Sr. Associate, FDA Process Improvement

GeneDx, Inc; Gaithersburg (MD); On-site; USD 104,000 - 115,000; Full time

Job summary

GeneDx, Inc. is seeking a Process Improvement Senior Associate in Gaithersburg, MD to provide technical, scientific, and clinical expertise in optimizing workflows, ensuring quality compliance, and leading validation efforts in a molecular genetics lab.

The role emphasizes FDA-regulated development activities and broader process improvement initiatives. The candidate will support analytical validation, design controls, CAPA activities, and cross-functional communication, mentoring junior staff

Qualifications

• Bachelor'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.
• 4+ years of experience in a laboratory or process improvement setting.
• Experience in FDA-regulated lab environments with GxP principles and IVD development workflows; CLIA/CAP/NYS standards and LDT experience preferred.
• Familiarity with FDA frameworks (e.g., 21 CFR Parts 820/QMSR, 21 CFR Part 11, ISO 13485, ISO 14971) preferred.
• Strong data analysis, problem-solving, and project management skills.
• Experience with CAPA systems, deviation management, and quality event documentation.
• Lean Six Sigma or similar methodologies is preferred.

Responsibilities

• Support validation efforts for new and improved production processes, including analytical validation, verification, and FDA submission-related activities, as well as protocol development, data collection, and documentation.
• Support design control activities and maintain documentation (DHFs, technical files) per FDA regulatory requirements.
• Support investigations, root-cause analyses, CAPAs, and quality event documentation with Quality and Regulatory Affairs.
• Analyze laboratory and production workflows to identify process inefficiencies and opportunities for improvement.
• Develop and implement workflow optimizations and maintain process documentation.
• Develop and refine SOPs and training materials for process improvements.
• Provide troubleshooting support for complex process inefficiencies.
• Mentor junior associates on process improvement methodologies and best practices.
• Ensure all process changes meet regulatory requirements and quality standards.
• Work with cross-functional teams to communicate and implement findings.
• Support and train production personnel in process improvement and new workflows.

Skills

Data analysis

Problem solving

Project management

Regulatory compliance

Lean Six Sigma

Education

Bachelor's degree (Molecular Biology/Genetics/Biotech)

PhD in Biology/Genetics or related

ABMGG diplomate or ABGC certification

Tools

GxP Knowledge

IVD development workflows

Job description

Follow your passion. Advance your career . Make a lasting impact.

It all starts here.

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 Process Improvement Senior Associate is responsible for providing technical, scientific, and/or clinical expertise in process improvement projects, focusing on optimizing workflows, ensuring quality compliance, and leading validation efforts in the molecular genetics lab. This role has a primary focus on supporting FDA and regulated lab development activities, while also contributing to broader process improvement initiatives as business needs evolve.

Job Responsibilities

• Support validation efforts for new and improved production processes, including analytical validation, verification, and FDA submission-related activities (e.g., Pre-Submission meetings, IVD development), as well as protocol development, data collection, and documentation.
• Support design control activities and maintain associated documentation (DHFs, technical files) in accordance with applicable FDA regulatory requirements.
• Support investigations, root-cause analyses, CAPAs, and quality event documentation in partnership with Quality and Regulatory Affairs.
• Analyze laboratory and production workflows to identify process inefficiencies and opportunities for improvement.
• Develop and implement workflow optimizations and maintain process documentation.
• Develop and refine SOPs and training materials for process improvements.
• Provide troubleshooting support for complex process inefficiencies.
• Mentor junior associates on process improvement methodologies and best practices.
• Ensure all process changes meet regulatory requirements and quality standards.
• Work with cross-functional teams to communicate and implement findings.
• Support and train production personnel in process improvement and/or new process workflows.
• Performs other duties assigned in support of the team or department.

