Senior Associate, Quality Control at Sarepta Therapeutics in andover, Massachusetts

Job Description:

This individual will support quality control activities conducted at Sarepta Andover in compliance with cGMP. The individual will perform laboratory analysis involving qPCR, ddPCR, rcAAV and TCID-50 infectivity assay. Additionally, the individual will be responsible for reviewing release and stability data for AAV gene therapy batch release. The incumbent will assist in writing technical reports, supporting analytical method validation and qualification activities performed in the Sarepta QC laboratories. The individual will work with a team engaged in conducting rcAAV and TCID50 assays in support of release and stability of commercial AAV therapeutic products. This individual will assist in troubleshooting the rcAAV and TCID-50 assays being conducted in Andover, MA and at contract testing laboratories. The individual will perform assays, compile data and assist in the review of the data. The individual will also assist in managing quality events, data trending, review of quality documents originated at the testing laboratory at Sarepta. All aspects of this position would involve working in a GMP compliant manner.

Primary Responsibilities Include:

• Perform laboratory analysis using qPCR, ddPCR rcAAV and TCID-50 methodology described above.


• Test and release clinical lots and commercial lots.


• Manage activities related to cell banking and managing cell supplies at Andover or external testing sites.


• Perform plasmid linearization and qualification as standards for use in the PCR methods.


• Manage activities related to reference standard qualification and supply to external sites


• Author test methods, development reports, study protocols, and validation reports.


• Support the method development, transfer and qualification/validation activities associated with the release of viral vector products.


• Author and review quality documents such as SOP, OOS/OOT, CAPA and Change Control originated internally as well as at the vendor sites.


• Act as company liaison with CMO/CTL/CRO to coordinate in method development and method transfer across various CMO/CTL/CRO sites as needed


• Perform testing of release and stability samples for early and late phase clinical programs.


• Conduct review of laboratory data and authorization of final reports


• Monitor, review, and trending of stability data


• Perform other related duties incidental to the work described

Desired Education and Skills:

• B.S. or M.S. degree in molecular biology, cell biology or virology.


• 2 - 5 years relevant experience


• Working experience in a cGMP environment is preferred.


• A strong understanding of TCID-50, rcAAV, cell culture, qPCR, ddPCR, Thermocyclers, working in biological safety cabinets (BSC) and PCR enclosures is required


• Experience in general laboratory experimentation, documentation with adherence to cGMP is necessary.


• Experience in developing, validating, optimization and deploying molecular biology test methods is highly desired.


• Operate as a part of a team with experience supervising and /or training individuals in a laboratory environment.


• Attention to details is a must


• Strong organizational skills, maintaining excellent laboratory records


• Effective written and verbal communication skills


• Position may require some travel.

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.