Senior Associate, Gene Therapy Quality Control

This individual will work with a team engaged in providing technical services on cell-based assays (Potency assay) to support the Quality Control team for commercial lot release and stability activities. The individual will troubleshoot and support the optimization of cell and molecular biology assays being conducted in Andover, MA, and at contract testing laboratories. The candidate should have hands-on experience in In Vitro Potency, SDS-PAGE, Automated Western blot, enzyme activity measurements, protein extraction, and quantification methods. The work involves performing assays in a BSL-2 environment and the individual will work alongside other team members to assess and improve assay performance and participate in internal or external quality events on the potency method. All aspects of this position involve working in a GMP-compliant manner.
The individual will also assist in authoring/managing quality events, data trending at the testing laboratory at Sarepta and at contract testing laboratories. This individual will also be responsible for training junior QC associates. This position is onsite 5 days a week and requires occasional coverage late in the evening and a few hours on weekends.
Primary Responsibilities Include:

• Optimize cell culture conditions to support execution of cell-based assays
• Support troubleshooting and optimization of cell and molecular assays, including assay development & validations in accordance with cGMP regulations
• Prepare, qualify, and release standards for the in vitro potency methods
• Test new cell lines for use in new potency assays
• Maintaining cell banks on cryogenic storage
• Improve robustness and throughput for existing cell assays, integrating automation platforms
• Support the method development, transfer and qualification/validation activities associated with the cell-based potency assays for AAV-based Gene Therapy products
• Create and maintain clear, concise lab records and documentation
• Support in authoring test methods, development reports, study protocols, and validation reports
• Sample management: Inventory and tracking of incoming and outgoing samples
• Collaborate with team leads and managers to optimize a smooth workflow for efficient management of team activities.
• Perform other related duties incidental to the work described.

Desired Education and Skills:

• B.S. degree in molecular biology, cell biology or virology with 3-5 years relevant experience.
• A strong understanding of operating and method development using Jess/ Capillary electrophoresis western blotting.
• Working experience in a cGMP environment is required.
• A strong understanding of cell and molecular techniques including potency-based immuno-assays, ELISA, immunoblotting, and cell banking is necessary.
• Familiarity with primary mammalian cell culture, in particular myoblasts, and deep understanding of cellular differentiation and commitment
• Transductions with AAV vectors and conditions to optimize payload delivery and expression
• Experience in developing, validating, optimization and deploying cell and molecular biology test methods 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 training individuals in a laboratory environment.
• Attention to details is a must.
• Effective written and verbal communication skills.

#LI-Onsite
This position requires work on site at one of Sarepta's facilities in the United States.
The targeted salary range for this position is $88,000 - $110,000 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.