Staff Scientist, Assay Transfer And Method Development

Exact Sciences

San Diego, CA, US
Base: $130,000-$185,000; bonus: eligible; benefits...
Assay transfer and method development leadership
Fda 21 cfr 820 and cgmp compliance experience
Statistical analysis including doe and msa
This role leads the transfer and implementation of analytical and functional tests to characterize and release cancer diagnostic products within operations

Job Summary

  • This role leads the transfer and implementation of analytical and functional tests to characterize and release cancer diagnostic products within operations.
  • The position requires expert-level statistical skills including Design of Experiments (DOE), Measurement System Analysis (MSA), and control charting to ensure data integrity.
  • Exact Sciences offers robust benefits including paid time off, parental leave, wellness support, and comprehensive health coverage for this purpose-driven career.

Matching Summary

This role leads the transfer and implementation of analytical and functional tests to characterize and release cancer diagnostic products within operations.

Salary

Base: $130,000-$185,000; Bonus: Eligible; Benefits: PTO, parental leave, retirement plan, medical/dental/vision

Skills & Requirements

Must-have

  • Assay transfer and method development leadership
  • FDA 21 CFR 820 and cGMP compliance experience
  • Statistical analysis including DOE and MSA
  • Instrumentation operation (PCR, HPLC, liquid handling)
  • Test method validation and troubleshooting

Nice-to-have

  • Experience with Hamilton robotic platforms
  • Proficiency in JMP or R programming
  • SAP Enterprise Resource Planning knowledge
  • CAP/CLIA regulatory familiarity
  • Project management principles application

Key Requirements

  • Bachelor's degree in life sciences required
  • 8+ years of life sciences industry experience
  • 4+ years in FDA 21 CFR 820/cGMP environments
  • Authorization to work in the United States without sponsorship

Work Rights

Must have US work authorization

Tailored Resume

Cover Letter