Barbara Manfredi

PhD-trained Biomedical Scientist with 10+ years of international experience spanning preclinical drug discovery, translational research, laboratory operations, scientific documentation, and regulatory compliance within academic and regulated research environments in the United States and Europe. Extensive experience supporting GLP-, GCP-, IRB-, and IACUC-compliant activities, developing SOPs, preparing technical documentation, managing controlled records, and ensuring data integrity and inspection readiness. Recently completed GMP training focused on CAPA management, deviation handling, risk assessment, and quality systems.

Demonstrated expertise in scientific writing through peer-reviewed publications, grant applications, patent-support activities, technical reports, and presentations at international scientific conferences. Open to opportunities in Regulatory Affairs, Regulatory Operations, Clinical Research, Medical Writing, Scientific Affairs, Quality and Compliance, and related life science functions within the pharmaceutical, biotechnology, and life sciences sectors.

Postdoctoral Fellow and Laboratory Manager / Operations and Compliance Lead at Oakland University (2022-01 – 2024-12)

Led multiple translational and preclinical drug discovery projects focused on thrombosis, platelet biology, and therapeutic target discovery while coordinating regulated laboratory operations and compliance activities.

• Managed GLP-aligned preclinical research programs supporting 5+ therapeutic discovery projects.
• Developed and maintained SOPs, IACUC protocols, laboratory records, study documentation, amendments, and supporting regulatory documentation.
• Maintained inspection-ready documentation and electronic records supporting internal reviews and compliance monitoring activities.
• Reduced compliance findings through documentation controls and SOP adherence monitoring, and colony management processes, resulting in reduced audit observations.
• Supported research involving human biological samples under IRB-approved protocols.
• Managed laboratory operations including inventory systems, training records, electronic documentation platforms, budget monitoring, and resource planning.
• Trained and supervised 12+ researchers on SOP compliance, documentation standards, and data integrity procedures.
• Identified four small-molecule inhibitors and supported two patent applications.
• Collaborated with multidisciplinary teams, authored 10+ scientific publications, abstracts, technical reports, and conference communications.

Graduate Research Assistant (PhD) at Pennsylvania State University (2018-01 – 2022-12)

• Led preclinical research programs evaluating small-molecule therapeutics.
• Maintained compliant records and prepared technical reports.
• Participated in clinical projects involving data under HIPAA requirements.
• National finalist for two competitive grants submitted to the PhRMA Foundation.
• Presented research at national and international scientific meetings.
• Maintained continuity of essential laboratory operations during the COVID-19 pandemic under enhanced safety and compliance requirements.

Graduate Research Assistant / Teaching Assistant at University of Puerto Rico (2015-01 – 2017-12)

• Coordinated multidisciplinary collaborations and research documentation.
• Assisted in preparation of research proposals and technical reports.
• Organized NIH-sponsored CRISPR-Cas9 workshop.

Research Intern at Centre for Molecular and Translational Oncology (2013-01 – 2015-12)

• Supported translational oncology and diagnostic research projects.
• Participated in validation of an innovative biomedical device for coagulation screening.

Postdoctoral Fellowship – Oakland University (2022-01 – 2024-12)

PhD in Biomedical Sciences – Pennsylvania State University (2022-12)

PhD Studies in Biology – University of Puerto Rico (2015-01 – 2017-12)

MSc in Biomedical Sciences – University of Parma (2013-12)

BSc in Biology – University of Parma (2009-12)