Primary Responsibilities Include:

• Conduct GCP/GLP clinical and non-clinical study sample analysis using a variety of assay formats such as ELISA, PCR, Western blot, and IHC according to standard operating procedures, methods and protocols.
• Support the development and validation of molecular fit-for-purpose clinical and non-clinical biomarkers following the FDA Bioanalytical Method Validation guidance.
• Operate in a laboratory setting at the Sarepta in-house laboratory as part of a team, train on established methods, execute bench experiments with minimal supervision and direction.
• Train team members on assays and sample processing and reporting workflows.
• Coordinate activities and timelines through close collaboration with project management teams, research teams, as well as cross-functional Translational Biology colleagues. This includes maintaining sample testing trackers, summary statistics for reports, and testing metrics.
• Draft assay validation protocols and reports, testing protocols and reports, relevant sections of clinical documents pertaining to translational biomarkers (e.g. Clinical Protocols, Informed Consent, Clinical Study Reports, Investigator Brochures) and documentation for submission to regulatory agencies.
• Document and present complex scientific concepts and findings to diverse functional groups.
• Work closely with Quality Control and Quality Assurance to ensure compliance with appropriate regulatory guidelines, such as writing and reviewing SOPs, technical reports and publications.
• Processes tissue, blood, urine, and other samples as needed.
• Support non-clinical necropsy and tissue processing.
• Additional duties include completing general lab tasks, preventive maintenance, and quality control peer review. Maintaining a clean working area and adheres to proper safety techniques and procedures. Performs miscellaneous related duties, as required.

• Ensure compliance with relevant regulatory guidelines.
• Ability to work extended hours as needed, including but not limited to weekend and holiday
  coverage, occasionally on short notice

Desired Education and Skills:

• Advanced degree in a scientific discipline required. M.S. degree in Biological Sciences or related field with 5+ years relevant lab experience. PhD preferred with 0-3 years of work 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.
• A strong record of demonstrating analytical reasoning and creative problem-solving skills, critical thinking including a strong grounding in statistical analysis methods and software.
• Technically proficient, strategic and collaborative with strong scientific creativity, affinity for technology and problem-solving skills across a range of scientific disciplines.
• Experience with GCP/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 skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders.
• Desire to work in a dynamic, fast-paced, high functioning and collaborative team environment and to make a difference in the lives of people through innovative medicines

This position requires work on site at one of Sarepta's facilities in the United States.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.