Elena Webber
Digital Operations Associate @ FUJIFILM Biotechnologies
About
Biotech professional currently working at the intersection of digital manufacturing, quality systems, and cGMP operations, supporting scale-up and commercialization. In my current role, I lead the design, execution, and approval of electronic Batch Production Records (eBPRs) for a wide range of molecules, including antibodies, cell and gene therapies, lipid nanoparticles, mRNA, and antibody-drug conjugates. I also serve as Change Coordinator for change controls and deviation investigations, driving process improvements, risk mitigation, and high-quality drug delivery. Dedicated to operational excellence, with a strong interest in business strategy and product development within the life sciences industry. Contact me at elena.webber@fujifilm.com
United States
Raleigh
Primary/Secondary Education
Stakeholder Communication, Startup Environments, Regulatory Compliance, Strategic Planning, Process Improvement Implementation, Risk Assessment, Change Management, Biopharmaceutical Production, Process Optimization (Manufacturing), Good Manufacturing Practice (GMP), Workflow Optimization, Experimental Design, Project Management, Data Analysis, Requirements Gathering, Business Analysis
Experience
Digital Operations Associate
FUJIFILM Biotechnologies
Raleigh, NC
• Own end-to-end delivery of client-specific electronic batch records (eBPRs) in a GMP manufacturing environment, including coordination of the plan, client communication, and proactive escalations of risks. • Serve as SME for upstream harvest processes, supporting manufacturing readiness, tech transfer activities, and consistent execution. • Translate inputs from MFG, ENG, QA, MSAT, and AUT into compliant, execution-ready workflows. • Lead deviation investigations, CAPAs, and change management through cross-functional collaboration.
Group Fitness Instructor
The Suitcase of Courage
Research Technician I
Duke University School of Medicine
Durham, North Carolina, United States
Duke Center for Hyperbaric Medicine and Environmental Physiology. Thesis/PublicationTitle: Synaptosomal neurotransmission and bioenergetics are impacted by hyperbaric oxygen exposure in mice. Presenter at Duke Anesthesiology Academic Evening in Pod 1; awarded second place.
Fish Husbandry
Duke University Nicholas School of the Environment
Durham, North Carolina, United States
Jayasundara and Di Giulio Labs
Campus Manager
Fresh Prints
• Led client-facing projects and coordinated cross-functional order execution. • Supported demand forecasting, vendor coordination, and delivery timelines.
Undergraduate Research Assistant
Duke University Pratt School of Engineering
Durham, North Carolina, United States
Varghese Lab: Investigated alternative therapeutic approaches for pain relief and tissue regeneration post-bone fracture.
Undergraduate Research Assistant
Duke University Center for Global Women's Health Technologies
Durham, NC
Research: Investigated the combination of ECE ablation and systemic cyclophosphamide treatment induced anti-tumor effect in 4T1 TNBC murine model.
Education
Duke University
Biology, General
Graduation with Distinction
Elena Webber's Contact Information
Phone
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