Vince Narbut
Principal Consultant @Biologics Consulting
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WORK HISTORY
Principal Consultant @Biologics Consulting
Broad biopharmaceutical technical expertise and leadership skills to assist clients in the following areas- Design, validation and startup of Manufacturing facilities - Development, implementation and improvement of quality systems including risk management - cGMP audits - facilities and suppliers- CMC planning, technology transfer and CMO oversight (bacterial fermentation, mammalian cell culture, protein purification, aseptic fill/finish operations)- Gap analysis and development of CMC manufacturing and process development sections for regulatory submissions- Due diligence with regard to manufacturing capabilities and quality systems- QbD, process risk assessments, and process validation- Validation master planning and strategy development- IT Quality oversight and Part 11 compliance
EDUCATION
Cornell University
BA, Biochemistry
Babson F.W. Olin Graduate School of Business
MBA
SKILLS
ABOUT VINCE NARBUT
Senior Biopharmaceutical Operations and Quality leader with 30 years experience in cGMP manufacturing and quality assurance. Proven success leading process development, technology transfer, process engineering, facility design/startup and business process improvement initiatives. Provided key leadership, direction, organization, training, management, monitoring and cGMP compliance oversight of manufacturing, engineering and quality assurance personnel. Developed department expense and capital budgets, strategic growth plans, staffing strategies, and facility optimizations. Significant experience in quality assurance, developing and overseeing quality systems, validation, IT and automation compliance. Heavily involved in global CMC regulatory submissions and regulatory inspections.Specialties: Operations/Plant Management, Quality Management, Risk Management, Budget Management, Continuous Improvement,Quality Systems, cGMP, Validation, Six Sigma Champion, Quality by Design, PAT, Design of Experiments (DOE), HAZOP, FMEA, ITIL, GAMP, CFR Part 11, Facility and Equipment design
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