Matthew Johnson
Vice President, Drug Substance at Akero Therapeutics
- Role
- VP Drug Substance at Akero Therapeutics
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Matthew Johnson
An experienced professional that understands and facilitates the CMC development of biologics, vaccines and advanced therapeutics from research to clinical development and on to commercialization- Building robust product development plans- Capital project scoping, design and execution- New technology evaluation and investment- Organizational design and execution- Execution of technical packages to enable INDs, process validation and BLA submission- In depth experience with FDA/EMA/PMDA submissions and inspections
Experience
VP Drug Substance
Oct 2024 — Present
Education
North Carolina State University
MBA, Business Management
Cornell University
BS, Biological Engineering
North Carolina State University
Doctor of Philosophy (PhD), Chemical Engineering
Cornell University
Bachelor of Science - BS, Engineering
Skills
- Biotechnology
- Pharmaceutical Industry
- Biopharmaceuticals
- Gmp
- Technology Transfer
- U.s. Food and Drug Administration (Fda)
- Validation
- Standard Operating Procedure (Sop)
- Manufacturing
- Corrective and Preventive Action (Capa)
- Biotechnology Industry
- Business Process Development
- Pharmaceutical Process Development
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