Senior Scientist, Technical Transfer

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Position Overview

The Senior Scientist, Technical Transfer role will lead variety of technical transfer activities facilitating process and product transfer into Operations. This position will work collaboratively with other departments to develop, document, and implement new processes and procedures as part of the design transfer process. This role shares accountability for ensuring the successful implementation of new or improved products and processes in Operations while relying on a team of resources outside of reporting structure.

Essential Duties

Include, but are not limited to, the following:

• Support Operations in design and development of In Vitro Diagnostic (IVD) medical device manufacturing processes and procedures in accordance with cGMP, ISO13485, and FDA guidelines.
• Leads development and characterization of complex formulation manufacturing processes and processing equipment for buffers, mixtures, and/or raw materials with unique physical or chemical attributes incorporating industry standard techniques at both small and large scale.
• Leads and develops the development build plan strategy and coordinate execution of development batches , lead Production Operators in troubleshooting issues that arise during development manufacturing.
• Leads and/or executes process development, training, and pilot scale Manufacturing for moderate and complex processes/products as well as complex buffers.
• Leads external design transfer of reagents and/or components to contract manufacturing operations.
• Support Process and Test Method Validation readiness and execution. Provides support and review in generating Validation documentation. Responsible for identifying critical processing parameters and critical quality attributes.
• Leads troubleshooting and root cause investigation efforts with understanding of recognized tools.
• Write new and edit existing Quality System documents. Recognizes CI opportunities for the Quality System and leads efforts. Responsible for generating/driving corrective actions/action plans for more complex change requests/change orders, SOPs, work instruction, receiving inspection methods, and technical summary reports. Collaborates with QE to mitigate enterprise level risk.
• Regularly coordinates activities or leads smaller sub projects within operations and with other functions. Able to generate plans, identify risk, communicate to stakeholders, and lead execution toward project milestones according to project timelines. Applies recognized project management and scheduling tools.
• Leads in identifying and developing manufacturing training strategy/techniques for new manufacturing processes.
• 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 on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 80% of a typical working day.
• Ability to work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• Ability to work seated for approximately 80% of a typical working day. Ability to work standing for approximately 80% of a typical working day.
• Ability to lift up to 30 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 10% between local Exact Sciences Madison locations.

Minimum Qualifications

• Bachelor's degree in Life Sciences, Engineering, or a related field.
• 6 years of experience in biotech manufacturing or technical transfer, within FDA regulated and/or ISO13485 environments.
• 6 years of experience utilizing Chemistry, Biochemistry, or Molecular Biology principles in a manufacturing environment.
• Proficient in Microsoft Office Suite.
• 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

• 4 years experience applying statistical techniques including control charting, data trending, hypothesis testing, variation assessment, and basic linear regression. Familiar with more advanced techniques such as DOE, MSA, Multivariate Analysis, and ANOVA.
• 2 years experience working within SAP enterprise resource planning.

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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