Exact Sciences is looking to solve the problem of changing how the world prevents, detects, and guides treatment for cancer by providing clarity to patients and clinicians for confident decision-making.
Requirements
- Advanced knowledge in statistical and mathematical methods in biology/genetics, including experience with JMP software.
- Proficient in knowledge of IVD product Manufacturing processes, Product Design, and Development.
- Professional working knowledge with 21 CFR Part 820, ISO 13485, and/or cGMP structured environments.
- Strong knowledge in Design for Six Sigma.
- Strong knowledge in basic and advanced continuous improvement methodologies/ principles such as LEAN Six Sigma and/or Practical Process Improvements (PPI).
- Experience with Project Management principles and practice.
- Ability to utilize lab equipment for 25% of a typical working day.
Responsibilities
- Lead troubleshooting of Out Of Specifications (OOS), non-conformances (NCMRs), product and process failure mode and effects analyses (FMEAs), and corrective action preventive action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis, and reporting.
- Exercise subject matter expertise across diverse technical disciplines to guide key decisions within operations and on cross-functional teams.
- Clearly and accurately generate experimental protocols, draft work instruction procedures, characterize and develop test methods and test method improvements, summarizing activities through technical or investigative reports.
- Lead Operations teams for qualifying new raw materials and alternative supply channels for products.
- Analyze, track, and trend historical Production and Quality Control data.
- Program, operate, and troubleshoot complex instrumentation such as micro plate readers, Real-Time PCR instruments, and liquid handling automation.
- Oversee design and execution of complex studies, measurement systems analyses (MSAs) and designed experiments.
Other
- Provide technical and product support leadership in Operations working cross-functionally with the Manufacturing Sciences, Production, QC, Supply Chain, R&D, and Quality teams.
- Provide thought leadership and mentorship.
- Support and comply with the company’s Quality Management System policies and procedures.
- Communicate to all levels within the company and thrives in a fast-paced, everchanging environment.
- Ability to work designated schedule.
