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Are you ready to be a hands-on operational leader tasked with first building, and then overseeing all laboratory initiatives and operations for brand-new genomics and anatomic pathology facility?
Do you want to work for a firm that already has a market-leading position in testing and is now leveraging its expertise in the area of Sequencing and Oncology in particular?
Do you have what it takes to move a strategy to reality, and play a significant role in developing both the infrastructure and the corporate culture for the new organization?
Do you have the prior knowledge and experience to ensure the new facility is fully compliant, operates to the highest standards, and delivers market-leading solutions to clients?
Have you been looking for the opportunity to apply your industry knowledge towards building out a lab that is going to truly achieve the “gold standard” of integration between Standards and Care and Biopharma?
Are you ready to work closely with the parent company, its leadership, and the entire team from top to bottom, to chart a new course and realize the rewards associated with this exciting new endeavor?

If your answer to these questions is an emphatic “yes” and you are ready to help lead an established segment leader, with an exceptional reputation in diagnostic testing drives a strategic expansion into genomic sequencing for Oncology, we need to hear from you.

@Orchard LLC has been asked to assist a firm already known for exceptional capabilities in the areas of diagnostic testing as they embark on a new venture and expansion. Our client has created a new Biosciences Division and is building a state-of-the-art lab in New Jersey to provide specialized genomic and anatomic pathology contract services for biopharma as well as for standard of care patient testing. The services provided will assist in the research, development, and commercialization of new products for companies in the pharmaceutical and biotechnology space, with an emphasis on Oncology. Step one is to build the leadership team for the new facility, including the critical role of the Operations Director. If you have ever wanted to put your technical and leadership skills to the test, in an environment where your ideas and concepts will be given free rein, then this is just the role you have been waiting for.

As the Director of Operations you will;

  • Oversee and coordinate all laboratory initiatives and operations related to building our client’s New Jersey-based laboratory operations.
  • As important as the build-out of the infrastructure will be the development of an exceptional corporate culture at the new location.
  • The Director of Operations will play a vital role in both the tactical and cultural development of the facility while working in close partnership with executive management on a day-to-day as well as strategic initiatives.

Some of your responsibilities include;

  • Planning, developing, organizing, implementing, directing, and evaluating the organization’s laboratory operations and performance.
  • Responsibility for the overall operation and administration of the laboratory, including the employment of competent lab personnel.
  • Ensuring that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and post-analytic phases of testing.
  • Ensuring that the physical plant and environment conditions of the laboratory are appropriate for the testing performed and provide a safe work environment.
  • Ensuring that the test methodologies selected have the capability of providing the quality of results required for patient care; meet accuracy standards, and lab personnel is using test methods for accurate and reliable results.
  • Ensuring that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed and that the proficiency testing samples are tested as required by CLIA and to meet all CLIA requirements including lab personnel requirements.
  • Establishing and maintaining quality control and quality assurance programs to assure the quality of laboratory services provided and to identify failures in quality as they occur.
  • Ensuring the establishment and maintenance of acceptable levels of analytical performance for each test system.
  • Ensuring that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory’s established performance specifications are identified and that patient test results are reported only when the system is functioning properly.
  • Ensuring that reports of test results include pertinent information required for interpretation.
  • Ensuring that consultation is available to the laboratory’s clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions.
  • Ensuring that prior to testing patients’ specimens, all personnel has the appropriate education, experience, and training. Identify needs for continuing education or remedial training if needed. Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process.
  • Establishing operations standards for cost control, waste reduction, quality, safety, and complete on-time delivery.
  • Overseeing the development of the organization’s plans and programs in the evaluation of long-range planning and regulatory action on operational performance. Foster a unified culture and promotes a process for collaboration, cooperation, sharing of information, and mutual teamwork.
  • Monitoring utilization patterns of lab services and advising Leadership and other appropriate staff on developing trends in clinical service needs.
  • Ensuring operational adherence to currently accepted technical service standards for laboratory medicine.
  • Ensuring operational adherence to applicable policies and procedures by all technical and operational staff.
  • Participating in the development and implementation of operations budget to ensure compliance with organizational expenditure requirements.
  • Advising, negotiating, managing, and administering all contracts into which the lab may enter.
  • Leading and directing the development, communication, and implementation of effective growth strategies and processes.
  • Performing other responsibilities as mandated by Clinical Laboratory Improvement Amendments (CLIA) and any other pertinent local, state, or federal regulations.
  • Performing other duties as required.

Your background will include;

  • Bachelor’s degree in Biology, Clinical Laboratory Technology, or related field. A Master’s Degree is preferred
  • ASCP Med Tech License is desired.
  • Certification in anatomic or clinical pathology, or both, by the American Board of Pathology.
  • Minimum 5 years of senior management experience within a central laboratory overseeing day-to-day operations.
  • Knowledge of academic medical settings and a proven track record of successfully working in such settings.
  • Examples where you have demonstrated strategic vision and technical, analytical sound operational focus to meet significant challenges, in particular those related to growing an organization.
  • A commitment to being a team player who can relate to people at all levels of the organization.