George Robertson
Vaccine development and manufacturing
- Role
- Contractor to Barda and the Us Department of Defense (Jpeo-cbd at GAP Solutions, Inc.
- Location
- Fairfax Station, VA, US
- LinkedIn followers
- 500 followers
About George Robertson
Specialties: International Quality Assurance, GMP complianceVaccine manufacturingVaccine developmentFacility and process validationAnalytical method validationBiodefense and counterproliferation
Experience
Contractor to Barda and the Us Department of Defense (Jpeo-cbd
Sep 2018 — Present · Herndon, VA, US
As the vaccine manufacturing, development and quality subject matter expert as part of the Strategic Drug Portfolio Leadership and Decision Advisory Team of GAP Solutions, Inc. I am providing regulatory risk and regulatory risk mitigation assessments and consultation to the Biomedical Advanced Research and Development Authority (BARDA) COVID-19 response and the Joint Program Executive Office (Chemical Biological Radiological and Nuclear [CBRN] Defense) and the Joint Science and Technology Office of the Defense Threat Reduction Agency. The Team provides expert advice regarding chemical, biological, radiological, and nuclear (CBRN) threat medical countermeasures (MCMs). My scope includes specific emphasis on Chemistry, Manufacturing and Controls (CMC) including Bioprocess & Pharmaceutical Development, Analytical Development; Manufacturing Operations and Quality Assurance/Control activities.
Education
The Wharton School
Certificate, Business
1982 — 1984
University of Pennsylvania
PhD, Molecular Biology
1972 — 1977
Villanova University
Master’s Degree, Biology
1970 — 1971
Valley Forge Military Academy
High School
1962 — 1966
Washington and Lee University
BS, Biology
1966 — 1970
Skills
- Cell Culture
- Lifesciences
- Technology Transfer
- Validation
- Science
- Biodefense
- Gmp
- Pharmaceutics
- Protein Chemistry
- Infectious Diseases
- Capa
- Good Laboratory Practice (Glp)
- Counterproliferation
- Clinical Development
- International Project Management
- Quality Assurance
- Cgmp
- Glp
- Quality System
- V&V
- Molecular Biology
- Process Validation
- Vaccines
- Microbiology
- Drug Development
- Biopharmaceuticals
- Immunology
- Biosecurity
- Life Sciences
- Biotechnology
- Protein Purification
- Virology
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