GeneDx

Lead, Laboratory Process Improvement - Hybrid

GeneDx

full-time

Posted on:

Origin:  • 🇺🇸 United States

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Salary

💰 $114,789 - $153,052 per year

Job Level

Senior

About the role

  • GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visithttps://www.genedx.com/.\n
  • The Process Improvement Lead provides technical, scientific, and/or clinical leadership in process improvement projects, working across wet and dry lab functions to develop and refine workflows, enhance efficiency, ensure quality compliance, and support validation efforts.\n
  • Lead and execute strategic process improvement initiatives across functions\n
  • Analyze complex production workflows and identify opportunities for optimization\n
  • Coordinate cross-functional teams to develop and validate new workflows\n
  • Provide advanced troubleshooting and problem-solving for technical issues\n
  • Lead and execute protocol development, execution, validation, and documentation\n
  • Ensure compliance with regulatory standards\n
  • Mentor and train junior associates within the department\n
  • Support and train personnel in process improvement and/or new process workflows\n
  • Performs other duties assigned in support of the team or department\n
  • If applicable, may fulfill the responsibilities of Clinical Consultant as defined by CLIA, with respect to one or more type of testing at GeneDx. Specifically: provide consultation to the laboratory's clients; assist in ensuring that appropriate tests are ordered to meet the clinical expectations; ensure that reports of test results include pertinent information required for specific patient interpretation; ensure that consultation is available and communicated to the laboratory's clients on matters related to the quality of the test results reported and their interpretation concerning specific patient conditions\n
  • People Manager\n
  • This position may directly supervise non-supervisory employees. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.\n
  • Education, Experience, and Skills\n
  • Bachelor’s or Master’s degree in Molecular Biology, Genetics, Biotechnology, Genetic Counseling or a related field; PhD in Biology, Genetics or related field; MD or DO with experience in human genetics.\n
  • 6+ years of experience in a laboratory or process improvement setting\n
  • Strong experience in process validation, regulatory compliance, and quality systems\n
  • Experience with New York State-licensed laboratory preferred\n
  • Proven ability to lead cross-functional teams and drive efficiency improvements\n
  • Familiarity with Lean Six Sigma or similar methodologies is preferred\n
  • Certificates, Licenses, Registrations\n
  • Either ABMGG Diplomate or equivalent, certified in at least one specialty, or Certification by the American Board of Genetic Counseling (ABGC) or equivalent is required for relevant positions\n
  • For Genetic Counselors: Licensure is required in the state where the employee works, if applicable. Genetic counseling licenses for additional states may be required at the discretion of GeneDx\n
  • Physical Demands\n
  • 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. While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds.\n
  • Work Environment \n
  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet.\n
  • #LI-REMOTE\n
  • Pay Transparency, Budgeted Range\n\n"

Requirements

  • Bachelor’s or Master’s degree in Molecular Biology, Genetics, Biotechnology, Genetic Counseling or a related field; PhD in Biology, Genetics or related field; MD or DO with experience in human genetics.\n
  • 6+ years of experience in a laboratory or process improvement setting\n
  • Strong experience in process validation, regulatory compliance, and quality systems\n
  • Experience with New York State-licensed laboratory preferred\n
  • Proven ability to lead cross-functional teams and drive efficiency improvements\n
  • Familiarity with Lean Six Sigma or similar methodologies is preferred