Manager, Process Development

Responsibilities

• Oversee tech transfers, process improvements, and best practice development for the Extractions Lab
• Manage a direct team responsible for change control, document updates, and stakeholder interaction
• Design the form and content of documents pertaining to Extractions procedures
• Identify opportunities for process and workflow improvements and direct implementation projects
• Represent Extraction team needs during product launches
• Coordinate with engineering, quality, and regulatory stakeholders to secure resources
• Mentor and develop subordinates through coaching, reviews, and training

Requirements

• Ph.D. in Molecular Biology or a related field, or equivalent
• At least 6 years of industry experience in genetic testing or a related field
• Previous management experience
• Experience working in a regulated environment (GMP, ISO, CLIA, CAP, FDA)
• Strong technical expertise in molecular biology and NGS-based laboratory assays
• Proven track record of successful project management and process improvement

Preferred Qualifications

• Previous experience with assay development and/or QC
• CLIA/FDA laboratory support experience
• Experience with formal quality management systems
• Experience with development and documentation of standard operating procedures

About the Company

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The company aims to make personalized genetic testing and diagnostics part of the standard of care to enable earlier and more targeted interventions.