Principal Scientist, Quality Control

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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 problemsolving across the product portfolio. This role is accountable for driving QC technical direction, establishing longterm analytical strategies, and ensuring enterpriselevel alignment with regulatory and business objectives.

Essential Duties

Include, but are not limited to, the following:

• Define the longterm 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 longterm method sustainability.
• Serve as the primary technical leader for highly complex or crossfunctional 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 longterm 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.

Minimum Qualifications

• 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.

Preferred Qualifications

• 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.

Salary Range:

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. Learn more about our benefits.

Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging. If you require an accommodation, please contact us here.

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We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to disability, protected veteran status, and any other status protected by applicable local, state, or federal law.

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