Verified recordBiotechnology Research

Stephanie Saddic

Executive Director, Cmc Project Management at Aura Biosciences

Based in Chester Springs, United States

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Seniority

C-Team

Department

General Business & Management

Location

Chester Springs

Industry

Biotechnology Research

Company size

125

Contact information

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Email

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s•••••••@aurabiosciences.com

Phone

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Background

About Stephanie Saddic

I am an acommplished CMC Program Leader with 15+ years experience in cell and gene therapy and biotech specializing in leading complex matrix teams through drug development including late stage assets. I have lead end to end operations from manufacturing of raw materials through to clinical trial supply and distribution of drug and device to patients in time for surgical procedures. By understanding the big picture, having the ability to multi-task and prioritizing workload, I have been successful in delivering CMC activities to meet critical program milestones. My strengths are problem solving, building solid working relationships, wearing many hats and getting into the details when necessary. Key Competencies: CDMO Management, Technology Transfer, Packaging, Labeling, and Distribution of Clinical Trial Supply, GMP Operations, QbD, Regulatory Interactions, Project Team Governance Additional Relevant Experience: I am pursuing my executive MBA to strengthen my skills as a leader including supply chain operations and overall business management.

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