Clinical Laboratory Director (North Brunswick, NJ Laboratory)

Organization
Celmatix Inc.
Job Location
North Brunswick, NJ 08902
Benefits

Celmatix is looking to add talented and accomplished individuals to its fast-growing team. We offer a full range of benefits including competitive compensation, excellent medical insurance, pre-tax FSA and transit benefits, and a 401k retirement plan.

Job Description

Celmatix is a research-driven precision medicine company focused on maximizing fertility. The Clinical Laboratory Director oversees all clinical lab operations and ensures that all complex molecular diagnostic assays and systems are performed under appropriate CLIA compliance and regulatory requirements. 

The ideal candidate is a strong written and verbal communicator. The ideal candidate is highly collaborative with a roll up your sleeves attitude. Detail-oriented, efficient and motivated, this candidate is a conceptual thinker that has experience working in a fast-paced, dynamic environment.

Essential Duties and Responsibilities:

  • Responsible for technical and administrative oversight of laboratory staff and day-to-day operations within the laboratory.
  • Ensure regulatory agency compliance including, CLIA, NYS, and CAP.
  • Provide oversight of all aspects of the laboratory’s quality management system to ensure conformance to requirements described in the laboratory’s quality manual.
  • Provide effective and efficient administrative direction of the laboratory, including budget planning and controls in conjunction with the individual(s) responsible for financial management of the laboratory.
  • Ensure that sufficient qualified personnel are employed with documented training and/or experience to supervise and perform the work of the laboratory.
  • Provide educational direction to laboratory staff.
  • Ensure that policies and procedures are established for monitoring staff to assess competency and whenever necessary, to provide remedial training or continuing education to improve skills.
  • Specify in writing the responsibilities and duties of all laboratory personnel, including assistant directors.
  • Maintain a safe working environment by strict adherence to company safety policies and procedures, remain alert to safety hazards and address unsafe conditions.
  • Make sure the physical environment for employees is safe from physical, chemical and biological hazards while following safety and biohazard regulations.
  • Ensure that an approved procedure manual is available to all personnel.
  • Monitor all work performed in the laboratory to ensure that medically reliable data are generated.
  • Assure that the laboratory participates in monitoring and evaluating the quality and appropriateness of services rendered, within the context of the Quality Management System, regardless of where the testing is performed.
  • Provide advice to referring physicians regarding the significance of laboratory findings and ensure that reports of test results include pertinent information required for specific patient interpretation.
  • Ensure that the laboratory is enrolled in the department’s proficiency testing program for the testing performed and that the laboratory adheres to the program’s administrative and technical requirements.
  • Select all reference laboratories.
  • Maintain an effective working relationship with applicable accrediting and regulatory agencies, administrative officials, and the medical community.
Requirements

Qualifications:

  • PhD or MD, concentration in pathology, molecular pathology and/or genetics preferred.
  • 4+ years post-graduation full-time general lab training.
  • Minimum 2 years spent in acquiring proficiency in Molecular Genetics in an approved clinical lab.
  • Certified in American Board of Bioanalysis (ABB), American Board of Medical Genetics and Genomics (ABMGG) or other national accrediting board acceptable to the Dept. of Health (DOH).
  • Prior experience desired in management of laboratory business, including such areas as personnel management, operations, client services, specimen processing, total quality management, and technical service.
  • Experience with next-gen sequencing preferred.
  • 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.
About Our Organization

About Celmatix

Named one of Crain's "Biotechs to Watch," Celmatix is changing the face of women’s health through the development of digital tools and genetic insights focused on fertility potential. Our unique approach combines data science and genomics to bring personalized medicine to fertility. Our leadership team includes a diverse group of world-class scientists and professionals including a founder recently recognized by Fortune Magazine as one of 15 Entrepreneurs Disrupting their Industries, Inc Magazine’s 10 Women to Watch in Tech, and named an Aspen Institute’s Health Innovator Fellow, and a NYC Venture Fellow by the NYCEDC.

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