Clinical Laboratory Director - Prenatal Diagnostics

Organization
Sequenom Laboratories
Job Location
3595 John Hopkins Court
San Diego, CA 92121
Salary
competitive salary, bonus, equity
Job Description

Sequenom Laboratories provides best-in-class laboratory clinical diagnostic services with a focus on prenatal testing and conditions.  Sequenom is among the largest laboratories utilizing next generation sequencing (NGS) for routine clinical use.

The Clinical Laboratory Director reviews data, approves and signs-out results for high complexity genetic and molecular laboratory developed tests on a daily basis and acts as a clinical consultant for the lab.

 

Responsibilities:

  • Reports laboratory test results for all test methods approved by CAP, NY, CA and CLIA from pre-analytical, analytical and post-analytical testing; interprets reports and patient results to ordering physicians.
  • Reviews and recommend improvements for laboratory procedures based on quality metrics and test results over time.
  • Serves as laboratory departmental liaison during government inspections and audits.
  • Assists preparing, developing and critiquing proposals to ensure complete, high quality proposal submission.
  • Ensures processes and services are monitored for quality, cost effectiveness, and efficiency through continuous process and quality improvement. Recommends and implement ideas to improve operational efficiency.
  • Ensures services are provided in accordance with state and federal regulations, lab policy, and accreditation and compliance requirements. Provide guidance to laboratory staff as required by applicable state and federal regulations.
  • Maintains current professional and best practice knowledge. Completes required continuous training and education, including department specific requirements.
  • Ensures required documentation is performed in an accurate and timely manner
  • Demonstrate understanding of safety issues specific to a CLIA environment
  • Manages staff including recruiting, hiring, motivating, performance management, training and development
Requirements
  • MD with relevant molecular pathology experience and Board Certification in clinical pathology or board-eligible, or Ph.D. in Molecular Pathology, Laboratory Science or related fields
  • Current California Lab Director accreditation for a high complexity lab with ability to approve and sign-out test results for laboratory developed tests
  • Minimum of 2 years’ experience in a CLIA-licensed genetic testing laboratory, preferable within the past 4-6 years
  • Experience working in a high complexity CLIA/CAP environment preferred
  • Knowledge of regulatory requirements for molecular diagnostic laboratory developed tests from product development to commercialization through post launch support
  • Demonstrated understanding of and experience with safety issues specific to a CLIA environment
  • Must be able to communicate effectively and provide information to senior management on the implication of policies and procedures, and to recommend specific actions
  • Analytical and strong problem solving skills.
  • New York State Certificate of Qualification in relevant specialty areas a plus

 

Sequenom is an EOE - Minority/Female/Disability/Vets

 

 

How to Apply

To apply, please visit http://www.sequenom.com/Careers/Jobs 

About Our Organization

Sequenom Laboratories, a wholly-owned subsidiary of Sequenom, Inc., is a CAP accredited and CLIA-certified molecular diagnostics laboratory, dedicated to the development and commercialization of laboratory-developed tests (LDTs) for prenatal diseases and conditions. Sequenom holds or has access to intellectual property for noninvasive prenatal testing using circulating cell-free fetal nucleic acids.

 

As a life sciences company, Sequenom (NASDAQ: SQNM) has a guiding vision: To enable healthier lives as the premier provider of innovative genetic information with an exceptional customer experience
What makes this vision a reality? Our deep commitment to "Quality of Science." For us, only the highest quality is acceptable. Sequenom team members thrive in a "science first" environment where ideas and innovation are part of daily life. This is your opportunity to work on cutting-edge science that is revolutionizing patient care.

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