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Associate Director, Quality Control Nucleic Acids Testing (NAT)
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$156,000 - $195,000 a year
Full-time
- The Associate Director of Quality Control – Nucleic Acids Testing will be responsible for overseeing a laboratory charged with the execution of all GMP Nucleic Acids Tests (release and stability) related to Sarepta’s Gene Therapy pipeline.
- The Associate Director will build and oversee a team of four to eight QC technicians with testing responsibilities that include a variety of PCR modalities (qPCR, RT-qPCR, ddPCR, and/or digital PCR).
- The AD-QC Nucleic Acids Testing (NAT) 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.
- Primary Responsibilities:Provide technical leadership and subject matter expertise to the Nucleic Acids testing team to ensure the successful execution of all GMP release and stability PCR testing executed in support of Sarepta’ s Gene Therapy programs (currently 1 commercial program and 5+ active clinical programs).
- Establish cross-functional relationships with Sarepta Analytical Development and Quality Control-Technical Services (QC-TS) teams to ensure all NAT assays introduced to QC are compliant and sufficiently robust.
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