating on focused projects, and documenting results in the Quality Management System (QMS). Advancement will depend on independent work and adherence to Product Development policies.
The role offers cross-training in genomic and proteomic technologies and involves managing and performing laboratory test processes, ensuring compliance with regulations. The candidate will process human samples in a high-complexity lab, troubleshoot issues, conduct independent data analysis, and comply with Good Laboratory Practices (GLP). Proficiency in developing plans, reports, and delivering technical presentations is expected, with ongoing training provided as needed.
RESPONSIBILITIES: Develop and optimize procedures for human specimen sample preparation from tissue, cells, whole blood, plasma, and serum for diagnostic assays Plan and execute early feasibility, verification and validation within the Development and Operations teams Plan and execute multiple studies according to SOP and in collaboration with relevant cross-functional teams Serve as a technical resource within the laboratories as required Perform experimental setup, including assisting with data analysis using appropriate statistics software package(s) Analyze data and prepare technical plans and reports, summaries, protocols, and quantitative analysis and ensure experiments are well documented Maintain competence in relevant on-market tests with availability as testing personnel in Laboratory Operations as required Contributes to peer reviewed publications, patent preparation and review, presentations at Nationals and International meetings Monitors work to ensure quality Maintains CE compliance
REQUIREMENTS: Technical level will be benchmarked based on laboratory experience and technical competency Proficient in laboratory handling of human specimens, including whole blood, tissue, and cells Excellent laboratory technical skills with various molecular and pre-analytic techniques including sample preparation, PCR, NGS and mass spectrometry instrumentation Proficient in computer skills including Microsoft Office software and common statistical analysis tools Team player that is willing to share, assist and mentor team members of variable technical competencies to ensure the success of diverse projects Demonstrated ability to comply with required established testing procedures, laboratory safety procedures, HIPAA, analytic, interpersonal, communication, and supervisory skills Ability to generate peer-reviewed publications, participate in scientific Journal clubs, create, and present findings at National and International forums Competency in Microsoft Office (SharePoint, Teams, Word, Excel, PowerPoint) Ability to work well in a team environment with strong work ethic Ability to meet timelines while keeping team update on progress and hurdles EDUCATION AND EXPERIENCE: B.S. in Chemistry/Molecular Biology/Biochemistry, or closely related field required. 4 Years Minimum of relevant experience as a Research Associate, required
REGULATORY REQUIREMENTS: This role is governed by the following regulatory requirements, at a minimum, with the responsibilities and qualifications outlined: CLIA: Clinical Laboratory Improvement Amendments (CLIA) Requirements, Title 42 Code of Federal Regulations Part 493 CAP: College of American Pathologists (CAP): All Common, Laboratory General, Chemistry, and Toxicology, Director Assessment, Microbiology, Immunology, and Molecular Pathology 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 COMPENSATION: Annual Compensation range $64,800 to $76,200 Discretionary Bonus opportunity Comprehensive health coverage: Medical, Dental, and Vision Insurance: Short/Long Term Disability and Life Insurance Financial benefits: 401(k), Flex Spending Account 120 hours of annual vacation 72 hours of paid sick time off 11 paid holidays + 3 floating holidays Employee Assistance Program Voluntary Benefits Employee recognition program Individual base compensation is based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related aspects.
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.
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