Scientist I, Quality Control

This individual will support method development, validation, and quality control activities conducted at Sarepta Andover in compliance with cGMP regulations. The individual will devise, troubleshoot, and validate cell-based assays to assess the critical quality attributes of AAV gene therapy products including potency and infectivity. This role would facilitate activities to coordinate the lot release of samples for early/late phase clinical and commercial AAV therapeutic products.

The incumbent will be involved in the design and execution of novel cell-based assays, writing technical reports, supporting method validation and qualification activities performed in the Sarepta Gene Therapy QC laboratories and/or at contract testing laboratories. The individual will also assist in managing quality events, data trending, and review of quality documents originated at the testing laboratory at Sarepta. Additional responsibilities may include supervising and training junior QC associates as well as the management of their performance.

Primary responsibilities include –

• Development and validation of cell-based assays to interrogate the potency of AAV gene therapy products
• Perform testing of release and stability samples for early and late phase clinical and commercial lots
• Support troubleshooting and optimization of cell and molecular assays, including assay development & validations in accordance with cGMP regulations
• Manage activities related to cell banking and managing cell supplies at Andover or external testing 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
• 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
• Training and mentoring junior associates on the execution and analysis of cell-based assays

Desired Education and Skills: 

• PhD degree in molecular biology, cell biology or virology with 0 - 3 years relevant experience
• Experience in developing, validating, optimizing and deploying cell-based assays is highly desired
• Strong background in gene expression analysis including qRT-PCR, ddPCR, and immunoassays such as Jess capillary electrophoresis, ELISA, immunoblotting
• Familiarity with primary mammalian cell culture, in particular myoblasts, and a deep understanding of cellular differentiation and commitment
• Operate as a part of a team with experience supervising and/or training individuals in a laboratory environment
• Working experience in a cGMP environment is highly desired
• Experience in general laboratory organization, experimental design, and documentation (GDP) with adherence to cGMP is necessary
• Effective written and verbal communication skills; attention to detail is a must

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.