Staff Scientist, Assay Transfer and Method Development

Responsibilities

• Lead and coordinate assay transfer and method development activities within Operations
• Oversee the transfer and implementation of analytical and functional tests for product characterization and release
• Collaborate cross-functionally with production, quality control, R&D, and quality engineering teams
• Lead test method development, characterization studies, and Measurement System Analysis (MSA)
• Program and operate complex instrumentation including PCR, HPLC, and liquid handling automation
• Use data analytics and statistical tools to monitor trends and lead troubleshooting or root cause investigations
• Generate experimental protocols, work instructions, and technical summary reports
• Support Process Validation and lead Test Method Validation readiness and execution
• Manage project timelines and communicate progress to Operations Leadership

Requirements

• Bachelor's degree in life sciences or a related field
• 8+ years of experience in the life sciences industry
• Strong knowledge of Chemistry, Biochemistry, or Molecular Biology
• Expert understanding of IVD manufacturing processes and relevant assays (e.g., RT-PCR, NGS)
• 4 years of experience working in an FDA 21 CFR 820, ISO 13485, or cGMP environment
• Proficiency in MS Office Suite

Preferred Qualifications

• Advanced degree (MS or PhD) in Biology, Chemistry, or a similar discipline
• Proficiency with statistical analysis software such as JMP or R
• Experience developing automated liquid handling workflows on Hamilton robotic platforms
• Experience with in vitro diagnostic product development, design transfer, or manufacturing support
• Familiarity with Project Management Principles and SAP (ERP)
• Knowledge of CAP/CLIA regulatory requirements

Benefits

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

About the Company

Exact Sciences is helping change how the world prevents, detects, and guides treatment for cancer. We provide patients and clinicians with the clarity needed to make confident decisions when they matter most.