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Assoc Dir, Upstream Operations

  • Morrisville, North Carolina, United States
  • Full Time

About the Job

The Associate Director, Laboratory Operations guides operations within FMI’s high-volume Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory focusing on the delivery of Accessioning, Histology, IHC, and Specimen Return. The role supervises laboratory staff across these groups. The incumbent helps drive day to day operations that will further develop a high bar of excellence in quality and customer service. The position contributes to cross-site and cross-functional collaboration with members of other teams (e.g. Client Services, Process Engineering, Regulatory, Molecular, Technology, and Automation) as well as with vendors and other external partners.

This is a regulated position and additional information may be available from FMI Quality Assurance regarding regulatory guidelines.

Key Responsibilities

• Direct the activities of and mentor upstream laboratory team members to ensure day-to-day operations are compliant with delivery metrics, internal policies, procedures, and CLIA/CAP/FDA regulatory standards.

• Direct oversight of RTP Upstream as well as supporting additional Upstream teams in other locations

• through cross-site and cross-functional collaboration on initiatives to develop, maintain, or continuously improve policies and procedures supporting upstream testing processes.

• Ensure achievement of Key Performance Indicators (KPIs) and generate dashboards/reports summarizing productivity and process performance for presentation to senior management.

• Deploy problem-solving skills to assess and identify areas for process improvement and to solve for complex business challenges.

• Lead the planning and execution of project plans.

• Manage the talent pipeline to execute the laboratory operations staffing plan and create effective role succession.

• Staff the clinical laboratory with appropriately credentialed technical and professional employees.

• Identify resource needs and assign individual responsibilities on projects by working with managers to secure and schedule project resources.

• Lead professional development and retention efforts for team members.

• Ensure timely responses to both internal and external customer inquiries.

• Exercise judgment and decision-making authority in determining methods, techniques and evaluation criteria for obtaining business-critical results.

• Participate in internal and external collaborative partnerships and lead equipment and assay qualification and validation efforts for the introduction of new and updated products and workflows in the upstream laboratories.

• Author, contribute to, and review standard operating procedures (SOPs), tracking forms, training logs, change controls, non-conformance reports and investigations, and deviations or CAPA reports, as needed to support operational excellence.

• Maintain knowledge base of relevant fields and techniques and educate laboratory operations team members on the same.

• Represent FMI to commercial and academic partners through talks, lab tours, and tutorials.

• Position requires flexibility to work off hours, weekends, or holidays as needed.

• Other projects as assigned.


Basic Qualifications

• Bachelor’s degree in a biological or life science or equivalent

• 7+ years of relevant lab experience

• 4+ years of prior work experience in a management role

Preferred Qualifications

• Master’s degree or other advanced degree in a biological or life science

• Experience in a high-volume reference laboratory environments, preferably with a focus on oncology diagnostics

• Experience collaborating with cross-site/global teams as well as proven success influencing cross-site/global teams and initiatives

• Quality Systems Regulation (QSR) compliant lab experience

• In-depth understanding of policies, processes, and procedures necessary to perform high quality, high-complexity laboratory testing in environments regulated by CLIA and the Food and Drug Administration (FDA), as well as to deliver these services to physician customers

• Strong knowledge of laboratory operations with extensive experience in NGS-based testing

• Impeccable documentation practices and attention to detail

• Ability to prioritize and complete tasks in a timely manner

• Demonstrated self-initiative to exceed expectation and seek continuous improvement

• Proficiency utilizing Microsoft Office Suite, especially Excel and Power Point

• Excellent oral and written communication skills

• Strong organization and administrative skills

• Strong interpersonal skills that include collaboration and creative problem solving

• Understanding of HIPAA and importance of privacy of patient data

• Commitment to FMI values: patients, innovation, collaboration, and passion

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Internal applicants, please use your FMI email address.

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