Principal Scientist, Quality Control

Exact Sciences • Madison, WI

2d

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 Principal Scientist, Quality Control provides strategic scientific leadership, serving as the primary technical authority for QC analytical method lifecycle management, stability strategy, and complex problem‑solving across the product portfolio. This role is accountable for driving QC technical direction, establishing long‑term analytical strategies, and ensuring enterprise‑level alignment with regulatory and business objectives.

Requirements

• Bachelor’s Degree in a field related to essential duties; or Associates Degree and 2 years of relevant experience; or High School Diploma or General Education Degree (GED) and 4 years of relevant experience.
• 12 years of experience in industry with biochemical and molecular based products.
• Demonstrated proficiency 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 21CRF Part 820, ISO 13485, and /or cGMP structured environments.
• Proficiency in Microsoft Office programs, such as Word, Excel, PowerPoint, Outlook, Access, and OneNote.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.
• Applicants must be currently authorized to work in country where work will be performed on a full or part-time basis. We are unable to sponsor or take over sponsorship of employment visas at this time.

Nice To Haves

• Advanced degree (Ph.D., M.S., etc.) in biology, chemistry, or a related field.
• 10+ years of experience with Medical Device Products in a Quality Control, Product Development, or Product Support role.
• Experience with Project Management principles and practice.

Responsibilities

• Define the long‑term stability strategy for clinical and commercial products, including study design, supporting statistical justification, and regulatory alignment.
• Provide technical leadership and strategic direction for the full analytical method lifecycle, including design, risk assessment, validation strategy, and long‑term method sustainability.
• Serve as the primary technical leader for highly complex or cross‑functional investigations, providing expert interpretation and advising leadership on corrective strategies.
• Author or review comprehensive technical reports and investigation summaries.
• Lead method improvements and work cross functionally with teams to design and implement changes via measurement systems analyses (MSAs), test method validations (TMVs), and implementation.
• Provide mentorship at the scientific and strategic level, guiding experimental design decisions, data interpretation approaches, and long‑term technical development for the QC organization.
• 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.
• Maintain regular and reliable attendance.
• Ability to act with an inclusion mindset and model these behaviors for the organization.
• Ability to work designated schedule.
• Ability to work nights and/or weekends, as needed.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day.
• Ability to work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• Ability to lift up to 40 pounds for approximately 5% 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 comply with any applicable personal protective equipment requirements.
• Ability to use various types of laboratory equipment; including microscopes, microtomes, blades, strainers, and pipettes for extended periods of time.
• May perform repetitious actions using lab tools.
• Ability to use near vision to view samples at close range.
• May be exposed to hazardous materials, tissue specimens, and instruments with moving parts, lasers, heating and freezing elements, and high-speed centrifugation.
• Ability and means to travel 5% between local Exact Sciences Madison locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

Benefits

• Exact Sciences is proud to offer an employee experience that includes paid time off (including days for vacation, holidays, volunteering, and personal time), paid leave for parents and caregivers, a retirement savings plan, wellness support, and health benefits including medical, prescription drug, dental, and vision coverage.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal