Morrisville | North Carolina | United States
Foundation Medicine, Inc. (FMI) began with an idea—to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.
ABOUT THE JOB
Associate Director, Laboratory Operations leverages extensive experience in high volume reference laboratory environments to help drive strategic initiatives that further develop a “high bar of excellence” in quality and customer service. The position is responsible for oversight of the molecular testing laboratory and for cross-site and cross-functional collaboration with members of client services, laboratory operations, process engineering, quality and regulatory teams as well as with vendors and other external partners. Associate Director, Laboratory Operations requires working in the presence of chemicals and regents.
Direct the activities of and mentor molecular laboratory personnel to ensure day-to-day operations are in compliance with internal policies, procedures, and CLIA/CAP/FDA regulatory standards.
Collaborate cross-site and cross-functionally on initiatives to develop and maintain policies and procedures guiding molecular testing processes and supporting operational excellence.
Ensure achievement of Key Performance Indicators and generate dashboards/reports summarizing productivity and process performance for presentation to senior management.
Exercise judgment and decision making authority in determining methods, techniques and evaluation criteria for obtaining business-critical results.
Deploy superior 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.
Hire and lead motivation, retention and professional development efforts for team associates to effectively fulfill the mission of Foundation Medicine.
Manage the talent pipeline to execute the laboratory operations plan and create effective leadership succession.
Identify resource needs and assign individual responsibilities on projects by working with area managers to secure and schedule project resources.
Ensure timely responses to patient or physician inquiries.
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 molecular laboratory.
Author, contribute to and/or review standard operating procedures (SOPs), tracking forms, training logs, change controls, non-conformance reports and investigations, deviations or CAPA reports as needed to support operational excellence for clinical and biopharma clients.
Maintain extensive knowledge of relevant fields and techniques.
Attend scientific conferences and represent the business externally to commercial and academic partners through talks, tutorials, publications.
Other projects as periodically assigned.
Master’s Degree in a biological or life science
7+ years of relevant molecular lab experience, 3+ of which were spent in a management role preferably in cancer diagnostics or in an oncology setting
Experience with Laboratory Information Management Systems (LIMS)
Experience leading projects and process improvements
Ph.D in Biological or Life Science
Strong knowledge of laboratory operations with extensive experience in NGS-based testing
Quality Systems Regulation (QSR) compliant lab experience
Experience collaborating with cross-site/global teams as well as proven success influencing cross-site/global teams and initiatives
Experience leading the systematic optimization and troubleshooting of complex laboratory operational workflows
Experience with budgeting and capacity modeling
Experience leading LEAN /Six Sigma initiatives and teams
Experience with oversight of Reagent Quality Control (QC) processes
Self-driven to exceed expectation and seek continuous improvement
Proficiency utilizing Microsoft Office Suite, especially Excel and Power Point
Ability to work independently as well as collaborate with peers in a fast-paced and cross-functional results-oriented team environment
Ability to work within tight timelines for successful and timely execution of project and program goals
Well organized, strong administrative skills
Excellent oral and written communication skills
Understanding of HIPAA and importance of privacy of patient data
Proven experience mentoring and developing staff at all levels
Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI’s EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)