Scientist, Analytical Development Bioassays (Temporary)

What You'll Do

• Develop, optimize and qualify cell-based and binding bioassays
• Bring in new assay modalities and technology to the group as needed
• Prepare assay standards, controls, critical reagents, and ensure appropriate system suitability criteria are met
• Perform characterization testing including binding ELISA, Neutralization assays, and effector function assays to support structure-function studies, force degradation studies and BLA-enabling Process and Formulation development studies
• Troubleshoot method-related issues internally and at external labs
• Author study protocols, development/qualification reports and test methods, summarize and verify data for regulatory filings

Who You Are And What You Bring

• Bachelor's degree with 8+ years' of industry experience, Master's degree with 6+ years' of industry experience, PhD with no industry experience
• Experience in bioassay method development, transfer and qualification
• Experience in data analysis of bioassays including parallel line analysis and other statistical data analysis for evaluating method performance
• Able to execute laboratory experiments both independently and with other team members
• Effective at trouble-shooting method-related issues
• Experience working on multiple projects, adjusting quickly to changes in priorities