Senior Production Scientist

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Position Overview

The Senior Production Scientist position will identify, coordinate, and lead projects or initiatives to drive performance, deepen the overall operator training and development experience, and improve efficiency within the Production department, working closely with Production leadership and other functional leaders. This position will lead, train, and assist the production team in continuous improvement activities related to production processes and transfer of new products into production from the technical transfer team. This role will lead through influence of indirect team members. This position is expected to possess an extensive understanding of laboratory procedures and a strong technical understanding of the science behind them working within cGMP guidelines.

Essential Duties

Include but are not limited to the following:

• Lead in the continuous development, refinement and oversight of the operator certification program.
• Manage or lead simple to complex process improvement and new product implementation projects.
• Perform classroom, on-the-job training and instructor qualification of Production staff.
• Effectively communicate with multi-level personnel as well as outside vendors and their representatives.
• Assist in maintaining the production schedule.
• Work on several varied projects at one time, with frequently changing priorities.
• Work effectively in team situations as well as independently.
• Prioritize tasks and adhere to project schedules and timelines.
• Ability to thrive in a fast-paced, frequently changing, and evolving environment.
• Review, update and develop SOPs, workflows, and training programs related to Production processes.
• Keep all documentation policies and procedures up to date to meet the Quality Manual System (QMS) and regulatory requirements.
• Provide in and out of lab leadership, as a technical expert, for all personnel within the Production team to ensure the successful, effective, efficient, and safe preparation of quality finished goods.
• Act as Subject Matter Expert (SME) on core functions of the Production organization (e.g., reagent manufacturing, product finishing, new product implementation, and process improvement).
• Lead complex investigations, deviations, non-conformances, and CAPAs as they relate to production activities.
• Develop performance metrics and productivity metrics to drive process improvements and ensure visibility to leadership and team.
• Lead continuous improvement efforts or Kaizen projects to maintain or improve laboratory support processes and lab spaces, such as 5S and Lean Manufacturing efforts.
• Represent Production in routine cross-functional team settings (e.g., Material Review Board) or on project-based teams.
• Lead or assist in developing, transferring, scaling, and validating manufacturing processes, including formulation, filling, labeling, and packaging, in accordance with company procedures, cGMPs, FDA, and ISO 13485 guidelines.
• Extensive analytical and problem-solving skills; ability to make decisions with limited information and operate with autonomy.
• Strong communication skills; ability to influence and coordinate work with Production and other functional area leadership.
• Strong business acumen and strategic agility driving innovative solutions and new ideas forward.
• Ability to influence others, deliver on team vision, and hold partners accountable to timelines.
• Ability to accurately follow procedures with minimal direction.
• Ability to communicate clearly to other departments, as necessary, to drive alignment and visibility.
• Extensive documentation, attention-to-detail, and procedure writing skills suitable for a cGMP environment.
• Excellent oral and written communication and strong interpersonal skills.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Regular and reliable attendance.
• Ability to lift up to 40 pounds for approximately 10% of a typical working day.
• Ability to work seated for approximately 50% of a typical working day. Ability to work standing for approximately 50% 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 50% 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 overhead mixers, scales, automated filling equipment, 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 between Madison locations.
• Ability to travel 5% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Bachelor's degree in Life Sciences; or related field or the equivalent combination of education and experience.
• 8+ years of experience in a manufacturing or life sciences environment.
• 3+ years of experience in an FDA regulated 21 CFR 820 and/or ISO 13485 environment or equivalent.
• 1+ years of experience leading projects or business initiatives and driving results.
• Experience as a subject matter expert on cGMP/IVD product manufacturing processes.
• Experience communicating and documenting complex subjects for distribution to a wide audience.
• Proficient in Microsoft Office Suite, internet navigation, and email usage.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.
• Authorization to work in the United States without sponsorship.

Preferred Qualifications

• 5+ years of leadership experience in a manufacturing environment.
• 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.
• Experience in a biotech manufacturing environment.
• Experience with ERP systems, such as SAP.

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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