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Technical Manager, Laboratory Operations
2 months ago
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. Learn more about us at biodesix.com.
OBJECTIVE OF THE POSITION:
The Technical Manager of Laboratory Operations will have responsibilities for day-to-day oversight of the Commercial Laboratory Operations facilities at Biodesix. Key responsibilities include assistance in the setup and ongoing daily management of the day-to-day operations of Commercial test realization in the laboratory (specimen receipt through results). The candidate will have a strong technical and/or experience required to perform all job functions, including sample accessioning and test processing using standard in-vitro laboratory techniques, and to access a proprietary LIMS. The position will also work closely with the Department head, Lab Director(s), technical leads and Customer Service. Key function of this role is to serve as the General Supervisor for the Laboratory technical staff in daily execution against test realization deliverables.
The position will necessarily work closely with other cross-functional team members in Operations support, Legal, Human Resources, Facilities, Quality and Regulatory. Ongoing training will be provided to supplement key skills required to perform the functions of this position as applicable.
Competence in this role ensures on-going compliance of the laboratory with all federal, state, and local regulations.
Appropriate designees may act as responsible delegates according to the Biodesix Quality Matrix, including day to day responsibilities required for CAP/CLIA 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:
Either directly, or by delegation, Sr Manager, Laboratory Operations has responsibilities to:
• Ensure laboratory performs in compliance with, where applicable, CAP/CLIA and GLP/GMP, ISO13485, FDA and CE-mark standards
• Perform key administrative tasks to support the function of the Laboratory
• Assume responsibilities as the General Supervisor, CLIA and NYS, as required
• Manage compliance of laboratory records, facilities, and environmental monitoring in accordance with laboratory SOPs and EHS requirements
• Coordinate test results upload to the Customer Service team
• Coordinate test reviews and approvals with respective Laboratory Directors
• Contribute to laboratory budget and forecasting, including for laboratory supply inventory, as well as to department quality and test delivery metrics
• Supervise laboratory technical staff in day-to-day activities
• Create, edit, and review Laboratory SOP
• Perform competency assessment of laboratory staff
• Perform routine testing of samples according to established SOP
• Oversee laboratory maintenance duties as required and in accordance with laboratory SOPs
• Contribute to on-going performance assessment of laboratory staff
• Communicate effectively with all management and support teams
• Must be able to work independently and have exceptional written and verbal skills
• Participate in CE program
COMPETENCY OR POSITION REQUIREMENTS:
• Demonstrated working knowledge of testing procedures, HIPAA, laboratory safety procedures, mathematical, interpersonal, communication, and supervisory skills
• Management role requires demonstrated management skills in dealing with conflict, uncertainty, and ambiguity
• Management role requires demonstrated team development and leadership skills with laboratory professionals
• Exceptional organizational and documentation skills
• Exceptional attention to detail is required.
• Competency in Microsoft Office (SharePoint, Teams, Word, Excel, PowerPoint)
EDUCATION AND EXPERIENCE:
• A minimum of six years of recent and related experience in a CLIA high-complexity testing laboratory, or comparable experience is required to perform General Supervisor role
• Bachelor's degree in Chemistry, Biology, or other life science, preferred. Other certification in Medical Technology and experience in Clinical Laboratory testing will be considered
UNPLANNED ACTIVITIES:
• Other duties as assigned
TRAVEL PERCENTAGE:
• Minimal
COMPENSATION:
We are excited to provide:
• Competitive compensation $83,800 to $98,600 annually
• Individual base compensation is based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related aspects.
• Discretionary Bonus opportunity
• Comprehensive benefits package - effective date of hire
• Medical
• Dental
• Vision
• Short/Long Term Disability
• Life Insurance
• Flex Spending Account
• 401(k)
• 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
JOB LOCATION:
• On-Site in Louisville, CO
SCHEDULE:
• Wednesday to Sunday
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.
