The individual provides molecular biology analytical method support for on-going AAV based gene therapy products. The Scientist I will be responsible for writing and reviewing of methods/SOPs, validation protocols, reports, and analytical data generated by both external testing laboratories and Sarepta internal QC laboratories. The individual will be responsible for streamlining the test methods in the laboratory and further development/improvement of existing methods for supporting regulatory filings and clinical comparability. The person will also oversee the transfer and validation of these methods at contract testing (CTL) and contract manufacturing (CMO) sites.Primary Responsibilities Include:* Independently design, execute, direct and testing of AAV based gene therapy products.* Have a deep understanding of the test methods including qPCR, ddPCR applied for viral genome quantification and for residuals testing, infectivity test methods (TCID50), and other viral potency and viability test methods to support the manufacturing, purification and stability studies for AAV products.* Serve as liaison on the transfer and on-site validation of qPCR, ddPCR test methods, TCID50 and residual methods for AAV based products internally and t external contract test laboratories in the US and EU.* Act as company liaison with CMOs to coordinate in method development and method transfer across various CMO/CRO sites.* Evaluate CRO/CMO documentation and results as needed.* Review validation protocols, validation reports and routine QC analysis data for release and stability for clinical and commercial DS/DP.* Develop and maintain clear and concise lab records and documentation.* Author development reports, study protocols, and pre-validation reports.* Contribute to regulatory filing documents.* Perform other related duties incidental to the work described.Education and Skills Requirements:* Ph.D. degree in Virology, Molecular Biology or related field with at least 1-3 years relevant academic or industry experience.* A strong understanding of contemporary molecular biology methods with hands on experience in Gibson Assembly, cloning, and mutagenesis.* Demonstrable experience in quantitative qPCR and ddPCR is required.* A demonstrable grasp of a wide range of technologies TCID50, qPCR, ddPCR, ELISA, SDS-PAGE, as applied to gene therapy products is required.* Working in a cGMP environment and experience in writing regulatory documents desired.* Must have effective written and verbal communication skills.* Operate as part of a team; assisting fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency.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.