QCTS Scientist I

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

This individual will work with a team engaged in providing technical services on biophysical assays (AUC/DLS/SDS-PAGE/CE-SDS). The individual will support the training and method transfer activities related to these methods being performed at Andover, MA. The candidate must have hands-on experience in biophysical assays listed above, sample preparation, data analysis, method optimization and troubleshooting, as needed. 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.

• Perform all associated lab work for execution of biophysical assays (AUC/DLS/SDS-PAGE/CE-SDS).
• Optimize, train, troubleshoot, and perform biophysical assays.
• Work within multi-disciplinary project teams & act as a lead 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.
• Responsible for project driven initiatives that will require scientific exploration & experimentation as well as close collaboration with scientists across the organization.
• 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.

• 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 biophysical methods.
• Experience in developing, validating, optimizing and deploying viral vector analytics is highly desired.
• Be a hands-on presence in the laboratory, supporting biophysical assay transfer and validation.
• 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.
• Operate as a part of a team with experience in coordinating and collaborating with peers.
• Effective written and verbal communication skills; attention to detail is a must.

#LI-Onsite #LI-TD1 This position requires work on site at one of Sarepta’s facilities in the United States. The targeted salary range for this position is $100,000 - $125,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. 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.