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Job: Director, Laboratory Operations, Foundation Medicine, Morrisville, NC
Director, Laboratory Operations
Morrisville, NC 27560 United States
Foundation Medicine is dedicated to helping bring personalized cancer medicine into routine clinical practice. Harnessing advanced technology, Foundation Medicine is developing clinical laboratory tests that will broadly capture the most relevant tumor genomic and other molecular information in a single test, and connect it with relevant scientific and medical knowledge to help oncologists determine the right treatment for each patient.
The Clinical Laboratory Director will be based at our rapidly growing Morrrisville, NC facility and will report to the VP, Laboratory Operations. S/he will be responsible for managing Laboratory Operations in NC focused on next generation sequencing based oncology diagnostic testing and consultative services to hospitals, pathology and oncology groups, reference labs and biopharmaceutical clients. The selected individual will have extensive experience in high volume reference laboratory environments, preferably with a focus on oncology diagnostics, with strong acumen for program management and process improvement, to help drive strategic initiatives that will further develop a “high bar of excellence” in quality and customer service.
Primary Responsibilities and Essential Duties:
• Daily oversight of clinical molecular diagnostic laboratory performing NGS and IHC-based methodologies.
• Staffing the clinical laboratory with appropriately credentialed technical and professional employees.
• Participate in oversight for quality control and quality assurance for existing and new tests, including proficiency testing.
• Establishing, monitoring and publishing appropriate service metrics for customer satisfaction and business goals.
• Providing timely responses and support for customer requests, resolution of complaints, and investigation and resolution of laboratory test issues.
• Maintain familiarity with company SOPs, practices, and applicable professional, federal, state, and local regulations, and ensure that the laboratory is in compliance.
• Maintains extensive knowledge of relevant fields and techniques.
• Mentors other Technical Leaders.
• Advises senior management on complex technology issues and on optimizing business practices.
• Attends scientific conferences and represents business externally to commercial and academic partners through talks, tutorials, publications.
• Represents RTP Laboratory Operations department to other sites and functions for cross-site collaborations, projects and implementation of best practices.
Required Experience and Skills:
• MS or PhD in relevant biological science.
• 5+ years of experience as a Laboratory Director or Associate Laboratory Director in a high throughput genomics laboratory.
• Experience with oncology diagnostics is preferred.
• In-depth understanding of policies, processes, and procedures necessary to perform high quality, high-complexity laboratory testing in FDA and CLIA regulatory environments and to deliver these services to physician customers.
• Must be able to communicate effectively and provide information to senior management on the implication of policies and procedures, and to recommend specific actions.
• Ability to set, monitor and publish results on quality, service, and cost goals.
• Ability to bring innovative thinking and ideas to solve problems and improve any and all phases of laboratory operations .
• Comfortable in a fast-paced, dynamic team environment.
• Excellent leadership, human relations and communication skills.
• High attention to detail and the ability to multi-task and adapt rapidly to changing priorities and tasks.
Apply Here: http://www.Click2Apply.net/55fkh4rd2wjgytvp
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