Vince Wacher PhD

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: facility design reviews (biopharmaceutical DS, DP and cell therapy), regulatory filing gap analyses and drafting, product due diligence assessments, CMO audits and capabilities assessments, quality system and facility audits, process risk assessments, validation master plans and quality engineering oversight for a new facility design, construction and startup.

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.