Scientist II, Translational Biology

Sarepta Therapeutics•Columbus, OH

4d•Onsite

About The Position

The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. 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. Sarepta Therapeutics is seeking a motivated Scientist with laboratory experience in developing and executing molecular assays and leadership expertise to manage the development of biomarkers for clinical trials. The qualified candidate will have strong, hands-on background with molecular assays and able to execute routine assays according to the established methods and procedures. This person will also participate in development and validation of biomarker assays to support pre-clinical and clinical trials and clinical development decision-making. The position includes integration of data across platforms, study metadata, and study results for presentation in meetings, reports, and regulatory documents. They will author and review methods, SOPs, protocols, technical reports, and regulatory document preparation. They may serve as Study Director or Contributing Scientist on applicable studies.

Requirements

Advanced degree in a scientific discipline required.
M.S. degree in Biological Sciences or related field with 5+ years of relevant lab experience.
PhD preferred with 3-5 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 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 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
Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation and Compassion.
Candidates must be authorized to work in the U.S.

Responsibilities

Provide scientific support for translational biology efforts in support of Gene Therapy, RNA, siRNA and Gene Editing programs.
Lead and conduct GCLP/GLP clinical and non-clinical study sample analysis using a variety of assay formats such as ELISA, PCR, Western blot, NGS, and IHC/image analysis according to standard operating procedures, methods and protocols.
Lead and support the development and validation of 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 without 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.
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.
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
Additional responsibilities as assigned.