Sarepta Therapeutics · 6 hours ago
Associate Director, Gene Therapy Quality Control Operations
Bedford, MA
Full-time
Onsite
Lead/Staff, Director/Executive
$161K/yr - $201K/yr
8+ years expSarepta Therapeutics is a leader in genetic medicine, focusing on therapies for Duchenne muscular dystrophy and other diseases. The Associate Director of QC Operations will support laboratory operations, manage inventory and procurement, and ensure compliance with regulatory guidelines while supervising laboratory personnel.
BiotechnologyGeneticsHealth CareTherapeutics
No H1B
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
Qualification
Required
MS/BS in Molecular Biology, Biochemistry, Chemistry with 8+ years relevant industry experience required
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
Self-starter with the ability to work in a fast-paced, cross-functional, highly collaborative environment
Preferred
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
Laboratory expansion experience is beneficial
Benefits
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
A competitive compensation and benefit package
Company
Sarepta Therapeutics
Sarepta Therapeutics focuses on the discovery and development of precision genetic medicine to treat rare diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.88BKey Investors
Michael Andrew ChambersPharmakon AdvisorsMidCap Financial
2025-12-11Post Ipo Debt· $291.4M
2025-08-21Post Ipo Equity
2025-08-21Post Ipo Debt· $602M
Leadership Team
Ian Estepan
Executive Vice President, Chief Financial Officer
K
Kathy Behrens Wilsey
Director
Recent News
2026-01-24
Genetic Engineering News
2026-01-23
Company data provided by crunchbase