This individual will support routine testing conducted at Sarepta Andover laboratory charged with the execution of Nucleic Acids Testing (release and stability) related to Sarepta' s Gene Therapy pipeline conducted internally. The individual will conduct GMP QC release and stability testing using state of art Quantitative Polymerase Chain Reaction, qPCR, Droplet Digital PC

This position will be responsible and accountable for leading the Global Program Team (GPT) to create and execute an integrated development strategy which coherently integrates the clinical, non clinical, regulatory, medical affairs, manufacturing, commercial, and market access plans to support successful submissions, approvals, launch, and life cycle activities. It will c

The Associate Director of Finance Inventory and Manufacturing Operations will be responsible for managing the execution of processes aimed at delivering performance based analytics within the Technical Operations organization. Key duties include managing the product costing process to support strategic business planning, standard costing, and the annual business planning c

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

The Associate Director, QC Cell Culture and Bioassay will be responsible for overseeing a testing laboratory charged with the execution of all GMP bioassay testing (release and stability) related to Sarepta' s Gene Therapy pipeline. The Associate Director will build and oversee a team of eight to ten QC technicians with responsibilities that include but are not limited to

The Finished Goods Lead of Quality Assurance Operations would perform the person in plant oversight for Sarepta quality operations (for clinical and commercial) related to Gene Therapy CMOs. This person will oversee on site batch record review with on the floor support at the Philadelphia facility and perform product disposition activities. They would provide oversight of

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 Duchenne Area Manager (DAM) is a performance driven individual contributor that promotes the safe and effective use of Sarepta Therapies to medical providers across their assigned territory. This role serves as part of a larger team that forge opportunities for newly approved classes of drugs to treat Duchenne Muscular Dystrophy, a rare life threatening pediatric disea

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

Sarepta Therapeutics is seeking a motivated 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 in compliance with all relevan

As a member of the Analytical Development group this position is responsible for performing GLP method validation and GLP analytical assay support for early stage research programs. The individual will collaborate with Early Research Process Development, Gene Therapy Research, and additional internal and external stakeholders to support nonclinical GLP studies. Primary Res

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 hi

The Senior MSL will play a pivotal role in the education of healthcare professionals (HCPs) about Duchenne Muscular Dystrophy and Limb Girdle Muscular Dystrophy as well as Sarepta's investigational therapeutics and product pipeline. Reporting to the West Region Team Leader, the Senior MSL position will play a pivotal role in the education of healthcare professionals (HCPs)

The Data Scientist, Research Sciences role at Sarepta is an exciting opportunity for someone with strong data science and analytical skills who wants to see their work directly impacting patient care. In this hands on role, the data scientist will research and develop advanced analytical methods to utilize internal and external chemistry and biological data to support all

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,