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Exact Sciences · 3 days ago

Product Support Scientist

US - WI - Madison

Full-time

Onsite

Entry, Mid Level

$74K/yr - $122K/yr

2+ years exp

Exact Sciences is dedicated to changing how the world prevents, detects, and guides treatment for cancer. The Product Support Scientist will provide technical expertise to the Value Stream Product Support team, leveraging scientific methodologies to troubleshoot and resolve product-related issues while ensuring product quality and operational excellence.

BiotechnologyHealth DiagnosticsManufacturingMedical

No H1B

Responsibilities

Partner cross-functionally to support and lead troubleshooting of OOSs, NCMRs, and CAPAs through root cause analysis, experimental design, data analysis, and reporting

Support and lead investigations of complex assays, equipment, materials and processes

Analyze and trend historical data using statistical process control techniques to inform decision-making and process optimization

Support material evaluations and sourcing decisions

Program, operate, and troubleshoot complex instrumentation (e.g., micro plate readers, real-time PCR instruments, liquid handling automation, and next-generation sequencers)

Author and review protocols, procedures, test methods, and technical reports

Support characterization of assay and formulation variability using MSA and DOE principles

Assist in the training and transfer of processes and/or procedures as part of corrective action implementation

Communicate complex findings clearly to both technical and non-technical audiences

Qualification

Molecular biology techniquesStatistical analysisIVD product manufacturingExperimental designData analysisContinuous improvementQuality managementTeam collaborationTechnical communicationProblem solving

Required

Master's degree in life sciences, or related field; or Bachelor's degree in life sciences, or related field, and 2 years of relevant experience as outlined in the essential duties in lieu of Master's degree

2+ years of experience in the biotech industry

2+ years of hands-on experience in molecular biology and biochemical techniques

Advanced knowledge of statistical and mathematical methods in biology/genetics, including experience with JMP software

Demonstrated understanding of IVD product manufacturing processes and biochemical, molecular, and real-time PCR Assays

Demonstrated ability to apply common laboratory skills and techniques; including a base knowledge in chemistry, biochemistry, molecular biology, or a related field

Authorization to work in the United States without sponsorship

Demonstrated ability to perform the Essential Duties of the position with or without accommodation

Preferred

Minimum of 5 years of experience in IVD product development, design transfer, manufacturing, or product support

Proven ability to lead technical investigations involving complex assays and manufacturing processes

Strong proficiency in experimental design and data analysis generating evidence-based conclusions

Hands-on experience with statistical analysis tools and techniques, particularly using software such as JMP

Familiarity with continuous improvement methodologies, project management practices, and electronic quality management systems (EQMS), with preference for Agile and/or Oracle Cloud platforms

Applied knowledge of regulatory frameworks including 21 CFR Part 820, ISO 13485, and cGMP standards

Experience implementing formal continuous improvement systems such as A3-problem solving, value stream analysis, and kaizen blitz initiatives