Director, Operational Systems
1 month ago
About the Job
The Director of Operational Systems plays a key role in a new chapter of our organization, overseeing the implementation and validation of lab automation while leading various technical and operational aspects. This individual will work closely with the Director of Lab Operations to ensure seamless technical transfer of assays, manage outsourcing processes, and maintain compliance standards. The Director of Operational Systems is responsible for driving automation initiatives within the laboratory setting. This role requires a strategic mindset, strong leadership skills, and a dedication to maintaining operational efficiency and compliance. The ideal candidate will collaborate with cross-functional teams and external partners to ensure the smooth execution of lab processes and maintenance of high-quality standards.
The incumbent of this specific role is joining a new and rapidly growing team and will be given the opportunity to support the strategic decision making, team structure and test implementation from scratch. Titles are internal to Foundation Medicine and may not align with Clinical Regulations.
This is a regulated position and additional information may be available from FMI Quality Assurance regarding regulatory guidelines.
Regular onsite work at a designated FMI location is an essential function of this role.
Key Responsibilities
Implement and validate lab automation solutions to enhance operational efficiency. Lead the technical transfer of assays from assay development in collaboration with the Director of Lab Operations. Manage outsourcing of processes outside of core competency and oversee outsourced activities to ensure quality standards are met. Oversee inventory management, incoming goods qualification, and maintain supplier relationships. Supervise equipment maintenance, quality control, and repair processes to ensure uninterrupted operations. Always ensure audit readiness and compliance with regulatory standards in collaboration with the Director of Lab Operations. Build and lead a high-performing team that aligns with the company’s values and strategic goals. Create and maintain interdisciplinary networks and collaborations to drive innovation and efficiency. Leverage a deep understanding of the process in troubleshooting assays and instrumentation as needed. Provide training, competency evaluation, protocol compliance management and annual proficiency benchmarking of all laboratory personnel. Participate on cross-functional teams to coordinate troubleshooting and process improvements, and/or implement new workflows or products. Represent the laboratory operations department at cross-functional meetings or to guests as needed. Titles are internal to Foundation Medicine and may not align with Clinical Regulations.Qualifications
Basic Qualifications
Bachelor’s of Science Degree in a chemical, physical or biological science, or medical technology and 10+ years of experience in a molecular clinical laboratory (CLIA/CAP); OR Masters’ of Science Degree in Chemical, Physical or Biological Science or MBA and 8+ years of experience in a molecular clinical laboratory (CLIA/CAP), at least 2 of which have been spent working under the direction of a doctoral level supervisor Certifications or licensure that is required by the state or country in which the job is posted 5+ years of leadership experiencePreferred Qualifications
Ability to adapt to changing procedures, tasks and a fast growing team Ability to deliver results on schedule in a fast -paced, dynamic environment Ability to work well under pressure while maintaining a professional demeanor Ability to prioritize and thoroughly follow up on assigned tasks Strong experience working in QSR compliant lab or other regulated laboratory environment Knowledge and experience working with DNA manipulation techniques, enzymatic reactions, and sequencing chemistry, protein experience is a plus Experience with ensuring and maintaining integrity and quality of a lab in compliance with QMS Experience with a Laboratory Information Management System (LIMS) Demonstrated history working as a leader within a team Knowledge of accreditation and regulatory standards Knowledge of laboratory safety protocols Familiarity with high through-put platforms and common molecular laboratory equipment (pipettes, thermocyclers, liquid handlers, etc.) Proficiency utilizing Microsoft Office Suite and google tools and switching between platforms Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues Excellent organization and attention to detail Understanding of HIPAA and importance of privacy of patient data Commitment to FMI values: patients, innovation, collaboration, and passion#LI-Onsite
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