VP - Laboratory Operations

Biodesix•De Soto, KS

1d•$173,900 - $231,900•Onsite

About The Position

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.

Requirements

Demonstrated capability to mentor and develop junior team members is strongly desired
Record of accomplishment in managing Laboratory Operations in a clinical reference laboratory or pharmaceutical testing environment
Training in performing biological assays utilizing analytical chemistry and biochemical approaches
Experienced in proteomics tests with a focus on applications for the clinic
Experience establishing and managing a high complexity diagnostics laboratory
Experience managing all aspects of a laboratory, including budgets, organization
Demonstrated experience of compliance
Experience managing, motivating, and mentoring staff, directing laboratory personnel to develop skills necessary for performing operations in a diagnostics laboratory
Experience directing the daily operations of a high-complexity testing CAP/CLIA accredited testing laboratory
A background of ensuring departmental compliance with all Regulatory, Quality and other FDA regulations
Superior verbal and written communication skills including ability to write reports, business correspondence, and review technical procedure manuals and reports
Ability to prepare/present information to groups including regulatory agencies, business and technology strategists, clients, auditors, customers, investors, and the general public
Ability to read, analyze and interpret professional journals, technical procedures, business reports and governmental regulations
Ability to solve ambiguous, complex problems and provide solutions in situations where only limited concrete knowledge exists
Uses professional concepts to contribute to the development of company policies, procedures, and on-going business needs
Ongoing training will be provided to supplement key skills required to perform the functions of this position as applicable

Responsibilities

Supervision of all services and procedures performed by the Laboratory Operations or Development team located in the De Soto laboratory
Comply with the Laboratory Continuing Education program and all other business assigned Trainings required for performance of job requirements
Development and maintenance of procedures and protocols, including product and service improvements to assure the compliant function of the laboratory
Supporting the preparation and filing of reports of all development and testing procedures performed by the laboratory
Participate in the development and refinement of product and service requirements, implementation of test development within laboratory operations, including but not limited to the improvements, LIMS, test ordering and test report delivery, vendor selection and qualification
Draft, review, edit and complete study plans and technical documents (validation studies) required for various stages of feasibility, development, improvement and for regulatory submissions
Participation in Quality review meetings, including in Lab Action Board (LAB) meetings
Participation in opening and closing meetings with regulatory/quality agencies
Provide External Development client and other academic and medical collaborators consultative support (as required)
Perform all duties of a laboratory Technical Supervisor as required by applicable laws, regulations, and accreditation standards
Contributes to Laboratory planning, budgets and forecasting
Contributes to planning and dissemination of company goals and objectives; for example, in clinical study design, new product development, strategic partnerships/collaborations, technology roadmap, publications and presentations
Executes efficiently against the overall goals of the company; for example, communication across departments regarding the status and challenges in the laboratory operation function
Presents at key scientific conferences in support of company objectives; examples include annual meetings of MSACL, ASMS, HUPO, as needed
All other duties as assigned
Sets team strategy, priorities, and performance expectations aligned to organizational goals
Drives talent development, succession planning, and workforce planning
Provides ongoing feedback and conducts performance evaluations
Promotes a culture of respect, collaboration, and belonging across the team and broader organization