Tech Transfer Scientist, Biotech Manufacturing

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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 Core Scientist, Technical Transfer role will lead and assist a variety of technical transfer activities facilitating process and product transfer into Operations. This position will develop, document, and implement new processes and procedures as part of the design transfer process.

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, ISO
  13485, and FDA guidelines.
• Assists execution of development batches per a defined build plan, assists Production Operators in troubleshooting issues that arise during development manufacturing.
• Develops and characterizes moderately complex manufacturing processes incorporating industry standard techniques.
• Executes process development pilot scale manufacturing for moderately complex processes/products as well as more complex buffers.
• Supports 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. Supports identifying critical processing parameters and critical quality attributes.
• Assists and may lead troubleshooting and root cause investigation efforts with understanding of recognized tools.
• Write new and edit existing Quality System documents. Recognizes continuous improvement opportunities for the Quality System. 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.
• Participates 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.
• 4 years of experience in biotech manufacturing or technical transfer, within FDA regulated and/or ISO
  13485 environments.
• 4 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…