“Biodesix requires all new hires to be fully vaccinated against COVID-19 and provide valid proof of vaccination as of their start date, to the extent permitted under state and federal law.
This requirement is a condition of employment at Biodesix, and it applies regardless of whether the position is located at a Biodesix site, field based or is fully remote. If you are unable to receive the vaccine due to a medical condition (including pregnancy-related), or because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation from Human Resources.”
Biodesix is a leading diagnostic 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 is the first company to offer six non-invasive tests for patients with diseases of the lung. Biodesix launched the SARS-CoV-2 ddPCR™ test and the Platelia SARS-CoV-2 Total Ab in response to the global pandemic and virus that impacts the lung and causes COVID-19. The blood based Biodesix Lung Reflex® strategy for lung cancer patients integrates the GeneStrat® and VeriStrat® tests to support treatment decisions with results in 72 hours, expediting time to treatment. The blood based Nodify Lung™ nodule risk assessment testing strategy consisting of the Nodify XL2™ test and the Nodify CDT™ test evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. Biodesix also collaborates 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.
OBJECTIVE OF THE POSITION:
This full-time position will have primary responsibilities to plan and execute projects in the Product Development team. Projects will include transfer of product concepts from the internal research team or external technology partners, development of concepts to transfer and launch implementation in collaboration with our Laboratory Operations team. The ideal candidate is team oriented, technically sound, driven to execute, and very attentive to project goals. This candidate will also be attentive to the project aims, able to read and comprehend peer-reviewed published literature, collaborate with colleagues internally and externally on focused projects and document plans and results within notebooks and in formal documents within the QMS. Advancement is dependent on the ability to work with decreasing levels of supervision as well as recognized delivery in compliance with the Product Development Policy and Process.
The Research Associate has the opportunity to broaden their technical skills by cross-training in genomic and proteomic technologies. Responsibilities include assisting with applied research and development including ongoing daily management and performance of established laboratory test processes, as well as ensuring on-going compliance with all federal, state, and local regulations which govern the operation of the laboratories. This position will be required to gain and maintain competence in the Laboratory Operations testing procedures, routinely execute at the bench including processing of human blood, tissue, and cell samples in a high complexity testing Laboratory.
In summary, the candidate will have a strong scientific and technical background and including trouble-shooting laboratory experiences, be competent with the peer-reviewed literature, conducting independent data analyses, be compliant with Good Laboratory Practices (GLP) including with documentation, competent in developing plans and reports in our Quality Management System and deliver technical presentations on projects. Ongoing training will be provided to supplement key skills required to perform the functions of this position as applicable.
As a Research Associate I, this role shall comply, at a minimum, with the responsibilities outline 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, Chemistry, Director Responsibility and Authority and Molecular Pathology 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, WA Medical Test Site (MTS)
• 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
• May perform other duties as required or assigned.
COMPETENCY OR POSITION 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
EDUCATION AND EXPERIENCE:
• B.S. in Chemistry/Molecular Biology/Biochemistry, or closely related field. May also include exceptional individuals without these academic credentials by approval.
Other duties as assigned.
This position is eligible for both annual equity awards and our short-term incentive program.
Biodesix provides paid healthcare, including medical, dental and vision, and a competitive paid vacation and sick leave program. Please visit our website for additional details. www.biodesix.com/careers/benefits
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.