About Foundation Medicine
Foundation Medicine is leading a transformation in cancer care, where each patient’s treatment is informed by a deep understanding of the molecular changes that contribute to their disease. As a molecular information company, we are focused on fundamentally changing the way in which patients with cancer are treated. Our products provide more than information. They offer hope to patients, their families and friends, their physicians and caregivers.
As a member of the Foundation Medicine team you’ll work with everyone fighting the disease patients and their families, payers, physicians, drug developers to raise awareness about this transformation in cancer care and Foundation Medicine’s role to ensure we’re delivering the tools and information they need to make an impact and drive access for patients everywhere. Foundation Medicine is headquartered in the heart of Cambridge, MA. Since October 2017, FMI Germany GmbH in Penzberg has been actively supporting this mission.
Foundation Medicine is seeking to add a Director, Laboratory Operations to its rapidly growing team in Penzberg, Germany.
Main responsibilities cover:
· Manage the Laboratory Operations department including the diagnostics team, the reagent QC and materials management team as well as product improvement and product transfer team
· Ensure the Foundation Medicine laboratory conducts diagnostic procedures in accordance with local regulations and company policies and procedures
· Transfer/establish and validate new assays for clinical operations according to ISO 15189 standards including generation of validation plans and reports
· Work with Quality Assurance to review, manage, and improve, where necessary
· Maintenance and continual improvement of the Laboratory Operations workflow and FMI products
· Prepare and review operational metrics and other data for executive management on a regular basis
· Staffing the team with appropriately credential technical and professional employees
· Lead professional development and retention efforts for team members
· Develop, plan and recommend budget, capital equipment, and staffing changes to accommodate a rapidly growing highly esoteric testing business as required
· Work with management team on short and long term strategic planning for the clinical lab operations for existing and new products
· Work in close alignment and build strong relationships with our FMI-colleagues in Cambridge and North Carolina
· Maintains extensive knowledge of relevant fields and techniques.
· Position requires ability to travel internationally (up to 20%).
· Other duties as assigned by manager.
Education and Experience:
· M.Sc. or PhD in relevant biological services
· 5+ years’ working experience in a laboratory operations environment with prior experience in high throughput molecular cancer diagnostics using Illumina Next-generation sequencing technology
· Strong experience in people management with 3+ years’ experience managing a team of 10+ people
· In-depth understanding of policies, processes, and procedures necessary to perform high quality, high complexity laboratory testing in ISO 15189 regulated environments
· Ability to communicate professionally across a variety of stakeholders, provide information to management on the implication of policies and procedures, and to recommend specific actions
· Ability to bring innovative thinking and ideas to solve problems and improve any and all phases of laboratory operations
· Must be detail oriented with excellent prioritization and organizational skills
· Must be able to provide results on schedule in a fast-paced, dynamic environment
· Business acumen to balance highest quality standards with timely delivery of results to patients
· Excellent leadership, human relations and communication skills
· High attention to detail and the ability to multi task and adapt rapidly to changing priorities
· Must be fluent in German and English
Internal applicants, please use your FMI email address.