Manager, Process Development and Automation

Responsibilities

• Lead the Process Development and Automation team in systems design, validation, and implementation within a regulated laboratory environment
• Provide leadership, coaching, and mentorship to engineers and scientists to foster a high-performance culture
• Oversee day-to-day functionality, task delegation, and performance assessments for the team
• Drive continuous improvement projects and implement changes to ensure high-quality laboratory processes
• Collaborate with cross-functional teams to determine root causes for production failures and resolve technical issues
• Ensure compliance with all applicable regulatory requirements, including CLIA, CAP, and ISO 13485
• Manage the issue escalation process for instrumentation and support requests from business units

Requirements

• Bachelor's Degree in Engineering, Biology, Molecular Biology, or a related scientific field
• 8+ years of experience in process development, laboratory automation, or service engineering
• 2+ years of experience in laboratory management, technical leadership, or a role with increasing responsibility
• Proficiency in SolidWorks, JMP, or similar computer-aided design and statistical analysis software
• Experience designing and implementing integrated automated and manual workflows in a regulated environment
• Working knowledge of regulatory standards such as CLIA, CAP, or ISO 13485
• Ability to travel up to 40% of the time

Preferred Qualifications

• Prior experience in the Medical Device, Diagnostic, or Life Science industries
• Experience supporting a Clinical Laboratory conducting high-complexity diagnostic tests
• Hands-on experience with Lean Six Sigma methodologies (e.g., Root Cause Analysis, 5S, VSM)
• 4+ years of experience in test method validation and development
• Experience with LIS configuration and User Acceptance Testing (UAT) verification

Benefits

• Paid time off including vacation, holidays, and personal time
• Paid leave for parents and caregivers
• Retirement savings plan
• Comprehensive health benefits including medical, prescription drug, dental, and vision coverage
• Wellness support programs

About the Company

Exact Sciences is dedicated to changing how the world prevents, detects, and guides treatment for cancer. We provide patients and clinicians with the clarity needed to make confident decisions through innovative diagnostic testing and personalized healthcare solutions.