Elizabeth Sullivan
Site Head Moderna | CMC Strategist | Builder of High Performing Teams | Translating Vision into Regulatory-Approved Reality
- Role
- Int Site Head, Executive Director of Operations at Moderna
- Location
- Norwood, MA, US
- LinkedIn followers
- 500 followers
About Elizabeth Sullivan
Biotech is complex. I simplify it, scale it, and lead teams through it — from IND to approval.I’m a biotech executive with a deep passion for leading through transformation — of people, processes, and platforms. From mRNA to gene therapy and monoclonal antibodies, I’ve built and scaled operations that not only meet regulatory rigor but accelerate innovation. I also love to learn; I’m currently obsessed with AI and how it can be a partner for excellence.My track record includes standing up a 600+ person clinical manufacturing plant at Moderna for a personized cancer therapy, slashing cycle time by 15%, and delivering hundreds of batches for a Phase 3 clinical trial — in under 30 months. At AveXis, I led the creation of a manufacturing organization that helped bring Zolgensma, one of the first gene therapies, to market — from greenfield to FDA approval in <36 months.I deliver results — implementing systems fast, driving major cost savings, and tightening operations. But what makes it meaningful is building the teams who drive that success forward. I believe in intentional leadership — mentoring emerging leaders, empowering teams to make smart decisions, and creating cultures where accountability and collaboration thrive. Success isn\'t just hitting milestones; it’s helping others rise while we build something that lasts.Skills include: CMC Strategy | Line Management | GMP | Manufacturing | Validation | CDMO | CAPA | Tech Transfer | Continuous Improvement | AI | Budgeting | Contract Manufacturing | Planning | CRM | Negotiations | Building Teams | Collaboration | Change Management | SOP | 21 CFR part 11 Regulation | Quality | Warehouse Management | KPI
Experience
Int Site Head, Executive Director of Operations
Jan 2023 — Present · Norwood, MA, US
Lead clinical manufacturing operations for individualized neoantigen therapy (INT). Ensure end to end clinical demand is met consistently and compliantly.
Education
Penn State University
BS, Biology
1997 — 2001
Skills
- Quality System
- V&V
- Biotechnology
- Computer System Validation
- Pharmaceutical Industry
- Sop
- Fda
- Change Control
- Technology Transfer
- Gmp
- Regulatory Affairs
- Lifesciences
- Cell Culture
- Life Sciences
- Validation
- Standard Operating Procedure (Sop)
- 21 Cfr Part 11
- Capa
- Biopharmaceuticals
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