Technical Operations Subject Matter Expert

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 visit www.genedx.com. 

Summary 
The Technical Operations Subject Matter Expert (TechOps SME) supports the Technical Operations Team through completion of SOP content review and updates, as well as performing testing personnel sign off and competency assessments, ensuring that lab processes are documented and carried out in an accurate and up-to-date manner. The TechOps SME is responsible for wet lab assay monitoring, troubleshooting, and reporting, associated quality issue investigations, operationalization of lab improvements and new techniques, and metric report development and monitoring. This position will provide support to the DNA Extraction team.

Job Responsibilities 

• Act as a liaison to the Innovation Lab and Process Improvement Lab for testing and operationalizing new or modified techniques. Assist in launching new workflows and processes in the lab through training and knowledge transfer.  
• Review and update content for SOPs, O&Ms, forms, and manuals for process changes and periodic review. 
• Complete signoffs and competencies for testing personnel, providing feedback on employee technical performance. 
• Streamline training content and develop supporting material for wet lab assay training to ensure effective and uniform knowledge transfer.
• Create and monitor a system for tracking confirmatory assay controls. Manage quality and supply concerns proactively with the TechOps and Workforce teams to minimize adverse impacts on clinical samples. 
• Contribute process improvement ideas that positively impact TAT, COGS, quality, and overall processes. 
• Participate in metric reporting and monitoring, including associated real-time investigation and troubleshooting, and present findings in relevant meetings or groups. 
• Consult with vendors and implement recommendations for issue resolution. 
• Design and perform lab experiments for assay troubleshooting and optimization.  
• Serve as DRI for assigned lab projects, meeting self-established deadlines and adjusting priorities and resources to advance projects with the greatest impact.  
• Conduct tours for Fellows and other groups needing familiarization with the wet lab.  
  
  

Education, Experience, and Skills 

• Meets CLIA, CAP, and New York State CLEP personnel standards criteria by meeting one of the following.
• PhD in medical technology, laboratory science, or in one of the chemistry, physical, or biological sciences and subsequent to gradation at least 1 year of experience in high complexity testing, or;
• Master’s degree in medical technology, laboratory science, or in one of the chemistry, physical, or biological sciences and subsequent to gradation at least 2 years of experience in high complexity testing, or;
• Bachelor’s in medical technology, laboratory science, or in one of the chemistry, physical, or biological sciences and subsequent to graduation at least 5 years of experience in high complexity testing. 
• Experience in technical operations and laboratory management.
• Strong leadership and mentoring skills.
• Excellent verbal and written communication skills.
• Proficiency in SOP development and review.
• Ability to coordinate and manage multiple projects simultaneously, meeting set deadlines. 

Work Environment 
Duties are performed on-site, with remote work available one day per month.

Schedule
Sunday-Thursday 6:30am-3:00pm