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Associate Director, QC Cell Culture And Bioassay
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Full-time
- The Associate Director, QC Cell Culture and Bioassay will be responsible for overseeing a testing laboratory charged with the execution of all GMP bioassay testing (release and stability) related to Sarepta' s Gene Therapy pipeline.
- The Associate Director will build and oversee a team of eight to ten QC technicians with responsibilities that include but are not limited to: aseptic cell culture, relative potency testing, infectious titer testing, and execution of replication competent vector assays.
- The AD-QC Cell Culture and Bioassays will work cross-functionally with members of the Analytical Development and QC-Technical Services (QC-TS) teams to develop, transfer, and qualify phase appropriate assays in support of the Sarepta Gene Therapy pipeline.
- Provide technical leadership and subject matter expertise to the cell culture and bioassay team to ensure the successful execution of all GMP release and stability bioassays executed in support of Sarepta' s Gene Therapy programs (currently 1 commercial program and 5+ active clinical programs).
- Track and trend all cell culture and bioassay test data and reference standard performance data.
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