Sr. Associate, FDA Process Improvement

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.

Work Environment 

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 

This role requires physical activity including: 

• 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.