QCTS Scientist I - Sanger Sequencing

Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limb-girdle muscular dystrophies (LGMDs), and we currently have more than 40 programs in various stages of development in gene therapy, RNA and gene editing. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
 

We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
 

What Sarepta Offers

At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:

• Physical and Emotional Wellness

• ​Financial Wellness

• Support for Caregivers
   

For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
 

The Importance of the Role

This individual will work with a team engaged in providing technical services in genomic characterization of AAV plasmids and gene therapy products using the Sanger Sequencing method. The individual will support the training and transfer activities related to the method being conducted in Andover, MA. The candidate must have hands-on experience in sequencing platforms, data analysis, method troubleshooting, as needed. Compendial method experience is highly desirable. The work involves performing assays in a QC-GMP environment and the individual will work alongside other team members to train, assess and improve assay performance and participate in method transfer, qualification and validation activities. All aspects of this position involve working in a GMP-compliant manner.
The individual will also assist in data trending and analysis, maintaining laboratory equipment, and management of materials and reagents. This position is onsite 5 days a week and requires occasional coverage late in the evening and on weekends. All positions will be based initially in Sarepta’s Andover, MA facility but will move to Sarepta’s Bedford, MA facility in the summer of 2025.

The Opportunity to Make a Difference

• Perform general molecular biology techniques including primer design, PCR, molecular cloning, plasmid DNA extraction, gel electrophoresis, and sanger sequencing.
• Optimize, train, troubleshoot, and perform sequencing assays.
• Work within multi-disciplinary project teams & act as a lead analytical & molecular biology resource to guide method transfer, qualification/ validation of AAV gene therapy products.
• Support qualification of critical reagents for AAV product testing.
• Train junior team members and cross-functional teams in lab operations and lab procedures.
• Provide routine analytical characterization and testing support to partner groups including QC Operations, Upstream and Downstream PD teams.
• Responsible for utilizing verbal & written skills & the ability to clearly present scientific concepts & results for functional scientific & non-scientific leaders.
• Resolve key project challenges by effectively utilizing available analytical tools, information & technical expertise in accordance with cGMP regulations.
• Create and maintain clear, concise lab records and documentation.
• Support in authoring test methods, development reports, study protocols, and validation reports.
• 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.
• Demonstrate leadership by advising & sharing knowledge & expert opinions with peers & senior management.
• Perform other related duties incidental to the work described.

More about You

• BS or equivalent education with typically 8-10 years of experience, or MS or equivalent education with 5-8 years of experience, or PhD with 1-3 years of relevant experience in sequencing and/or molecular biology techniques.
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