Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
The Importance of the Role
Sarepta Therapeutics is seeking a motivated facility-dependent scientist with expertise in ligand-binding and PCR-based assay development, validation, execution, and reporting with a specific emphasis in siRNA therapeutics biomarker assays. The qualified candidate will provide scientific oversight into the development strategies and validation studies in alignment with current regulatory guidance for Bioanalytical Method Validation. This position will lead day-to-day GCP/GLP analysis on non-clinical and clinical samples, ensuring the requirements of approved protocols, methods, and procedures are upheld. This position will prepare relevant sections of clinical testing study reports and regulatory documents. The position includes integration of data across platforms, study metadata, and study results for presentation in meetings, reports, and regulatory documents. Additional duties include contributing to laboratory compliance and inspection readiness activities and drafting methods, SOPs, protocols, technical reports, and regulatory document preparation. This position will be a key technical point of contact for Research Operations, Clinical Operations, Data Management, Biostatistics, and vendors for data transfer and analysis needs.The Opportunity to Make a Difference
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. Laboratory compliance includes but is not limited to being up to date with the required trainings and following the laboratory cleaning and maintenance SOP.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. This includes maintaining sample testing trackers, summary statistics for reports, and testing metrics.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.More about You
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.Experience with project and data management software (MS Project, WorkFront, PowerBI, etc.) is a plus.What Now?
We’re always looking for solution-oriented, critical thinkers.
So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.