Senior Associate – Gene Therapy Quality Control

Senior Associate – Gene Therapy Quality Control

Requirements

• B.S. or M.S. degree in molecular biology, cell biology or virology with at least 5-8 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.
• Experience in general laboratory experimentation, documentation with adherence to cGMP is necessary.
• Must have effective written and verbal communication skills.

Responsibilities

• Review protocols, testing, reports, and CoA/CoTs for release and stability of AAV based gene therapy products.
• 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.
• 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.
• Author and review test methods, development reports, study protocols, and validation reports.
• Perform other related duties incidental to the work described.

Preferred Qualifications

• A familiarity with compendial (USP, ICH, EP) guidance is highly desired.
• Experience in developing, validating, and deploying molecular biology test methods is useful.