GeneDx
Lead, Laboratory Process Improvement(Hybrid)
GeneDx - Gaithersburg, Maryland, United States, 20877
Work at GeneDx
Overview
- View job
Overview
Lead, Laboratory Process Improvement
GeneDx 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. Summary 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. Job Responsibilities Lead and execute strategic process improvement initiatives across functions Analyze complex production workflows and identify opportunities for optimization Coordinate cross-functional teams to develop and validate new workflows Provide advanced troubleshooting and problem-solving for technical issues Lead and execute protocol development, execution, validation, and documentation Ensure compliance with regulatory standards Mentor and train junior associates within the department Support and train personnel in process improvement and/or new process workflows Performs other duties assigned in support of the team or department If applicable, may fulfill the responsibilities of Clinical Consultant as defined by CLIA, with respect to one or more type of testing at GeneDx. People Manager 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. Education, Experience, and Skills 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. 6+ years of experience in a laboratory or process improvement setting Strong experience in process validation, regulatory compliance, and quality systems Experience with New York State-licensed laboratory preferred Proven ability to lead cross-functional teams and drive efficiency improvements Familiarity with Lean Six Sigma or similar methodologies is preferred Certificates, Licenses, Registrations If applicable: 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 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 Physical Demands 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. Work Environment 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. #LI-REMOTE Pay Transparency, Budgeted Range $114,789 - $153,052 USD 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. 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. 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. 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 jobyou'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.
GeneDx 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. Summary 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. Job Responsibilities Lead and execute strategic process improvement initiatives across functions Analyze complex production workflows and identify opportunities for optimization Coordinate cross-functional teams to develop and validate new workflows Provide advanced troubleshooting and problem-solving for technical issues Lead and execute protocol development, execution, validation, and documentation Ensure compliance with regulatory standards Mentor and train junior associates within the department Support and train personnel in process improvement and/or new process workflows Performs other duties assigned in support of the team or department If applicable, may fulfill the responsibilities of Clinical Consultant as defined by CLIA, with respect to one or more type of testing at GeneDx. People Manager 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. Education, Experience, and Skills 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. 6+ years of experience in a laboratory or process improvement setting Strong experience in process validation, regulatory compliance, and quality systems Experience with New York State-licensed laboratory preferred Proven ability to lead cross-functional teams and drive efficiency improvements Familiarity with Lean Six Sigma or similar methodologies is preferred Certificates, Licenses, Registrations If applicable: 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 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 Physical Demands 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. Work Environment 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. #LI-REMOTE Pay Transparency, Budgeted Range $114,789 - $153,052 USD 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. 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. 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. 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 jobyou'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.