Lead Associate, Quality Control, Gene Therapy at Sarepta Therapeutics in andover, Massachusetts

Job Description:

The Position:
This individual will support Analytical Development and Quality Control activities conducted at Sarepta Andover facility in the field of AAV therapeutic release and stability. The individual will be responsible for internal analytical development, validation, and testing of ddPCR and qPCR- based methods. The individual will also act as company liaison with CMOs to coordinate method development and method transfer for ddPCR and qPCR-based Gene Therapy test methods. The individual will support the review of release and stability data, writing technical reports, data trending, and assist in managing quality events (OOS, OOT, Deviation, Change Control, etc). All aspects of this position would involve working in a GMP compliant manner.

Primary Responsibilities Include:

• Lead the analytical development and qualification/validation activities associated with ddPCR and qPCR-based Gene Therapy test methods.


• Conduct Nanodrop UV/Vis and Agarose Gel testing to qualify ddPCR standards and support stability studies.


• Act as company liaison with CMOs to coordinate method development and method transfer. Provide CMO support for ddPCR and qPCR-based Gene Therapy test methods as needed.


• Maintain clear and concise lab records and documentation.


• Support training of junior associates in ddPCR and qPCR-based Gene Therapy test methods as needed.


• Assist in writing and reviewing quality documents such as SOPs, development reports, study protocols, validation reports, OOS/OOT, CAPA or Change Controls.


• Evaluate CRO/CMO documentation and results as needed.


• Design, screen, and document PCR primer/probes to be used in quantification of viral vectors as needed.


• 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 with 5-8 years relevant experience.


• Working experience in a cGMP environment is preferred.


• A strong understanding of qPCR or ddPCR methods is necessary


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


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


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


• Must have effective written and verbal communication skills.


• Operate as part of a team; assisting fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency.

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.