Product Support Scientist

Exact Sciences • Madison, WI

1d • $74,000 - $122,000 • Onsite

About The Position

At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer. We give patients and clinicians the clarity needed to make confident decisions when they matter most. Join our team to find a purpose-driven career, an inclusive culture, and robust benefits to support your life while you’re working to help others. Position Overview The Product Support Scientist plays a key role in providing technical expertise to the Value Stream Product Support team within Operations. This position leverages scientific methodologies to troubleshoot and resolve product related issues, including Out-of-Specifications (OOS), Non-Conforming Material Reports (NCMRs), and failure investigations. By driving root cause analysis, corrective actions, and continuous improvement initiatives, the Product Support Scientist helps ensure product quality and operational excellence. This role is located in Madison, WI and is onsite 5 days/week.

Requirements

• 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.

Nice To Haves

• 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.

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.
• Deliver on commitments and support timeline adherence.
• Collaborate effectively across teams and functions.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Ability to lift up to 50 pounds occasionally.
• Comfortable working at a lab bench or on a computer for most of the day.
• Ability and means to travel between Madison locations.
• Travel up to 5% (may include occasional overnight/weekend travel).
• Ability to utilize lab equipment for approximately 75% of a typical working day.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 60% of a typical working day.
• Ability to grasp with both hands; pinch with thumb and forefinger; turn with hand/arm; reach above shoulder height.
• Ability to work on a computer and phone simultaneously.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability to work with blood, tissue, stool, or other human specimen samples.

Benefits

• paid time off (including days for vacation, holidays, volunteering, and personal time)
• paid leave for parents and caregivers
• a retirement savings plan
• wellness support
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees