Skip to content
Scientist II – Translational Biology
| Company | Sarepta |
|---|
| Location | Columbus, OH, USA |
|---|
| Salary | $102800 – $128500 |
|---|
| Type | Full-Time |
|---|
| Degrees | Bachelor’s |
|---|
| Experience Level | Mid Level |
|---|
Requirements
- BS degree in scientific discipline/MS or Ph.D. preferred, with 3+ years of laboratory experience in the healthcare, biotech/pharmaceutical industry, or equivalent.
- Knowledge of neuromuscular biology, gene and siRNA therapies especially in the context of rare genetic disease.
- Demonstrated hands-on experience with implementation of biomarker analysis in clinical laboratory studies under regulatory guidelines.
- Laboratory experience in biomarker assay development, transfer, validation under GCP/GLP compliant conditions.
- Understanding of late-stage drug development, clinical operations and experimental design within clinical research environment.
- Proven scientific leadership when working with collaborative, multi-functional teams.
- Excellent technical writing and communication skills; able to articulate complex scientific concepts to diverse functional groups and external stakeholders.
- A strong record of demonstrating critical thinking and creative problem-solving skills.
Responsibilities
- Conduct GCP/GLP clinical study sample analysis, under the direction of project management teams, using a variety of assay formats such as PCR, IP, Western blot, IHC, and NGS while ensuring compliance with associated protocols, methods, and procedures.
- Work closely with Quality Control and Quality Assurance to ensure compliance with GDP, GCP, GLP, and appropriate regulatory guidelines, including writing and reviewing SOPs, technical reports, and publications, and maintaining compliant laboratory records.
- Contribute to laboratory compliance, inspection readiness activities, and regulatory agency-related written communications as an SME for this function.
- Take a lead role in the development and validation of fit-for-purpose bioanalytical methods for various clinical stage programs.
- Coordinate activities and timelines through close collaboration with project management teams, research teams, as well as cross-functional Translational Biology colleagues.
- Train team members on assays, sample processing, and reporting workflows.
- Organize and track complex information, prioritize accordingly, and quickly adjust to shifting priorities and demanding timelines to support the overall goals of the department.
- Work extended hours as needed, including but not limited to weekend and holiday coverage, occasionally on short notice.
Preferred Qualifications
- Experience with project and data management software (MS Project, WorkFront, PowerBI, etc.) is a plus.
