Advanced Research Associate - Chemistry

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.

Pay Range:

$52,000.00 - $85,600.00

Position Summary:

Responsible for developing controls, calibrators, working solutions, and intermediates according to approved standard operating procedures. Responsible for developing quality products on schedule. General knowledge and basic application of concepts, theories, terminology and practices that apply to research in a laboratory environment.

Duties and Responsibilities:

Research Associate

• • Develop and manufacture OEM diagnostic controls and calibrators for clinical chemistry and immunoassay applications including Cardiac Markers, Immunochemistry, Lipids, Urinalysis, Coagulation, Tumor Markers, and other protein or small molecule analytes. 
  • Support new product development by assisting with formulation development, optimization, and refinement of existing products. 
  • Execute manufacturing and development procedures in accordance with approved SOPs, while maintaining complete, accurate, and contemporaneous GMP documentation. 
  • Design and execute controlled experiments to support troubleshooting, root cause analysis, process optimization, and formulation development. 
  • Prepare technical summaries and reports to support design control activities, including feasibility, development, validation, and transfer documentation. 
  • Design, validate, and transfer product formulations in compliance with design control and change management requirements. 
  • Perform inprocess testing, calculations, and adjustments to ensure analytes meet defined specifications. 
  • Analyze raw materials, intermediates, and final products using both automated and manual analytical instrumentation. 
  • Verify that analytical instrumentation, clinical chemistry analyzers, and pointofcare devices are operating correctly; perform or confirm calibration and maintenance prior to use as required. 
  • Accurately measure and prepare solutions using volumetric and gravimetric techniques, applying knowledge of chemical and biochemical properties and safe handling practices. 
  • Author, review, and revise SOPs, work instructions, QCRs, and related quality documentation; implement changes through formal change control processes. 
  • Perform manufacturing and processing steps such as centrifugation, filtration, diafiltration, column separation, and buffer exchanges as required. 
  • Design, execute, and analyze stability studies for new and existing products, including data trending and reporting. 
  • Perform aseptic techniques including sterile filtration, filling, capping, and microbial plating in accordance with GMP requirements. 
  • Support equipment and process validation activities including IQ/OQ/PQ testing. 
  • Assist with technical transfer of products and processes to manufacturing or operations teams, including training support as needed. 
  • Contribute to continuous improvement initiatives aimed at increasing efficiency, robustness, and cost effectiveness. 
  • Maintain laboratory cleanliness, organization, and equipment readiness in compliance with safety and quality standards. 
  • Participate in special projects and perform additional duties as assigned.