Biologics Consulting Group, Inc.
is pleased to make the following announcement:

Vince Narbut, M.B.A joined Biologics Consulting Group, Inc., as a Senior Consultant (Biopharmaceutical Products) in February 2011.  Vince’s areas of expertise span numerous aspects of biopharmaceutical process development, manufacturing, engineering, IT and quality assurance.

Vince comes to BCG with over 26 years of experience in the biopharmaceutical industry, all at Biogen Idec.  Most recently, he was Director of Quality Technical Systems at Biogen Idec.  In this role, 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).  Vince also oversaw the development of Biogen Idec’s quality system around process and analytical method development (including approaches to QbD, PAT and process trending), an Analytical Technology group supporting global QC and a Quality business planning/project management function.  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 1 comprehensive global program.  

Prior to joining the Quality organization at Biogen Idec, 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 first 15,000 L cell culture facility in RTP, NC as well as a subsequent Purification facility expansion.  Vince then moved on to the engineering design of two Aseptic Fill/Finish facilities and  Biogen Idec’s 2nd 15,000L cell culture facility, all planned for construction in Europe.  As part of this effort Vince worked out of London, UK for a year.  Upon return to the US he worked on several RTP, NC-based global engineering projects including development of a wastewater model and management strategy to avoid construction of a wastewater treatment plant, plant de-bottlenecking and optimization in support of a new 15,000 L scale commercial product, and a warehouse optimization initiative.

Vince spent the first 15 years of his career at Biogen in clinical and commercial product manufacturing culminating in the successful design, validation, startup and operation of the company’s 2,000 L cell culture facility in RTP, NC.  As part of this effort, he interacted frequently with FDA and other regulatory agencies for the review of the company’s facility design as well as for pre-approval and subsequent GMP inspections.   Prior to relocating to NC in 1996 Vince managed the clinical and commercial cell culture and purification manufacturing operations executed at the company’s facility in Cambridge, MA.  This effort culminated with the successful FDA and EMEA inspections of the facility for commercial licensure of Avonex, Biogen Idec’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 B.A. in Biochemistry from Cornell University and a Master of Business Administration from Babson College.

As a Senior Consultant for Biopharmaceutical Products at Biologics Consulting Group, Vince will utilize his broad technical expertise and leadership skills to assist clients in the following areas:

• Design, validation and startup of Manufacturing facilities  
• Optimization and improvement of existing manufacturing facilities and operations
• Development, implementation and improvement of quality systems including risk management 
• Operations Excellence initiatives including business process improvement and implementation/integration of IT-based solutions.
• CMC planning, technology transfer and CMO oversight (bacterial fermentation, mammalian cell culture, protein purification, aseptic fill/finish operations)
• Due diligence with regard to manufacturing capabilities and quality systems
• QbD and process risk assessment
• Validation master planning and strategy development
• IT cGMP compliance oversight and Part 11 compliance

View Mr. Narbut's Curriculum Vitae...

Page Updated May 31, 2011