Associate Director, Gene Therapy Quality Control Operations

Role Summary

Reporting to the Sr. Director of QC Operations, the Associate Director of QC Operations leads the internal ddPCR, qPCR, and cell-based assay operations, ensuring safety, compliance, and qualification/maintenance of laboratory instrumentation and facilities. The role includes inventory management, raw material procurement, and qualification/bridging of critical reagents to support internal and external testing at CMO/CTL partners. The Associate Director supervises laboratory operations personnel and optimizes resource allocation to ensure activities occur in an efficient, safe, timely, and cGMP-compliant manner.

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

• Required: MS/BS in Molecular Biology, Biochemistry, Chemistry with 8+ years relevant industry experience
• Preferred: Direct working experience in AAV products
• Preferred: Extensive technical expertise with gene expression analysis including qRT-PCR, ddPCR, and immunoassays such as Jess capillary electrophoresis, ELISA, immunoblotting
• Preferred: Experience operating liquid handlers
• Preferred: Proven ability to balance conflicting priorities across multiple programs, and to make sound recommendations for trade-offs to achieve aligned objectives
• Preferred: Strong interpersonal skills and a proven ability to communicate effectively through verbal and written formats
• Preferred: Laboratory expansion experience is beneficial
• Preferred: Self-starter with the ability to work in a fast-paced, cross-functional, highly collaborative environment

Additional Requirements

• This position requires on-site work at Sarepta facilities in the United States
• Candidates must be authorized to work in the United States