Lead Scientist Design Transfer

Lead Scientist Design Transfer Exact Sciences Corporation

• 3.2 Madison, WI Job Details Full-time $112,000
• $190,000 a year 1 day ago Benefits Paid parental leave Health insurance Dental insurance Paid time off Vision insurance Retirement plan Qualifications Research design Microsoft Outlook Doctoral degree Robotic systems Phone communication Regulatory compliance R Process improvement Quality management GMP Assay development Molecular biology techniques Master's degree Team development Microscope proficiency Product development projects Bachelor's degree Team management Decision making Medical laboratory work Laboratory quality control Mentoring CLIA regulations Experimental design Pipetting Agile Typing JMP Quality systems Senior level Research and development project management Cross-functional collaboration Research findings presentation Project leadership Research & development 2 years Communication skills

ISO 13485

Molecular biology Cross-functional communication Supply chain collaboration FDA regulations Statistical analysis tools Mobile devices Full Job Description 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 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 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 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 Bachelor's Degree in life sciences or field related to the essential duties of the job. 10+ years of experience in the life sciences industry. Master's 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. #LI-AN1

Salary Range:

$112,000.00

• $190,000.00 The annual base salary shown is for this position located in US
• WI•Madison on a full-time basis.

In addition, this position is bonus eligible. 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. Not ready to apply? Join our Talent Community to stay updated on the latest news and opportunities at Exact Sciences. 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. To view the Right to Work, E-Verify Employer, and Pay Transparency notices and Federal, Federal Contractor, and State employment law posters, visit our compliance hub. The documents summarize important details of the law and provide key points that you have a right to know.