Primary Responsibilities Include:

• Designs and performs method validations and analytical testing to support release and stability testing of AAV based gene therapy products
• Perform Quantitative Polymerase Chain Reaction (qPCR), Droplet Digital PCR (ddPCR), Immunoassays, In Vitro Potency, and additional AAV characterization assays
• Works seamlessly with cross functional stakeholders
• Participates in project related teams and other internal/external collaborations
• Ensures that scientific and technical challenges are resolved in a timely manner
• Maintains all appropriate laboratory records and authors Standard Operating Procedures (SOPs), technical documents, protocols, methods, and reports
• Performs routine data analysis and visualization for use in presentations, publications, and internal reports
• Contributes to a safe, efficient, and effective environment with personal accountability
• Performs other related duties as required

Desired Education and Skills:

• AS degree in scientific discipline with 8+ years of experience, BS degree in scientific discipline with 5+ years of experience, or MS degree in scientific discipline with 3+ years of experience in the biotech/pharmaceutical industry
• 3+ years of relevant industry experience in method development, validation, and analysis performing cell and molecular assay techniques (e.g., qPCR, ddPCR, CE, ELISA, cell culture, TCID50)
• Experience working in a regulated (GLP / GMP) environment
• Understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to analytical method validation and testing for gene therapies
• Excellent written and verbal communication skills
• Proven record of successfully planning experiments and executing projects in collaboration with internal or external stakeholders
• Proven ability to work independently and effectively handle multiple priorities is a must
• Ability to maintain confidentiality of proprietary information expected

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This position requires work on site at one of Sarepta's facilities in the United States.

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.