Education, Experience, and Skills

• Bachelor’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
• 4+ years of experience in a laboratory or process improvement setting
• Experience working in an FDA-regulated laboratory environment, including familiarity with GxP principles (GMP, GLP, or GCP as applicable) and IVD development workflows; CLIA/CAP/NYS laboratory standards and LDT experience preferred
• Familiarity with relevant FDA regulatory frameworks, including 21 CFR Parts 820/QMSR, 21 CFR Part 11, ISO 13485, and/or ISO 14971, is preferred
• Strong data analysis, problem-solving, and project management skills
• Experience with regulatory compliance, documentation, and validation principles
• Experience with CAPA systems, deviation management, and quality event documentation
• Familiarity with Lean Six Sigma or similar methodologies is preferred

Certificates, Licenses, Registrations

• 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.

This position is based in our laboratory facility in Gaithersburg, Maryland. Work is performed in a laboratory setting that may involve exposure to biological materials, chemicals, and specialized equipment. The environment requires adherence to safety protocols, use of personal protective equipment (PPE), and compliance with regulatory standards. Noise levels vary from moderate to loud depending on equipment operation. Your standard work schedule and hours will be established in collaboration with your leader and may be adjusted to align with evolving business needs.

Physical Demands

• Combination of standing, walking, and sitting throughout the workday.
• Fine motor skills and manual dexterity for handling samples, pipettes, and laboratory instruments.
• Visual acuity for analyzing samples, reading measurements, and operating precision equipment.
• Occasionally lifting and carrying up to 25-50 pounds (equipment, sample containers, supply boxes).
• Reaching, bending, and stooping to access equipment and storage areas.
• Repetitive hand and wrist movements for sample preparation and testing.
• Ability to wear required PPE including lab coats, gloves, safety glasses, and masks.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

Pay Transparency, Budgeted Range

$104,000 - $115,000 USD

A culture that plays to win, because patients are counting on us

At GeneDx, we're driven by urgency and purpose: helping patients get diagnosed earlier. Our mission, to empower everyone to live their healthiest life through genomics, drives our team to make a tangible impact each day – and shapes our culture where high standards, strong teamwork, and meaningful ownership are the norm. We act with intention, support one another, and deliver work we're proud to put our names on.

Here’s what you can expect day to day:

1. Play like a champion (step up, redefine what’s possible, own it)

We bring energy, focus, and a bias for action. We step up, take initiative, and deliver on our commitments – with quality, speed, and care.

2.Think bigger (stretch beyond, courage not consensus)

We push past the obvious. We challenge assumptions, raise the bar, and make thoughtful, decisive calls — choosing progress over perfection.

3.Grow fast (be curious, speak up, be agile)

We stay curious, ask questions, and share direct feedback with respect. We adapt quickly and keep learning through collaboration and continuous improvement.

If you’re motivated by meaningful work, a fast-moving environment, and teammates who care deeply about outcomes, you’ll thrive at GeneDx.

At GeneDx, we believe in taking care of our people. We provide competitive compensation and benefits that reflect local market practices and legal requirements in each country where we operate, helping employees thrive both professionally and personally.

We welcome everyone regardless of their background. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, disability, age, and other characteristics protected by law.

GeneDx is a place where people from all backgrounds can make an impact.

All privacy policy information can be found here .

GeneDx Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in GeneDx’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp .

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability.Disabilities include, but are not limited to:

• Alcohol or other substance use disorder (not currently using drugs illegally)
• Blind or low vision
• Cancer (past or present)
• Cardiovascular or heart disease
• Celiac disease
• Cerebral palsy
• Deaf or serious difficulty hearing
• Diabetes
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• Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
• Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
• Missing limbs or partially missing limbs
• Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
• Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
• Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
• Partial or complete paralysis (any cause)
• Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema

Thank you for helping us create a more inclusive and equitable hiring process.

GeneDx uses AI to aid in our hiring process, where Greenhouse’s Talent Match (“GTM”) feature is used to review applications. Our hiring team actively directs GTM to establish and weigh the relevant job requirements. Resumes and applicant input are accordingly reviewed by GTM to determine if the applicant qualifies for further non-AI evaluation. All output from GTM requires human oversight before we arrive at any final decision. GTM does not automatically make any hiring decisions.