Laboratory Director, Clinical Molecular Diagnostics

April 30, 2018
Baltimore, Maryland


Overview:

PapGene, Inc. is a Baltimore-based molecular diagnostics company commercializing high-complexity laboratory developed tests (LDTs) for cancer diagnostics. PapGene’s core technology uses innovative massively parallel sequencing (MPS) techniques invented by world-leading cancer researchers at Johns Hopkins University.

PapGene is seeking a part-time or full-time Laboratory Director with Clinical Molecular Diagnostics experience to join our growing team.

Essential Duties:

The Laboratory Director will oversee the overall operation and administration of the laboratory, ensuring that the clinical laboratory meets state and federal regulations.

The Laboratory Director will oversee lab personnel to ensure they perform test procedures accurately and proficiently.

The Laboratory Director will be available to provide on-site, telephonic or electronic consultation as needed.

Specific Responsibilities:

  • Review, interpret and report patient results reliably, accurately and with integrity.
  • Make clinical decisions and provide clinical consultations to health care professionals.
  • Interact collaboratively with other laboratory staff and teams across the organization.
  • Provide oversight for quality control and quality assurance as appropriate, including setting quality standards for new tests and procedures and participating in proficiency testing.
  • Ensure the laboratory remains in compliance with applicable federal, state and local regulations, as well as adheres to applicable professional guidelines.
  • Participate in new test development and validation as needed.

    Requirements:

    • Meets applicable CLIA requirements (CFR 493.1443) for clinical Laboratory Director and state licensing qualifications where applicable.
    • Experience with high-complexity, qualitative and quantitative LDTs.
    • Experience with next-generation sequencing (NGS) technologies and result interpretation is preferred.

    To be considered for this position, please forward a copy of your resume to hr@papgeneinc.com and include a cover letter explaining why you think your background is a good fit for this job description.

    © 2017 PapGene, Inc.



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