Oxford Immunotec, Inc.

  • Technical Lab Director

    Job Location US-MA-Norwood
    Posted Date 1 week ago(1 week ago)
    ID
    2018-1949
    # of Openings
    1
    Department
    Laboratory
  • Overview

    The Technical Director is responsible for the overall technical validity and performance of diagnostic assays performed in our Norwood, MA and Memphis, TN laboratories. In combination, these two sites operate 365 days/year to perform 20+ unique assays in the diagnosis of Tick-Borne Diseases and TB. The Technical Director will collaborate with the Medical Directors and laboratory management at both sites to ensure the accurate and reliable reporting of patient results. This position will also provide leadership in the development and technical transfer of assays and technologies from R&D to Operations. The Technical Director will also be responsible for the application and renewal of state and other regulatory licenses and certifications. This position requires unwavering commitment to providing the highest quality patient care.

    Responsibilities

    • Leverage relevant experience and strong technical skills in Serology, Immunology, and/or Molecular Biology to provide the Norwood and Memphis laboratories with technical guidance and support
    • Represent Operations on client calls and project teams as a technical subject matter expert on all or most of the company’s laboratory procedures
    • Collaborate with R&D and Commercial to develop and transfer next-generation assays and technologies to the patient testing laboratories. This includes the development and execution of validation protocols
    • Collaborate with the Manufacturing and QC department to develop improved methods for the tracking and quality control of critical reagents
    • Own responsibility for ensuring that assays are performed in a consistent and standard way across sites, and authorize any recommended variations in protocol between sites
    • Evaluate and improve assay performance through the development and validation of process improvements designed to increasing the quality, robustness, and overall performance of laboratory procedures
    • Perform routine audits of laboratory assay and reporting procedures and SOPs to ensure the accuracy and quality of patient results. Evaluate laboratory personnel compliance to SOPs, identifying re-training or SOP improvement opportunities
    • Oversee the routine training and competencies of laboratory personnel through scheduled or investigatory assessments
    • Respond to technical inquiries from clients and field sales team members
    • Provide direct supervision for the Cross-Functional team, a group of technologists focused on tech transfer, process development, troubleshooting assays, and providing flexible staffing option for the clinical lab
    • Coach and mentor team members, providing them the support and tools to be successful and grow with the company
    • Perform required supervisory tasks including the selection, evaluation, promotion, performance management, and termination of personnel
    • Identify metrics and leading KPIs designed to alert laboratory of out-of-control data and other trending quality data requiring action. Apply similar metrics to baseline new assays or reagents and report on performance. Promote a culture that supports making data-driven decisions and acting on information proactively
    • Provide expertise on lab regulations and compliance. This includes the timely application and renewal of licensure with all relevant regulatory agencies for Memphis and Norwood laboratories
    • Provide consultation on issues related to laboratory compliance with CLIA, CAP, FDA, and state regulations
    • Ensure compliance with regulatory standards, laws and requirements of requisite agencies by employing appropriate systems/processes

    Qualifications

    • Bachelor’s degree in a scientific discipline is required, with 10+ years of relevant experience; a Master’s degree or PhD is preferred
    • Education and expertise in Serology or Immunology is highly desired. A background in Molecular Biology will also be considered
    • Experience supervising technical personnel, ideally in a clinical laboratory environment
    • Demonstrated experience performing or developing serological and molecular assays is required
    • Experience working in a clinical diagnostics laboratory, under CAP and CLIA regulations, is required. Experience performing tasks related directly to QA or Regulatory is preferred
    • Experience in assay development, process development, and/or tech transfer is highly desired.
    • Ability to work independently and demonstrate a high degree of personal & professional initiative
    • Ability to create cross-functional teams driven by project/business needs; ability to lead teams and secure outcomes without direct line authority
    • Strong organizational/time management skills; able to manage multiple competing priorities simultaneously
    • Demonstrates the highest level of ethics and integrity
    • Excellent verbal, presentation, and written communication skills
    • 15-20% travel required

    PHYSICAL DEMANDS: 

    The physical demands described within the Position Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile.  The employee is also required to interact with a computer, and communicate with peers and co-workers. Job requires employee to walk considerable distances in the facility during the course of his or her work. 

     

     

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