Nelson Lopez
Passion to lead excellence and driving organizational transformation in the Biopharmaceutical industry
- Role
- Sr Director Drug Product Development and Manufacturing at Remegen Biosciences
- Location
- New Haven, CT, US
- LinkedIn followers
- 500 followers
About Nelson Lopez
Manufacturing sciences and technology professional with proven success in biopharmaceutical operations, process development, quality, engineering, technology transfer, operational excellence, and CMC regulatory compliance. Deep technical expertise in startup and commercial processes for biologics. Broad experience in manufacturing process operations and quality to keep operations within compliance. Demonstrated success working with cross-functional teams to improve process efficiency and reduce operational cost.Key areas of expertiseBiopharmaceutical Manufacturing | Technology Transfer | Regulatory Compliance | Investigations | Corrective and Preventive Actions (CAPA)| Change Control | Risk Management | Continuous Process Improvement | Change Control | Operational Excellence | Facility System Management | Regulatory Inspections (FDA, EMA, TGA, Health Canada and other international agencies)| Biological License Application | GMP
Experience
Sr Director Drug Product Development and Manufacturing
Nov 2025 — Present
Education
Universidad de Puerto Rico
BS, Biology
1994
Berklee College of Music
Live sound production, Music Technology
Yale University
Post Doctoral Studies, Proteomics
2003
University of Wisconsin-Madison
Ph.D., Molecular Biology, Bacteriology
2001
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