By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide. **Position Summary:** R&D Systems, a Bio-Techne brand, is seeking an outstanding Scientist with a PhD or equivalent professional experience to join our Diagnostics Assay Development group charged with developing cutting-edge assays spanning from toxicology to neuroscience. This role will lead new product initiatives to enable novel products through integration of reagents, instrumentation, analysis algorithms and software. This position will support all stages of product development, including activities such as prototype optimization, guard-banding, design lock, verification, validation, and design transfer. This position will lead key project deliverables (e.g. verification/validation plans, technical reports, design control documents, protocol guides), contribute to design control and technical risk analysis, and independently design, execute, and analyze complex experiments and large data sets to inform design decisions and risk mitigation. + Independently design and carry out experiments leading to the development of new assay products and improving existing products. + Gain understanding of various types of assay targets and support design and characterization of complex assays used in their detection. + Apply/ learn new characterization methods for the sensitive detection or quantification of multimodal biomarkers from clinical specimens or in process reagent qualification. + Lead the creation of protocols, presentations, standard operating procedures, design verification and validation procedures, quality control procedures, and technical reports to support lab infrastructure, new product initiatives, and on-market product investigations. + Contribute to design control and associated documentation for new product initiatives, including drafting of user needs, design inputs/outputs, risk analysis and mitigation, and design transfer. + Train and mentor co-workers on equipment and procedures and lead data analysis and interpretation. + Provide substantial, high-quality contributions to projects by working independently, communicating effectively within team and cross-functionally, and leveraging the active support of others. + Organize, analyze, and/or visualize complex datasets using analytical software (JMP, R, or Python) and statistical comparisons and clearly communicate results or complex scientific topics to technical and non-technical audiences. + Lead and contribute to design and execution of experimental plans or processes to support objectives within the organization. + Apply scientific methods and process design principles to improve product development and manufacturing processes. **Who You Are & What You Bring** Required: + A PhD in Immunology, chemistry, biomedical engineering, or related field or a Master’s degree plus 6-8 years of relevant industry experience. Bachelor’s degree is acceptable with 10+ years of related experience. + Prior demonstrated experience developing and validating/verifying complex assays under design control using a requirements-driven, risk-based approach within the biotech industry or clinical laboratory. + A strong track record of independence, productivity and creative problem-solving. + Expertise in one or more technology areas and considered a resource by colleagues to develop similar skills. + Demonstrated ability to independently design and implement experimental plans or processes to support objectives within the organization, including optimization and guard banding of product prototypes. + Excellent written and verbal communication skills and attention to detail. + A passion for improving patient care through diagnostic technologies. Preferred: + Proficiency with Excel, JMP, Python and/or R. + Experience with establishing DOE protocols and interpretation of the data. + Project management experience. + Experience developing regulated diagnostic tests (especially FDA-cleared). + Familiarity with standards and guidelines for validating assays (CLSI, ISO). + Ability to contribute to early-stage product prototype development where needed is a plus. + Ability to apply statistical analysis to large data sets, especially with code, is a plus. Why Join Bio-Techne: + We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one! + We invest in our employees’ financial futures through 401k matching and an employee stock purchase plan. + We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more. + We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging. + We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Bio-Techne is an E-Verify Employer in the United States. Bio-Techne empowers researchers in Life Science and Clinical Diagnostics by providing high-quality reagents, instruments, custom manufacturing, and testing services. Our family of brands creates a unique portfolio of products and services. Science is our passion; it drives us to collaborate, develop, and manufacture award-winning tools that help researchers achieve reproducible and consistent results.