Ron Demarco

Associate Director - Global MSAT

Role
Associate Director at Gilead Sciences
Location
San Diego County, CA, US
LinkedIn followers
500 followers
Research & DevelopmentView LinkedIn profile

About Ron Demarco

PROFILEMotivated biotechnology professional with 25+ years of experience purifying, analyzing and transferring proteins and processes. Experience ranges from bench scale to 15kL scale with roles of increasing responsibility. Solid record of using extensive biotechnology background to identify and solve complex problems. Recent experience in CMC strategy. Committed to high quality work. SKILLS• CMC Strategy • Technology Transfer • New Product Introduction• Process Validation • Process Characterization • Protein Purification• Chromatography • Column Packing • Protein Analysis• Document Author • Manufacturing Support • Pilot Plant Operations• Process Troubleshooting • Deviation / CAPA • LIMS

Experience

  1. Associate Director

    Gilead Sciences

    Jul 2023 — Present · Oceanside, CA, US

    Lead drug substance technology transfers from project initiation through PPQ and regulatory approval• Partner with Process Development to support process characterization and process definition in support of tech transfers, validation and commercial manufacturing• Author process validation sections of regulatory filings and provide strategy to other CMC sections • Develop staff, direct reports and other team members• Lead technical analysis for external manufacturing site selection• Primary point of contact with contract manufacturing organizations

Education

  • University of Miami

    BS, Biochemistry

    1986 — 1991

Skills

  • Cgmp
  • Biochemistry
  • Microbiology
  • Lifesciences
  • Purification
  • Western Blotting
  • Filtration
  • Lims
  • Life Sciences
  • Gxp
  • Aseptic Processing
  • Elisa
  • Laboratory
  • Biopharmaceuticals
  • Antibodies
  • Downstream Processing
  • Monoclonal Antibodies
  • Assay Development
  • Cell Culture
  • Pharmaceutical Industry
  • Sop
  • Quality System
  • V&V
  • Fda
  • Validation
  • Capa
  • Gmp
  • Trackwise
  • Hplc
  • Cleaning Validation
  • Process Development
  • Chromatography
  • Protein Chemistry
  • Process Validation
  • Sds-Page
  • Immunoassays
  • Corrective and Preventive Action (Capa)
  • Biotechnology
  • Protein Purification
  • 21 Cfr Part 11

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Ron Demarco — Associate Director at Gilead Sciences in San Diego County, CA, US | Unifers