Marlene Garcia Swider, PhD

Adjunct Professor, Department of Biology and Chemistry

Photo of Marlene Garcia Swider, PhD

Biography

Marlene Garcia Swider, PhD, worked at the Food and Drug Administration (FDA) for 32 years as an investigator, reviewer, and scientist for biotechnology drugs. She also was quality manager and public affairs specialist for the FDA working with Congress. After retiring from the FDA, she started her own consulting firm, Biotech Online, as a trainer and consultant for customized regulatory affairs and quality courses for industry. She also enjoys teaching management, leadership, clinical trials, and regulatory affairs at local universities at the undergraduate and graduate levels. Other passions of hers include biking, dancing, cooking, gardening, community service, and coordination of events for the community.

Education

  • PhD, Organizational Management, Capella University
  • MS, Health Service Administration, University of Puerto Rico
  • BS, Biology, University of Puerto Rico

Credentials/Certifications

  • Certified Project Manager (PMI)
  • Six Sigma Black Belt (ASQ)
  • Distinguished Toastmasters, Toastmasters International, 2018

Academic Area

  • College of Liberal Arts and Sciences
    • Department of Biology and Chemistry

Expertise

  • Organizational Management
  • Process Improvement
  • Project Management
  • Quality Assurance
  • Regulatory Process (BLAs, NDAs, INDs, and Clinical Trials)

Courses Taught

  • BIOT 513 – Regulatory Affairs for the Biotechnology Industry
  • BIOT 517 – Clinical Trials