Scientist I

Sarepta Therapeutics is seeking a motivated facility-dependent scientist with expertise in digital image analysis development, validation, execution, and reporting. The qualified candidate will provide scientific oversight into the development strategies and validation studies in alignment with current regulatory guidance for Bioanalytical Method Validation and relevant histology- and morphometric-based guidance. This position will lead day-to-day GCP/GLP analysis on muscle/nerve using complex histology and digital image analysis methods, ensuring the requirements of approved protocols, methods, and procedures are upheld. This position will prepare relevant sections of non-clinical and 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.

Primary responsibilities include:

Serve as subject matter expert on image analysis for preclinical and clinical method development for existing and new programs.

Support and/or lead the development through validation of histological clinical and non-clinical histology and morphometric biomarkers.

Train team members on assays, sample processing and reporting workflows.

Work closely with Quality Control and Quality Assurance to ensure compliance with appropriate regulatory guidelines, including writing and reviewing SOPs, technical reports, and publications.

Plan and implement digital imaging analysis outcomes for histology and morphometrics for non-clinical and clinical studies ensuring compliance with associated protocols, methods, and procedures.

Assist 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.

Help with assay validation protocols and reports, testing protocols and reports, and relevant sections of clinical documents about translational biomarkers (e.g., Clinical Protocols, Informed Consent, Clinical Study Reports, Investigator Brochures), and documentation for submission to regulatory agencies.

Collect and analyze morphometric data using appropriate statistical procedures, including graphs, tables, and photographs of the results.

Serve as subject matter expert on histology and morphometrics image analysis for existing and new programs.

Assists in training new employees on technical procedures as assigned in standard methods, practices, procedures, and software operations.

Work in a GLP/GCLP-compliant manner and adhere to all SOPs, methods, and policies.

Additional responsibilities as assigned.

Desired Education and Skills:

Ph.D. in biological sciences or related field with 0-3 years of postdoctoral and/or industry experience or M.S. degree in biological sciences or related field with 2+ years of relevant lab experience.

Expertise in digital image analysis algorithm development, execution, and interpretation preferred.

Experience in neuromuscular histopathology preferred.

A strong understanding of cellular and molecular biology across a wide range of technologies.

Excellent written and verbal communication skills.

Desire to work in a dynamic, fast-paced team environment and make a difference in people's lives through our innovative medicines.

Proven ability to successfully manage projects and timelines, organize/track complex information, prioritize accordingly, and the ability to quickly adjust to shifting priorities and demanding timelines when necessary.

Self-motivated with a strong work ethic and the ability to work independently and efficiently.

A solid sense of accountability and sound judgment; the highest ethical standards; and a focus on quality and attention to detail.

Experience with muscle and nerve tissue samples preferred.

Demonstrates the ability to communicate clearly across multiple parties, problem-solve complex issues, and plan and develop new procedures or policies with an initiative to complete all assignments.

Recognized by former peers, colleagues, managers, and direct reports for attributes congruent with Sarepta Values: Drive, Excellence, Resilience, Teamwork, Innovation, and Compassion.

#LI-Onsite

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

The targeted salary range for this position is $91,200 - $114,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

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.

R-02444