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

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.