Technical Operations Subject Matter Expert

Posted 20 Days Ago
Be an Early Applicant
Gaithersburg, MD
In-Office
87K-110K Annually
Senior level
Healthtech • Biotech
The Role
The TechOps SME supports lab processes through SOP content review, training, troubleshooting, and quality issue investigations, enhancing operational efficiency.
Summary Generated by Built In

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


Pay Transparency, Budgeted Range
$87,441$110,000 USD

~

Science - Minded, Patient - Focused. 

At GeneDx, we create, follow, and are informed by cutting-edge science. With over 20 years of expertise in diagnosing rare disorders and diseases, and pioneering work in the identification of new disease-causing genes, our commitment to genetic disease detection, discovery, and diagnosis is based on sound science and is focused on enhancing patient care.

Experts in what matters most. 

With hundreds of genetic counselors, MD/PhD scientists, and clinical and molecular genomics specialists on staff, we are the industry’s genetic testing experts and proud of it. We share the same goal as healthcare providers, patients, and families: to provide clear, accurate, and meaningful answers we all can trust.

SEQUENCING HAS THE POWER TO SOLVE DIAGNOSTIC CHALLENGES.

From sequencing to reporting and beyond, our technical and clinical experts are providing guidance every step of the way:

TECHNICAL EXPERTISE

  • High-quality testing: Our laboratory is CLIA certified and CAP accredited and most of our tests are also New York State approved.
  • Advanced detection: By interrogating genes for complex variants, we can identify the underlying causes of conditions that may otherwise be missed.

CLINICAL EXPERTISE

  • Thorough analysis: We classify variants according to our custom adaptation of the most recent guidelines. We then leverage our rich internal database for additional interpretation evidence.
  • Customized care: Our experts review all test results and write reports in a clear, concise, and personalized way. We also include information for research studies in specific clinical situations.
  • Impactful discovery: Our researchers continue working to find answers even after testing is complete. Through both internal research efforts and global collaborations, we have identified and published hundreds of new disease-gene relationships and developed novel tools for genomic data analysis. These efforts ultimately deliver more diagnostic findings to individuals.

Learn more About Us here.

Our Culture

At GeneDx, we are dedicated to cultivating an environment where creativity and innovation thrive. We believe in the power of community and collaboration, where diverse perspectives are embraced, and every voice contributes to our shared success. Our team is a vibrant mix of professionals who challenge and support each other in equal measure, fostering growth both personally and professionally. When you join us, you're not just taking on a job—you're joining a movement. A movement that champions curiosity, embraces change, and believes in making an impact, one patient at a time. Cultural principles we live by:  

  • Be bold in our vision & brave in our execution. 
  • Communicate directly, with empathy. 
  • Do what we say we're going to do.  
  • Be adaptable to change.  
  • Operate with a bias for action.    

Benefits include:

  • Paid Time Off (PTO)
  • Health, Dental, Vision and Life insurance
  • 401k Retirement Savings Plan
  • Employee Discounts
  • Voluntary benefits

GeneDx is an Equal Opportunity Employer.
All privacy policy information can be found here.

Top Skills

Data Analysis
Genomic Testing
Lab Management
Sop Development
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The Company
HQ: Stamford, Connecticut
802 Employees

What We Do

GeneDx is focused on delivering personalized, actionable insights that improve health outcomes. We sit at the intersection of diagnostics and data science, pairing decades of genomic expertise with an unmatched ability to interpret clinical data at scale.

Our exome and genome testing is among the best in the industry. We expect that it will be even more advanced in the future with the help of Centrellis®, our innovative health information platform. Powered by millions of medical records, Centrellis® integrates digital tools with artificial intelligence to ingest and synthesize clinical and genomic data.

As a result of our robust test menu, including our exome and genome testing, and the comprehensive insights generated by Centrellis®, we are developing a more complete understanding of complex disease than ever before. This translates to faster diagnosis, more effective treatment plans, and enhanced drug discovery.

Our offerings help a whole spectrum of healthcare partners -- clinicians, researchers, health systems, pharmaceutical companies, and payors -- improve patient experiences and advance population health

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