The Sr. Manager, QA Auditing will be responsible for scheduling and leading domestic and international Corporate and Regional Compliance Audits, including internal audits of Sarepta GxP facilities and external audits of Sarepta approved vendors in accordance with Sarepta policies and procedures. He/she will proactively identify compliance risks and communicate to Sarepta l

The Manager, Contracts Review will provide a broad array of key support to the organization as it continues to grow its development pipeline and moves into later stage clinical development and commercialization. As a critical contributor to Sarepta's legal function, the Manager, Contracts Review will have frequent interactions with internal stakeholders across multiple fun

The Senior Director of Technical Innovation requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen. This leader will drive technical innovation by both enhancing and leveraging our Technical Operations capabilities to maintain our position as a world leader and change driver in the in

This individual will provide laboratory support, perform experiments, collect and analyze data on in vivo studies to investigate gene therapies for rare genetic diseases. Activities will include assessment of protein expression, tissue pathology, and disease phenotype in animal models of neuromuscular disorders. Additionally, the individual will participate in the developm

This individual will support analytical development activities conducted at Sarepta Andover facility in the field of in vitro potency of AAV based Drug products. The individual will help in the development and validation of cell based in vitro potency assays. The position requires a strong background in cell culture, sample preparation and protein analysis. The work involv

Sarepta Therapeutics is seeking a motivated facility dependent individual with histology and immunohistochemistry experience. The qualified candidate will provide laboratory support of day to day GLPs (Good Laboratory Practices) testing on muscle, nerve, and other types of tissue using complex prosecting and histology methods in accordance with the requirements of approved

The Senior Equipment Coordinator will be a member of the local equipment management team that supports preclinical and clinical gene therapy research functions. This individual will lead all aspects of equipment management for all assets at the Dublin and Columbus facilities in Ohio, including helping to procure, maintain, and document assets. The Senior Equipment Coordina

The Vivarium Animal Aide maintains a clean, compliant and well stocked facility to support preclinical gene therapy research. The Vivarium Animal Aide works directly with and assists the Animal Care Specialist, Colony Management Specialists, and Vivarium Manager in Vivarium. This position requires contact with significant animal dander that may result in sensitization to a

The Associate Director, Commercial Diagnostics & Bioinformatics reports into the Executive Director, Commercial Diagnostics and plays a key role in driving the strategic vision and objectives to make Sarepta a recognized leader in precision genetic medicine for rare diseases. The Associate Director, Commercial Diagnostics analyzes genetic diagnostic data to provide insight

This individual will support method development, validation, and quality control activities conducted at Sarepta Andover in compliance with cGMP regulations. The individual will devise, troubleshoot, and validate cell based assays to assess the critical quality attributes of AAV gene therapy products including potency and infectivity. This role would facilitate activities

This individual will join the Analytical Development team involved in the development of novel AAV Gene Therapy analytical methods. The individual will have an in depth knowledge of AAV gene therapy analytical methods that include qPCR, ddPCR, TCID50, rcAAV, SDS PAGE, CE, ELISA, AUC, FACS and potency (in vivo and in vitro). The Associate Director should have demonstrable s

Co lead the strategy and implementation of global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the interface with multiple internal and external stakeholders, including partners. Works as Global Regulatory Leads (GRLs) for assigned projects. Positively contributes to the regulatory probability of su

The RNA Research group at Sarepta Therapeutics is seeking a talented, motivated, and experienced scientist to join the dynamic and fast paced chemistry team located in Cambridge, MA. The successful candidate will work on our PMO oligonucleotide platform and discovery research on improved delivery of oligonucleotides as well as manage collaborations and CROs as needed. This

Serves as a stat programming expert or point of contact for assigned clinical studies under close/limited supervision of the stat programming project lead Primary Responsibilities Include Effectively designs and codes SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical projects(s) Produces and delivers CDISC and regulatory compliant SDTM,

The person in this position will be working with a cross functional team as the project biostatistician responsible for statistical activities at the compound level or study level for one or more Gene therapy programs. It is an excellent opportunity to work at the forefront of precision genetic medicine, making an impact to the development of transformative therapies that