Lead Scientist Design Transfer

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At Exact Sciences were helpingchange 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 youre working to help others.

Position Overview

The Lead Scientist Design Transfer role will lead and oversee a variety of design transfer activities within Research and Development. This position will work alongside the Product Development Teams and Operations to lead and facilitate Design Transfer activities. The Lead Scientist Design Transfer works independently or in collaboration with others on one or more projects which are complex in scope. This position involves independently making detailed observations investigating issues planning experiments analyzing data interpreting results providing insights and directing next steps as the product transitions through the Design Transfer process.

Essential Duties

Include but are not limited to the following:

• Provide technical and product support leadership in Research and Development working cross-functionally with the Manufacturing Sciences and Quality Control Product Support Technical Services Supply Chain Regulatory and Quality teams.
• Work with development teams to assess and resolve any issues related to raw materials and/or develop new processes to improve reliability of incoming materials.
• Organize present and convey complex problems and information at project meetings and across other functions.
• Prepare reports and analysis of results as related to product/process development and improvement.
• Present clear project summaries in written and verbal formats to internal and external scientific and management teams.
• Participate in technical decisions identify problems investigate alternatives and recommend possible courses of action.
• Lead or provide oversight of the Development Team completing reagent design transfer test method transfer and validation activities for new or existing products.
• Provide post-transfer support (e.g. process capability analysis QC reagent and sample qualification QC results troubleshooting etc.)
• Characterize assay and formulation variability using Measurement System Analysis (MSA) and Design of Experiment (DOE) for complex systems.
• Lead investigations into analytical and functional test methods and associated equipment during the transfer process of methods into operations.
• Interpret challenges and recommend best practices for design transfer to advance processes and methodologies and/or improve efficiency and quality for product development.
• Collaborate cross-functionally with Manufacturing Sciences and Quality Control Product Support Technical Services Supply Chain Regulatory and Quality to support and improve processes and procedures that drive quality and efficiency.
• Lead design transfer activities across assigned projects.
• Act as subject matter expert in core team and/or cross-functional meetings.
• Mentor junior members of team.
• Utilize excellent verbal and written communication skills to convey important messages and drive focus through a variety of communication methods.
• Uphold company mission and values through accountability innovation integrity quality and teamwork.
• Support and comply with the companys 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 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 lift up to 20 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 between local Exact Sciences Madison locations.
• Ability to travel 5% of working time away from work location may include overnight/weekend travel.

Minimum Qualifications

• Bachelors Degree in life sciences or field related to the essential duties of the job.
• 10 years of experience in the life sciences industry. Masters or Doctoral degrees may be considered in lieu of 2 years of experience.
• 5 years of experience in medical device/IVD biotech life science or pharmaceutical industry.
• 5 years working within an FDA 21 CFR 820 ISO 13485 ISO12207 and/or cGMP structured environment.
• Excellent knowledge of product/assay design and development.
• Demonstrated ability to apply molecular biology and/or biochemical techniques.
• Proficient in MS Office Suite (Word Excel Outlook PowerPoint).
• 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

• 12 years of industry or academic research experience in Life Sciences Chemistry or related field.
• 7 years of experience in medical device/IVD biotech life science or pharmaceutical industry.
• Previous experience working in a molecular diagnostics/clinical laboratory setting.
• Proficiency with statistical analysis software and/or programing (e.g. JMP R).
• Experience with automated liquid handling workflows on robotic platforms.
• Experience using Electronic Quality Management System (EQMS) software (Agile preferred).
• Familiarity with CAP/CLIA regulatory requirements as they pertain to in vitro diagnostics.

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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