Analytical Development Research Scientis
- Boston, MA, United States
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Original job description
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-sufcient 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:
Demonstrated experience applying data science and statistical analysis to complex scientific questions Ability to independently plan and execute technical work, interpret results, and communicate conclusions to cross-functional audiences Advanced data analysis, statistical analysis (e.g. JMP,... For full info follow application link.
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