Analytical Development Research Scientist

Job Description

General Summary:

The Analytical Development Research Scientist works with a high degree of independence and is adept at designing and executing complex experimental procedures within required timelines. Completes work in a resourceful, self-sufficient manner and is able to troubleshoot and design alternative approaches to achieve desired outcomes. Performs strategic planning consistent with regulatory guidance, implements innovative approaches and maintains a high level of technical knowledge. Authors and reviews method documents, analytical study protocols and reports. Works collaboratively within the analytical development team and cross-functionally with other groups to meet CMC organizational goals. This is a hands-on role combining advanced data analytics with laboratory-based assay development in a cross-functional setting.

Key Duties and Responsibilities:

• Independently conceptualize, develop, and deploy analytical solutions that support characterization of cell-based products
• Perform laboratory experiments supporting analytical method development for gene and cell therapy products, and apply statistical analyses to assess specificity, sensitivity, linear range, precision, and accuracy
• Analyze complex experimental and process data, and create clear visualizations and present findings and recommendations to technical teams and management
• Execute test methods supporting Process Development activities to support process improvements
• Author and review SOPs, protocols, technical reports, and transfer and qualification documentation, and contribute analytical content to regulatory filings
• Maintain clear, accurate, and compliant records, including electronic lab notebooks and test forms
• Stay current with developments in the broader data science community and apply relevant approaches to analytical challenges

**Knowledge and Skills:*...

Lorem ipsum dolor sit amet, consectetur adipiscing elit. Sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum.

Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium, totam rem aperiam, eaque ipsa quae ab illo inventore veritatis.