The 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 MSL position 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'...
The Sarepta Therapeutics QA Compliance Unit is seeking to fill a Full-Time position for Manager, Quality Engineer to develop and maintain GxP quality systems processes and procedures to drive quality compliance and business efficiencies. Develop and maintain processes to facilitate QMS record completion through overseeing and enabling proper investigation including problem understanding, true root cause identification and effective CAPA to preven...
This individual will be a member of the local quality team that supports preclinical and clinical gene therapy research functions. This individual will be responsible for assisting with the maintenance of the local archives, electronic, paper, and other records. Primary Responsibilities Include. Assist with organizing, tracking, correcting, filing, and cataloging records. Assist with generating and updating tracking spreadsheets for various recor...
The Real World Evidence (RWE) lead provides clinical leadership for evidence generation activities, supporting the integration of RWE into Sarepta key strategic initiatives. The role functions in a company matrix team environment interacting with several key stakeholder groups including. Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Manufacturing, Commercial, Medical Affairs, Research and Legal. Primary Responsib...
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 insights and guidance for the development of potential commercial activities and d...
The Scientist I, Bioinformatics works closely with several groups within Sarepta's Research and Development department. The Scientist I, Bioinformatics is part of the Genomics and Data Sciences team and plays a critical role in supporting Discovery Biology to advance our portfolio of RNA, gene therapy, and CRISPR-based gene editing therapies to treat neuromuscular and CNS-related disease. As such, this person is expected to communicate effectivel...
The Real World Evidence (RWE) lead provides clinical leadership for evidence generation activities, supporting the integration of RWE into Sarepta key strategic initiatives. The role functions in a company matrix team environment interacting with several key stakeholder groups including. Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality Assurance, Manufacturing, Commercial, Medical Affairs, Research and Legal. Primary Responsib...
The QC Data Manger will be responsible for overseeing review for accuracy and interpretation of data generated internally from testing laboratory charged with the execution of all GMP bioassay and Nucleic Acids Testing (release and stability) related to Sarepta's Gene Therapy pipeline. The Data Manager will be responsible for oversight and review of release and stability data, technical reports (analytical method validation and qualification repo...
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 success for clinical and commercial therapeutic programs. Develops and delive...
Sarepta Therapeutics is looking for an energetic and resourceful HR Informations Systems Technical Analyst. As an HRIS IT Technical Analyst, you will play a crucial role in supporting and optimizing our Human Resource Information System (HRIS), with a specific focus on Workday. Your expertise will be essential in ensuring smooth system operations, data integrity, and effective integration with other software and modules. You’ll collaborate closel...
This individual will be a member of the local quality team that supports preclinical and clinical gene therapy research functions. This individual will be responsible for assisting with the maintenance of the local archives, electronic, paper, and other records. Primary Responsibilities Include. Assist with organizing, tracking, correcting, filing, and cataloging records. Assist with generating and updating tracking spreadsheets for various recor...
We are seeking a hands-on team player who enjoys collaborating with colleagues and shares a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. The candidate in this role will be supporting method transfer from the analytical development group and the establishment of cell-based assays in the process analytics laboratory. Technical proficiency in analytical methodologies (cell-based assays, qPCR, ...
