VP - Laboratory Operations

Biodesix, Inc.; De Soto (KS); On-site; USD 174,000 - 232,000; Full time

Benefits offered by this job

Discretionary Bonus opportunity

Comprehensive health coverage

Job summary

Biodesix in De Soto, KS seeks a VP of Laboratory Operations to lead day-to-day lab operations, ensuring CAP/CLIA compliance and strategic alignment with product development and services.

The role requires a PhD or MD with 10+ years in laboratory leadership, strong budgeting, and cross‑functional collaboration with regulators, clients, and collaborators to advance personalized diagnostics initiatives.

Qualifications

• Mentor and develop junior team members
• Experience managing Laboratory Operations in a clinical reference laboratory or pharmaceutical testing environment
• Training in performing biological assays utilizing analytical chemistry and biochemical approaches
• Experience 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
• Background in regulatory and quality compliance
• Experience directing daily operations of a high-complexity CAP/CLIA accredited laboratory
• Background ensuring regulatory and FDA compliance
• Strong written and verbal communication skills
• Ability to present information to regulators, clients, investors and the public
• Ability to read and interpret professional journals, procedures and regulations

Responsibilities

• Supervise all services and procedures in the De Soto laboratory
• Ensure compliance with CE program and trainings
• Develop and maintain procedures and protocols for compliant lab function
• Prepare and file reports of development and testing procedures
• Participate in test development within laboratory operations, including LIMS and test report delivery
• Draft and review study plans and validation studies for regulatory submissions
• Participate in quality and LAB meetings
• Engage with regulatory agencies on meetings and submissions
• Provide consultative support to External Development clients and collaborators
• Perform duties of Laboratory Technical Supervisor as required
• Contribute to planning, budgets and forecasting
• Communicate status across departments and contribute to company goals
• Present at scientific conferences (MSACL, ASMS, HUPO)
• Other duties as assigned
• Set team strategy and performance expectations
• Drive talent development and succession planning
• Provide feedback and conduct evaluations
• Foster culture of respect and collaboration

Skills

Mentor/Develop team

Regulatory compliance

Staff management

Project leadership

Communication skills

Laboratory operations

Budgets & forecasting

CAP/CLIA compliance

Regulatory interactions

Leadership

Education

PhD or MD

Job description

Every team member at Biodesix has the potential to impact our business and our patients, providers, and partners. Even our company logo includes a “thumbprint” – a visual reminder that encourages all team members to put their fingerprints on our future. Explore our openings below and see if your next role is here with Team Biodesix. Thank you for considering us in your search.

Position:VP - Laboratory Operations

Location: De Soto, KS

Job Id:858-055501

# of Openings:1

VP - Laboratory Operations

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.

The VP, Lab Operations – Kansas will be primarily accountable for day-to-day Laboratory Operations in the Biodesix De Soto, KS Laboratory and provides oversight of the business and technical/operational functions of the Laboratory. Business functions include technical readiness and personnel support for Product Development and Services in the Clinical Laboratory.

Appropriate designees may act as responsible delegates according to the established Roles and Responsibilities, including day to day responsibilities required for CAP/CLIA and NYS CLEP, as well as all state-specific requirements in which Biodesix is an approved test facility. This position is designated as a Laboratory Supervisor and is expected to meet the applicable qualification, oversight, and responsibility requirements under 10 NYCRR Part 58, as well as the responsibilities defined in HR S4.

KEY RESPONSIBILITIES:

Either directly, or by delegation shall be responsible for:

• 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

Leadership Responsibilities

• 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

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

EDUCATION & EXPERIENCE:

PhD or MD. Must have 10 years+ of post-graduate experience with significant regulatory interactions.

Eight or more years of laboratory operations experience at a senior level

COMPENSATION & BENEFITS:

• Compensation Range$173,900 to $231,900 annually
• Discretionary Bonus opportunity
• Comprehensive health coverage: Medical, Dental, and Vision
• Insurance: Short/Long Term Disability and Life Insurance
• 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

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 proud to be an Equal Opportunity Employer

We are committed to ensuring an inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. 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.

Notice to Recruitment Agencies

In the case of candidates submitted or presented to Biodesix by a recruiter or agency without a signed agreement, Biodesix explicitly reserves the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

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