Nurse Reviewer jobs in Kingston, NH

This individual will support quality control activities in the field of AAV therapeutic release and stability conducted both internally at Sarepta Andover facility and at contract vendors such as contract testing laboratories (CTLs) and contract manufacturing organizations (CMOs). The work involves reviewing data gathered from routine testing as well as from validations and qualifications. The scope will also include generating certificates of analysis/testing (CoA/CoTs), standard operating procedures (SOPs), and oversight of CTLs. The individual will also assist in managing quality events (OOS, OOT, Deviation, Change Control, etc.) and data trending. All aspects of this position would involve working in a GMP compliant manner.

Primary Responsibilities Include

• Review protocols, testing, reports, and CoA/CoTs for release and stability of AAV based gene therapy products (e.g., qPCR, ddPCR, in-vitro based assays, ELISA, SDS-PAGE, HPLC, MS, and Western Blot) generated at CTLs/CMOs, and internally at Sarepta.
• Monitor, compile, and review analytical and QC data individually and with team members.
• Assist broader Analytical Development/Quality Control team with coordination of sample pulls, set downs, and tracking critical reagents.
• Create and maintain clear and concise records and documentation.
• Support the method development, transfer and qualification/validation activities associated with the release of bacterial plasmids, viral vector products, critical reagents and reference material.
• Trend data for qualified materials, release products, and stability products.
• Assist in writing and reviewing 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 CMOs to coordinate in method development, method transfer, and release and stability testing across various CMO/CRO sites as needed.
• Author and review test methods, development reports, study protocols, and validation reports.
• Perform other related duties incidental to the work described.
  
  

Desired Education And Skills

• B.S. or M.S. degree in molecular biology, cell biology or virology with at least 2-5 years relevant experience.
• Working experience in a cGMP environment is preferred.
• A strong understanding of cell culture methods, polymerase chain reaction (PCR,) agarose gel electrophoresis, SDS-PAGE electrophoresis, ELISA, and spectrophotometric assays.
• A familiarity with compendial (USP, ICH, EP) guidance is highly desired.
• Experience in general laboratory experimentation, documentation with adherence to cGMP is necessary.
• Experience in developing, validating, and deploying molecular biology test methods is useful.
• Must have effective written and verbal communication skills.
• Operate as part of a team, assisting associates in providing a functional, safe working environment while maximizing laboratory efficiency.
  
  

This position requires work on site at one of Sarepta’s facilities in the United States.