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

  1. Sr Director Drug Product Development and Manufacturing

    Remegen Biosciences

    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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Nelson Lopez — Sr Director Drug Product Development and Manufacturing at Remegen Biosciences in New Haven, CT, US | Unifers