Lead Scientist Design Transfer

Exact Sciences • Madison, WI

1d • Onsite

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

• 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.

Responsibilities

• 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 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.

Benefits

• paid time off (including days for vacation, holidays, volunteering, and personal time)
• paid leave for parents and caregivers
• a retirement savings plan
• wellness support
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 1,001-5,000 employees