Senior Associate, Gene Therapy Quality Control

The Position: 

This individual will support Quality Control activities and act as company liaison with CMOs/CTLs to support analytical method validation/qualification and/or method transfers for AAV-based Gene Therapy Products. An understanding of ddPCR/qPCR, SDS-PAGE, and other genetic or biochemical methods performed to release AAV Gene Therapy products is preferred. Working experience in a cGMP environment is preferred. 

The individual will also support the review of CMO release and stability data, writing technical reports, data trending, and assist in managing quality events (OOS, OOT, Deviation, Change Control, etc). All aspects of this position would involve working in a GMP compliant manner.  
 

Primary Responsibilities Include: 

• Act as company liaison with CMOs to coordinate method qualification/validation and method transfer. Provide CMO support for ddPCR, qPCR and SDS-PAGE based Gene Therapy test methods as needed. 
• Evaluate and review CMO documentation and data packages as needed. 
• Conduct Nanodrop UV/Vis and Agarose Gel testing to qualify ddPCR plasmid standards and support stability studies. 
• Perform analytical development of Agarose gel-based test methods and author development reports/qualification reports. 
• Maintain clear and concise lab records and documentation. 
• Support training of junior associates in ddPCR-based test methods. 
• Assist in writing and reviewing quality documents such as SOPs, development reports, study protocols, validation reports, OOS/OOT, CAPA or Change Controls. 
• 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 4-5+ years relevant experience. 
• Working experience in a cGMP environment is preferred. 
• A strong understanding of qPCR or ddPCR methods is necessary 
• Experience in general laboratory experimentation, documentation with adherence to cGMP is necessary. 
• Experience in developing, validating and deploying molecular biology test methods is desired. 
• Must have effective written and verbal communication skills. 
• Operate as part of a team; assisting fellow lab associates in providing a functional, safe working environment while maximizing laboratory efficiency.