• Partner cross-functionally to support and lead troubleshooting of OOSs, NCMRs, and CAPAs through root cause analysis, experimental design, data analysis, and reporting.
• Support and lead investigations of complex assays, equipment, materials and processes.
• Analyze and trend historical data using statistical process control techniques to inform decision-making and process optimization.
• Support material evaluations and sourcing decisions.
• Program, operate, and troubleshoot complex instrumentation (e.g., micro plate readers, real-time PCR instruments, liquid handling automation, and next-generation sequencers).
• Author and review protocols, procedures, test methods, and technical reports.
• Support characterization of assay and formulation variability using MSA and DOE principles.
• Assist in the training and transfer of processes and/or procedures as part of corrective action implementation. 
• Communicate complex findings clearly to both technical and non-technical audiences.

Expectations

• Deliver on commitments and support timeline adherence.
• Collaborate effectively across teams and functions.
• 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.
• Ability to lift up to 50 pounds occasionally.
• Comfortable working at a lab bench or on a computer for most of the day.
• Ability and means to travel between Madison locations.
• Travel up to 5% (may include occasional overnight/weekend travel).
• Ability to utilize lab equipment for approximately 75% 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 60% 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 comply with any applicable personal protective equipment requirements. 
• Ability to work with blood, tissue, stool, or other human specimen samples. 

• Master’s degree in life sciences, or related field; or Bachelor’s degree in life sciences, or related field, and 2 years of relevant experience as outlined in the essential duties in lieu of Master’s degree.  
• 2+ years of experience in the biotech industry. 
• 2+ years of hands-on experience in molecular biology and biochemical techniques. 
• Advanced knowledge of statistical and mathematical methods in biology/genetics, including experience with JMP software. 
• Demonstrated understanding of IVD product manufacturing processes and biochemical, molecular, and real-time PCR Assays. 
• Demonstrated ability to apply common laboratory skills and techniques; including a base knowledge in chemistry, biochemistry, molecular biology, or a related field.   
• Authorization to work in the United States without sponsorship.  
• Demonstrated ability to perform the Essential Duties of the position with or without accommodation.  

• Minimum of 5 years of experience in IVD product development, design transfer, manufacturing, or product support.
• Proven ability to lead technical investigations involving complex assays and manufacturing processes.
• Strong proficiency in experimental design and data analysis generating evidence-based conclusions.
• Hands-on experience with statistical analysis tools and techniques, particularly using software such as JMP.
• Familiarity with continuous improvement methodologies, project management practices, and electronic quality management systems (EQMS), with preference for Agile and/or Oracle Cloud platforms.
• Applied knowledge of regulatory frameworks including 21 CFR Part 820, ISO 13485, and cGMP standards.
• Experience implementing formal continuous improvement systems such as A3-problem solving, value stream analysis, and kaizen blitz initiatives.