Gene Therapy Quality Control Associate II - Cell-Based Assays

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

This individual will work with a team engaged in providing technical services on cell-based assays (Potency assay, Infectious titer TCID50 assay). The individual will support the optimization of cell and molecular biology assays being conducted in Andover, MA and conduct laboratory support processes such as maintaining cell cultures. The candidate must have hands-on experience in cell culture techniques, in vitro Potency, Western blot (automated preferred), protein extraction, and protein quantification methods. Experience with qPCR, and/or ddPCR are also desired skills. The work involves performing assays in a QC-GMP BSL-2 environment and the individual will work alongside other team members to assess and improve assay performance and participate in 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 on-site 5 days a week and requires occasional coverage late in the evening and on weekends.

• 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 including protein and mRNA-based expression assays
• Create and maintain clear, concise lab records and documentation
• Sample management: Inventory and tracking of incoming and outgoing samples
• Collaborate with team leads and managers to optimize a smooth workflow for collaboration on team activities
• Perform other related duties incidental to the work described

• B.S. degree in molecular biology, cell biology or virology with 2-3 years relevant experience.
• Understanding of operating and method development using Jess/ Capillary electrophoresis western blotting.
• Working experience in a cGMP environment is required.
• An understanding of molecular techniques including potency-based immuno-assays, ELISA, immunoblotting, qPCR, ddPCR, and cell banking is necessary.
• Hands on experience running protein-based immunoassays and/or qPCR/ddPCR assays.
• Familiarity with primary mammalian cell culture, in particular myoblasts.
• 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 coordinating and collaborating with peers.
• Attention to details is a must.
• Effective written and verbal communication skills.

#LI-Onsite #LI-ES1 This position requires work on site at one of Sarepta’s facilities in the United States. The targeted salary range for this position is $60,000 - $75,000 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.