Principal Scientist, QC Software and Assay Transfer

The Principal Scientist, Product Support role will lead a variety of technical and scientific activities within Operations. This position will investigate issues through trending, troubleshooting, and root cause analysis, working closely with R&D, Quality, and Operations to design, develop, and implement corrective actions through use of the Quality Management System. This role will also serve as a subject matter expert leading Operations teams in applied chemistry/biochemistry support, new product introduction, and continuous improvement efforts.

Essential Duties

Include but are not limited to the following:

• Provide technical and product support leadership in Operations working cross-functionally with the Manufacturing Sciences, Production, QC, Supply Chain, R&D, and Quality teams.
• Lead troubleshooting of Out Of Specifications (OOS), non-conformances (NCMRs), product and process failure mode and effects analyses (FMEAs), and corrective action preventive action (CAPA) plans through root cause investigation, experiment design, study execution, data analysis, and reporting.
• Exercise subject matter expertise across diverse technical disciplines to guide key decisions within operations and on cross-functional teams.
• Clearly and accurately generate experimental protocols, draft work instruction procedures, characterize and develop test methods and test method improvements, summarizing activities through technical or investigative reports.
• Lead Operations teams for qualifying new raw materials and alternative supply channels for products.
• Provide thought leadership and mentorship.
• Analyze, track, and trend historical Production and Quality Control data.
• Program, operate, and troubleshoot complex instrumentation such as micro plate readers, Real-Time PCR instruments, and liquid handling automation.
• Oversee design and execution of complex studies, measurement systems analyses (MSAs) and designed experiments.
• Conduct bench level experiments within several product or technology areas to identify problems and discrepancies.
• Support and comply with the company's Quality Management System policies and procedures.
• Perform other related duties and special projects as assigned by management.
• Communicate to all levels within the company and thrives in a fast-paced, everchanging environment.
• Evidence of strong analytical, problem-solving skills and negotiating skills. Ability to make decisions with limited information and operate with autonomy.
• Strong documentation, attention-to-detail and procedure writing skills suitable for a GMP environment.
• Excellent oral and written communication, strong interpersonal skills.
• Demonstrated ability to develop/transfer and thoroughly document new processes and production procedures.
• Ability to interpret technical data and present findings to management.
• Ability to work in a fast paced ever changing environment.
• Strong leadership capability and excellent attention to detail to reduce errors.
• Ability to organize, present, and convey complex problems or issues within and across other functions.
• Ability to effectively work on many complex and varied projects at one time, with frequent changing priorities.
• 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.
• Regular and reliable attendance.
• Ability to work designated schedule.
• Ability to work nights and/or weekends.
• Ability to lift up to 50 pounds for approximately 5% of a typical working day.
• Ability to utilize lab equipment for 25% of a typical working day.
• Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% 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 work on a computer and phone simultaneously.
• Ability to use a telephone through a headset.
• Ability to comply with any applicable personal protective equipment requirements.
• Ability and means to travel between Madison locations.
• Ability to travel 10% of working time away from work location, may include overnight/weekend travel.

Minimum Qualifications

• Bachelor's degree in Chemistry, Molecular Biology, or Life Sciences related field.
• 16+ years of industry experience with biochemical and molecular based products.
• Proficient in Microsoft Office.
• Advanced knowledge in statistical and mathematical methods in biology/genetics, including experience with JMP software.
• Proficient in knowledge of IVD product Manufacturing processes, Product Design, and Development.
• Professional working knowledge with 21 CFR Part 820, ISO 13485, and/or cGMP structured environments.
• Authorization to work in the United States without sponsorship.
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.

Preferred Qualifications

• Master's or Ph.D. degree in Chemistry, Molecular Biology, or Life Sciences related field.
• 10+ years of experience with Medical Device Products in a Quality Control, Product Development or Product Support role.
• Experience working within Enterprise Resource Planning (ERP) systems such as SAP.
• Strong knowledge in Design for Six Sigma.
• Strong knowledge in basic and advanced continuous improvement methodologies/ principles such as LEAN Six Sigma and/or Practical Process Improvements (PPI).
• Experience with Project Management principles and practice.