Ben Roberts
Associate Director, Cell & Gene Therapy Drug Product Process Development
- Role
- Associate Director, Cell & Gene Therapy Drug Product Process Development at Novartis
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Ben Roberts
Associate director with 14 years of experience leading teams in Drug Product R&D lab operations, DP/fill-finish (FF) tech transfers and process development initiatives with a strong focus in formulation development and fill finish operations systems for cell and gene therapies, biologics, and small molecule products. Experience includes tech transfers, product development, experimental design, process development, CMO management, and process validation. Experience in supporting BLA and IND approval to both US and ROW markets.
Experience
Associate Director, Cell & Gene Therapy Drug Product Process Development
Oct 2024 — Present
Education
North Carolina State University
Bachelor of Science (B.S.), Chemical Engineering
2005 — 2010
North Carolina State University
Bachelor of Science (B.S.), Applied Mathematics
2005 — 2010
Skills
- Gmp
- V&V
- Process Simulation
- Design of Experiments
- Manufacturing
- Process Engineering
- Minitab
- Data Analysis
- Capa
- Validation
- Quality Assurance
- Pharmaceutical Industry
- Fda
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