Ronald E. Antes

About Ronald E. Antes

SIGNIFICANT QUALIFICATIONS: • 30+ years of quality experience in GMP…

Experience

1. Director, Quality Assurance, Research and Development

   Sabin Vaccine Institute

   Feb 2023 — Present

   Develop, lead and drive all GXP Quality aspects of Sabin’s projects; accountable for generating, managing and executing QA deliverables on time and in budget • Manage and keep current all Quality policies, SOPs and the overall quality system, ensuring federal and other regulatory compliance • Devise, train and guide the implementation of best practices for Sabin’s quality; ensure compliance with internal and external policies and regulations, as applicable • Ensure appropriate quality issue management processes are established • Manage quality improvement initiatives and risk management principles • Evaluate quality risks of and recommend solutions to product and clinical safety issues during clinical phases • Review data analyses and final study reports • Manage the conduct and reporting of audits of contracted organizations to ensure compliance with domestic and international ethical and regulatory guidelines, as needed • Prepare and sign off on quality agreements with all subcontractors, as needed • Oversee all site QA/QC operations to ensure that assessment of materials, in-process production, shipment, lab activities, running of assays and sample testing is performed consistent with GXP, IND specifications and Sabin standards • Serve as the primary QA/QC interface with regulatory, product, clinical and preclinical development teams, including QC assay development staff • Build strong relationships and manage external QA/QC consultants in the delivery of their scope of work • Supervise/manage direct reports and/or contractors/consultants as needed

Education

• University of Oregon

  BS, Chemistry

  1983 — 1988

Skills

• Regulatory Submissions
• Pharmaceutical Industry
• V&V
• Software Documentation
• Quality Assurance
• U.s. Title 21 Cfr Part 11 Regulation
• Biotechnology
• Technology Transfer
• Uv/Vis
• Analytical Chemistry
• Aseptic Processing
• Good Laboratory Practice (Glp)
• U.s. Food and Drug Administration (Fda)
• Standard Operating Procedure (Sop)
• Vaccines
• Chromatography
• Regulatory Affairs
• Gmp
• Biopharmaceuticals
• Fda
• Computer System Validation
• Pharmaceutics
• Hplc
• Regulatory Requirements
• Change Control
• Quality Control
• Microbiology
• 21 Cfr Part 11
• Validation
• High-Performance Liquid Chromatography (Hplc)
• Verification and Validation (V&V)
• Cleaning Validation
• Quality System
• Capa
• Laboratory Information Management System (Lims)
• Laboratory
• Lims
• Gxp
• Glp
• Corrective and Preventive Action (Capa)