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The Senior Manager, GxP Training Program & Administration at Sarepta is responsible for managing the global GxP Training Program, ensuring compliance with regulations, and serving as the training expert for various GxP areas. This role involves designing and delivering quality/regulatory compliance training, maintaining training SOPs and materials, and collaborating with cross-functional teams to ensure sustained compliance.

Manager, QA Auditing responsible for leading compliance audits, conducting internal and external audits, managing vendor programs, maintaining audit records, and preparing reports.

Support method development, validation, and quality control activities for AAV gene therapy products at Sarepta. Devise, troubleshoot, and validate cell-based assays. Coordinate lot release for clinical and commercial AAV products. Manage quality events, data trending, and review quality documents. Supervise and train junior associates.

Assist in organizing and maintaining records, tracking spreadsheets, and transferring archive records. Compile data for internal reporting and support the local quality team in gene therapy research functions.

Seeking a motivated clinical laboratory associate to provide laboratory support, develop and validate bioanalytical assays, and analyze tissue in support of clinical trials. Responsibilities include nucleic acid and protein purification, analytical methods, reagent preparation, laboratory maintenance, and documentation. Desired qualifications include a degree in Biology, Chemistry, or related field, 1-3 years of hands-on laboratory experience, and knowledge/experience in protein quantitation, Western blot, gene expression analysis, and PCR.