- Design, develop, and qualify molecular-based analytical methods, including multiplex PCR-based assays using qPCR, RT-qPCR, ddPCR, to support pipeline cell therapies.
- Provide leadership and mentorship within a team responsible for assessing new technology, developing molecular biology-based analytical methods, and managing method lifecycle.
- Prepare complex technical documents, including SOPs, test methods, study protocols, and reports.
- Ensure successful transfer of assays to quality control (QC) and commercial teams as needed.
- Establish best practices for molecular biology-based methods by intended use and phase of testing.
- Develop strategies, lead studies, and implement changes to improve existing method performance in development and QC settings to support scalability and reduce resource burden.
- Assist in investigations and troubleshoot molecular-biology based analytical methods by designing and overseeing studies and analyzing data sets with internal colleagues.
- Present development updates and communicate with project leads, project teams, QC teams, operations teams, process development teams and other internal/external collaborators, as needed.
- Analyze data and contribute to complex technical reports and team presentations.
- PhD with 2+ years of industry experience in molecular assay development, or MS/MA in Molecular Biology or similar with 5+ years of related experience, or BS/BA with 10+ years of related experience.
- Expert knowledge of and hands-on experience developing and optimizing analytical methods using molecular biology techniques, including various PCR-based methods and next-generation sequencing.
- Experience designing and executing experiments to demonstrate assay comparability and to determine assay performance, including the assessment of specificity, accuracy, precision, linearity, and robustness.
- Expert experience writing technical documents, including test methods, SOPs, study protocols, and study reports.
- Track record of successful transfer and management of analytical methods.
- Ability to work effectively and efficiently as a team player in a dynamic environment.
- Strong problem-solving ability in order to troubleshoot complex technical and scientific problems.
- Exceptional attention to detail, strong organizational skills, and a demonstrated ability to complete projects within a timeline.
- Effective communicator.
- PhD with 2+ years of industry experience in molecular assay development, or MS/MA in Molecular Biology or similar with 5+ years of related experience, or BS/BA with 10+ years of related experience.
- Design, develop, and qualify molecular-based analytical methods, including multiplex PCR-based assays using qPCR, RT-qPCR, ddPCR, to support pipeline cell therapies.
- Experience designing and executing experiments to demonstrate assay comparability and to determine assay performance, including the assessment of specificity, accuracy, precision, linearity, and robustness.
- Prepare complex technical documents, including SOPs, test methods, study protocols, and reports.
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Research Scientist - Seattle, United States - CYNET SYSTEMS
Description
Job Description:Pay Range $53hr - $56hr
Responsibilities: