Ryan Burnett
Director and Platform Lead for Gene Therapy Product, Process, and Analytical Development
- Role
- Director, Gene Therapy Development at Neurocrine Biosciences
- Location
- San Diego, CA, US
- LinkedIn followers
- 500 followers
About Ryan Burnett
As the Director of Gene Therapy Development at Neurocrine Biosciences, I lead the CMC Product and Analytical Development for our gene therapy programs, which aim to treat neurological and endocrine disorders. I have a Ph.D. in Biochemistry and over 20 years of experience in Development, Pre-clinical, CMC, Quality, and Program Leadership for both biologic and solid oral platforms. I manage a team of scientific and engineering staff, oversee the CMO and CRO development planning and partnerships, and plan and execute cross-functional studies for platform development. I also write relevant sections and modules of IND and BLA, and manage a $10M+ annual budget. I have a proven record of delivering successful results in assay and technology development, tech transfer, and process validation. I am passionate about advancing innovative and life-changing therapies for patients with unmet medical needs.
Experience
Director, Gene Therapy Development
Jan 2020 — Present · San Diego, CA, US
CMC Product and Analytical Development Lead for our gene therapy programs • Head the CMO and CRO Development planning and partnerships for manufacturing and testing • Supervise and guide scientific and engineering staff in a variety of analytical, instrumental and biologic methods of analysis, experimental design, and analysis of data • Manage $10M+ annual budget, negotiate contracts, vendor selection and qualification for process and analytical activities • Plan and execute cross functional studies for platform development including process and product characterization, process comparability studies, and PPQ strategy • Write relevant sections and modules of IND and BLA • Plan and manage contracted stability studies for drug substance/product • Perform detailed review of data generated from contracted services providers • Investigate out of specification and out of trend results • Review proposals, contracts, MSAs, Quality Agreements, and invoices for manufacturing and analytical activities
Education
Georgia Institute of Technology
Ph.D., Biochemistry
Indiana University Bloomington
B.S., Biochemistry
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