Job Description

Direct, plan, and manage the scientific/medical quality of the technical department in the field of Infectious Diseases (or an expert in Molecular Biology or Microbiology). Works with scientist(s) and medical laboratory scientists on the development and optimization of clinical assays. Provides expert advice to management and technical personnel regarding development technologies and activities. Is accountable for quality and timeliness of projects involving themselves or colleagues and demonstrates exceptional scientific creativity and vision. This person is ultimately responsible for developing information that extends scientific knowledge in the field of Infectious Diseases.

Responsibilities

• Direct, plan and manage Infectious Diseases activities of scientists for feasibility studies, new product development, modifications and improvements of assays, new and modified testing platforms, assay troubleshooting, and product launch.
• Ensures that proficiency testing program is conducted in a timely manner, reviewed by appropriate staff, and approve of corrective action when a proficiency testing result is found to be unsatisfactory.
• Monitors quality control to ensure that acceptable levels of analytical performance are maintained for each test system. Ensures that patient test results are reported only when the system is functioning properly.
• Work with clinical laboratory operation staff to ensure that assays are performing as expected and laboratory practice meets CLIA, CAP and State regulatory requirements.
• Provide expert advice to executive leadership and technical personnel regarding development technologies and activities.
• Provide inputs for new research developments in the appropriate fields of Infectious Diseases, making recommendations on tests to develop that are consistent with mandates from the Chief Medical Officer, Clinical Franchises, and/or other internal business lines.
• Attend Subspecialty Team meetings and other senior laboratory management staff meetings. Participates in all significant scientific, business and policy decisions impacting the clinical utility and quality of testing services.
• Provide and participate in educational programs for Quest’s medical and laboratory staff.
• Provides clinical consultation to clients of the laboratory.
• Participates in continuous improvement utilizing the LeanThinking.
• Directs the on-going research and development of new assays, troubleshooting and/or improvements of current assays.
• Serves as Quest Diagnostics representative to the scientific community via services, publications, presentations, etc.
• Teaching didactics to the Pathology residents and Medical Technologists/Students in training.
• Participation in industry sponsored 510k/PMA submissions for investigative devices and assays in Principal Investigator capacity.

Qualifications

Required Work Experience:

• Ph.D. in Molecular Biology, Microbiology or equivalent is required.
• Typically requires at least 2 years of work experience inclusive of postdoctoral fellowship.

Physical and Mental Requirements:

• The physical demands described here 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.
• Most duties are performed while sitting at a desk, (i.e., operating a computer or typewriter, using a telephone, or writing and analyzing data and/or reports). Walking or standing within the office area may be required for the operation of other office equipment and for meetings. Occasionally duties are performed while standing or sitting in a laboratory and may require manual dexterity and visual acuity in the operation of equipment. Some operations include the use of chemicals that requires following safe handling procedures. While performing the duties of this job, the employee is frequently required to use hands to finger, handle or feel objects, tools or controls and reach with hands and arms; in the operation of equipment or instruments located in the work environment. The employee is frequently required to sit and occasionally required to stand, walk, and stoop. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close and distance vision, ability to distinguish color, and depth perception.

Knowledge:

• Able to lead projects and programs, set standards, and train staff.
• Experience in managing technical professionals required; with demonstrated supervisory and leadership abilities.
• Develop staff to independently solve technical problems; must act as a lead source of product development knowledge in the business unit.
• Understands the diagnostics product development process and design controls under FDA Quality System Regulations for medical devices.
• Able to resolve conflicts at both the project team and management level.
• Familiarity with clinical laboratory practices and operations is desirable

Skills:

• Must possess excellent command of the English language and grammar, with demonstrated proficiency in written and oral communications.
• Ability to understand and critically analyze internal product development documents and business presentations, general business periodicals, relevant technical journals, and applicable governmental regulations.
• Ability to write clear, concise reports and business correspondence.
• Ability to effectively present information and respond to common inquiries or complaints from employees, executives, vendors, customers, regulatory agencies, or members of the scientific community.
• Ability to compute basic statistical measures associated with quality control functions.
• Ability to work with mathematical concepts such as probability and statistical inference, linear algebra, and curve fitting at a sufficient level to guide staff and assess the quality of departmental work.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to analyze an extensive variety of business and technical information, make appropriate assumptions, and understand the implications of both the data limitations and assumptions on the conclusions drawn.
• Ability to effectively analyze and challenge data and conclusions generated by others.

Education

• Doctorate Degree Requires knowledge and skills normally acquired through the successful completion of a Ph.D. in a scientific field, or equivalent combination of education and experience (Required)
• D(ABMM) certification or eligibility preferred.

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