Associate Director, Gene Therapy Quality Control Operations

Role Summary

Associate Director, Gene Therapy Quality Control Operations. Reports to the Sr. Director of QC Operations and leads QC activities for internal ddPCR, qPCR, and cell-based assays, ensuring laboratory safety, compliance, and equipment qualification. Responsible for inventory management, raw material procurement, and reagent qualification for internal and external testing at CMO/CTL partners, and for optimizing department resources to meet program needs in a cGMP setting.

Responsibilities

• Manage the inventory for all reference standards, assay controls and critical reagents qualification, bridging, and expiration extension
• Generate Certificate of Analysis for critical reagents in compliance with cGMP
• Monitoring KPIs associated with laboratory performance, productivity, run time and efficiency
• Establish cross-functional relationships with Sarepta CMC stakeholders to aligned goals, timelines, and resource requirements
• Establish and manage external collaborations to accomplish key Sarepta objectives
• Proactively identify opportunities to improve operational efficiency, communication, and program outcomes
• Ensures compliance with GCP, GLP and cGMP guidelines both internally at Sarepta and at contract testing laboratories
• Procure new equipment and support timelines for qualification
• Support quality events associated with Laboratory investigations, deviations, change controls, etc.
• Author regulatory submission sections and address questions from health authorities regarding critical reagents
• Manage spend through budget planning, Scope of Work requests, invoice reconciliation, and change orders

Qualifications

• Direct working experience in AAV products is highly desired.
• Extensive technical expertise with gene expression analysis including qRT-PCR, ddPCR, and immunoassays such as Jess capillary electrophoresis, ELISA, immunoblotting.
• Experience operating liquid handlers is beneficial.
• Proven ability to balance conflicting priorities across multiple programs, and to make sound recommendations for trade-offs to achieve aligned objectives.
• Strong interpersonal skills and a proven ability to communicate effectively through verbal and written formats.
• Laboratory expansion experience is beneficial
• Self-starter with the ability to work in a fast-paced, cross-functional, highly collaborative environment.

Education

• MS/BS in Molecular Biology, Biochemistry, Chemistry with 8+ years relevant industry experience

Additional Requirements

• On-site role at a Sarepta facility in the United States
• Candidates must be authorized to work in the United States