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Associate Clinical Laboratory Director (Molecular)
Ref No.: 17-00271
Category: Biotechnology
Location: New Brunswick, New Jersey
We are seeking an Associate Clinical Laboratory Director to report to the Clinical Laboratory Director and to join our growing team. In partnership with the Clinical Laboratory Director and Clinical Laboratory Supervisor, you will be responsible for the implementation of the Quality Management System of the laboratory that meets CLIA IQCP and CAP guidelines.

Responsibilities:
  • Coordinate with the Clinical Laboratory Director, senior management and cross functional teams to plan and pipeline current, and new, test development.
  • Oversee verification and validation of all new test development and work with Clinical Laboratory Director on achieving CLIA laboratory developed test approval.
  • Provide overall operation and administration of the laboratory, including oversight of management of personnel.
  • Make sure all laboratory tests are being performed in accordance with the Standard Operating Protocols.
  • Oversee and maintain Quality Management System of the laboratory.
  • Manage and oversee proficiency testing programs.
  • Ensure that the quality control and quality assessment programs are well established and maintained in the laboratory to meet all CLIA and CAP requirements.
  • Oversee CLIA/CAP inspection and maintain CLIA/CAP laboratory license.
  • Ensure testing systems developed in the laboratory provide quality services for all aspects of the test which include pre-analytic, analytic and post analytic phases of testing.
  • Ensure that lab personnel are performing the test methods as required for accurate and reliable results and are tested for competency of all test run.
  • Document all corrective actions taken when test systems deviate from the laboratory's established performance specifications.
  • Be a proactive leader and identify opportunities and propose improvements, efficiencies and operational modification as it relates to the laboratory.
  • Work closely with the Clinical Laboratory Director on all day-to-day operations of the laboratory as listed above.

Qualifications:
  • PhD in biologic sciences with appropriate experience in molecular genetics methods.
  • Preferred minimum 2 year of professional experience in a CLIA/CAP certified laboratory post PhD training.
  • Preferred board certification in one of the following: ABMGG, AAB as a HCLD or CLIA excepted board certification with molecular genetics laboratory experience.
  • Experienced in the field under the direct supervision of a qualified director, and, for laboratories subject to US regulations, qualified to perform high complexity testing.
  • Strong knowledge of NGS technology.
  • Proven experience in working with NGS technology.
  • Strong knowledge of Molecular Biology and Genetics.
  • Strong written and verbal communication, collaboration and interpersonal skills.
  • Able to effectively interact with all levels of technical and non-technical staff.
  • Strong problem-solving skills and willingness to roll up one's sleeves to get the job.
  • Experience with Microsoft Office Suite and Google tools.
  • Eligible to apply or holds a New York State Certification Qualification License in Genetic Testing. (PREFERRED)
  • Experience in Women's Infertility and Reproductive Sciences. (PREFERRED)