Senior Production Scientist

Help us change lives

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 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,…