Sarepta Therapeutics
genetic medicine
ScientistII,TranslationalBiology
“Scientist II, Translational Biology at Sarepta Therapeutics. Skills: Molecular assays development, Biomarker development, GCLP/GLP assay development, Bioanalytical method validation, Scientific leadership. Develop and execute molecular assays. Manage the development of biomarkers for clinical trials”
What You'll Achieve.
Support for Gene Therapy, RNA, siRNA and Gene Editing programs; Support pre-clinical and clinical trials; Support clinical development decision-making; Ensure compliance with appropriate regulatory guidelines
Industry & Context.
Analytical reasoning; Creative problem-solving skills; Critical thinking; Problem-solving skills across a range of scientific disciplines
Ability to work extended hours as needed, including but not limited to weekend and holiday coverage, occasionally on short notice, Candidates must be authorized to work in the U. S.
What They're Looking For.
Must Have
M.S. degree in Biological Sciences or related field with 5+ years of relevant lab experience, Ability to execute sample handling and analysis with strict adherence to laboratory methods, and SOPs using Good Documentation Practices (GDP), Demonstrated hands-on experience in protein-based biomarker analysis and molecular biomarker analysis of biological samples, Extensive working knowledge of biomedical research methodologies, Grounding in statistical analysis methods and software, Experience with GCLP/GLP assay development, bioanalytical method validation, and testing, Proven scientific leadership when working with collaborative, multi-functional teams and troubleshooting complex laboratory processes, Excellent technical writing and communication
Nice to Have
PhD preferred with 3-5 years of work experience, Kubernetes a plus
What You'll Do.
Develop and execute molecular assays
Manage the development of biomarkers for clinical trials
Participate in development and validation of biomarker assays to support pre-clinical and clinical trials
Integrate data across platforms
and study results for presentation
Author and review methods
and regulatory document preparation
Serve as Study Director or Contributing Scientist on applicable studies
Provide scientific support for translational biology efforts
Lead and conduct GCLP/GLP clinical and non-clinical study sample analysis
Operate in a laboratory setting
Train on established methods
Execute bench experiments without supervision and direction
Train team members on assays and sample processing and reporting workflows
Complete general lab tasks
Perform preventive maintenance
Perform quality control peer review
Maintain a clean working area
Adhere to proper safety techniques and procedures
How You'll Work.
Team & Collaboration
Coordinate activities and timelines through close collaboration with project management teams, research teams, as well as cross-functional Translational Biology colleagues; Document and present complex scientific concepts and findings to diverse functional groups; Work closely with Quality Control and Quality Assurance; Working with collaborative, multi-functional teams
Communication Scope
Excellent technical writing and communication; Able to articulate complex scientific concepts to diverse functional groups and external stakeholders
Process & Methodology
Coordinate activities and timelines
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