Vincent Narbut, MBA joined Biologics Consulting as a Senior Consultant (Biopharmaceutical Products) in February 2011. Vince has over 30 years of experience in the biopharmaceutical industry including technical expertise and management experience in process development, manufacturing, engineering, IT and quality assurance. Since joining Biologics Consulting, his work has included: Establish quality systems and develop simulation models for raw material distributor. Develop cleaning and process validation master plans and perform process risk assessments. cGMP manufacturing facility (DS/DP/Cell Therapy; Client and CMO), quality system, drug depot, raw material/component and computerized system vendor audits. CMC regulatory submission gap analysis, drafting and reviews (32S, 32P, 32A manufacturing and development sections). QbD assessments and review of process validation documents. Cell culture and purification process troubleshooting. Facility design reviews (drug substance, drug product, cell therapy facilities). Quality Engineering oversight for new biopharmaceutical manufacturing facility design, construction, commissioning and validation. Due diligence assessments for products and corporate capabilities. Drug substance and drug product process validation support (including development of procedures for Process Design using QbD, Process Performance Qualification, Continued Process Verification).
Vince worked for over 25 years at Biogen in Cambridge, MA and Research Triangle Park, NC. As Director of Quality Technical Systems at Biogen, Vince was responsible for cGMP oversight of corporate IT systems and automation as well as the strategic direction of the IT platforms used to support the Global Quality organization (LIMS, Training management, Deviation/CAPA/Change control management, Product Complaints and Document management. Prior to this role, Vince served as Director of QA Validation with responsibility for developing and consolidating all facility/equipment, cleaning, automation, computerized system, analytical method, process, and shipping validation approaches used in the company into a comprehensive global program. Prior to joining the Quality organization at Biogen, Vince spent several years in the Global Engineering organization as Manufacturing Technology Principal. He was instrumental in the design and startup of the company’s 15,000 L scale manufacturing facilities in RTP, NC and Hillerod, Denmark. He also worked on the engineering design of two Aseptic Fill/Finish facilities in Europe. Vince spent the first 15 years of his career at Biogen in clinical and commercial product manufacturing, managing the operation of the company’s 2,000 L scale facilities in Cambridge, MA and RTP. These efforts culminated with the successful global regulatory agency inspections of both facilities for commercial licensure of Avonex, the company’s first commercial product.
Vince has made numerous presentations at technical forums including PDA, Interphex, ISPE, CASSS, Waterside Biotechnology Conference and NC Biotechnology Center Investor forum. He holds a BA in Biochemistry from Cornell University and a Master of Business Administration from Babson College.
MBA, Babson College, Babson Park, MA
BA, Biochemistry, Cornell University, Ithaca, NY
Fluent in French