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V2 Bio-Consulting Leadership Team


  • Kurt C Vorheis, CEO and Principal
  • Kay F Vorheis, Finance Director
  • George MacLeod, Production and Filling
  • Jennifer Garbarino - Process Engineering Director
  • Renel Amante, QA, QC and Regulatory
  • Steven Drake, QA - QE Validation and Regulatory
  • Greg Flood, Business Operations and Project Mangement

 

Kurt C Vorheis, CEO and Principal           

Mr. Vorheis brings over 25 years Bio-Pharmaceutical industry experience to his position with V2 Bio-Consulting, including VP of Manufacturing at Aviron and Sr. Director of Planning and Director of Engineering at Chiron.  His background includes extensive operational and project management experience moving products and facilities from early clinical processes into large-scale commercial manufacturing, and global experience including strategic planning and evaluation of worldwide manufacturing capacity and cost of goods.                         

 

Kay F Vorheis, Finance Director

Ms. Vorheis has over 25 years experience with privately-held and publicly-traded businesses in software and services industries as both Controller and CFO.  The foundation of her career included working four years as a practicing certified public accountant with KPMG Peat Marwick.  Her depth of practical experience has proven key to guiding the finance, accounting and managerial operations of V2 Bio-Consulting throughout its growth.

 

George MacLeod, Production and Filling

With 25+ years experience in the Biotech industry, Mr. MacLeod brings an expert understanding of manufacturing and engineering in new product introductions, project management, design and construction of facilities, quality assurance and validation, supplier sourcing and logistics, contract manufacturing and sterile operations.  At a Director level, he has made solid contributions to companies like Abgenix, Anika Therapeutics, Genentech and others.


Jennifer Garbarino, Process Engineering Director

Over 16 years experience of process engineering within the biotech industry.  Expertise in GMP process and facility design, project management and start-up and commissioning supporting clinical and commercial manufacturing operations.  Proficiently manage multiple assignments while maintaining the highest emphasis on quality.  Areas of expertise include Engineering Design and Project Management, Equipment Procurement, Installation and Commissioning.  Extensive experience in development of GMP documentation for manufacturing and validation including SOPs, BPRs, commissioning plans, and installation/operational qualification and turnover documentation.

 

 

Renel Amante, QA, QC and Regulatory

Mr. Amante is a biotechnology and pharmaceutical professional with over 25 years’ experience.  He joined V2 Bioconsulting from Solstice Neurosciences, where he was Director of Quality Assurance.  There he led Quality Assurance for commercial production of Myobloc, a product distributed in US, EU, Japan, and Korea.  Previously, he was at Acologix Incorporated and led Quality efforts for the US development of a kappa opioid receptor agonist working with business partners from EU and Japan.  Prior to Acologix, Renel held positions of increasing responsibility at various companies developing biologics and small molecules in parenteral and oral dosage forms and has experience with both in-house manufacturing and contract manufacturing.

 

Steven Drake, QA- QE Validation and Regulatory

Over 20 years in QC, QA and validation experience consisting of managing projects for start-up to mid-size drug and device operations. Manage operations to ensure appropriate regulations, standards, and guidelines (e.g. GLP, GMP, GCLP, ICH, USP) are met during facility, equipment, systems and method validation while streamlining validation processes to allow rapid implementation of defensible processes and methods.

 

Greg Flood, Business Operations and Project Management

Mr. Flood is a business, program management, and performance reporting expert. He has worked across a multitude of industries allowing a unique perspective on business. Most recently he has been immersed in the bio-technology and pharmaceuticals industry, but has worked with utilities, medical device manufacturing, NATO Military, US Government and retail industries. His primary focus is on business solutions, contractual accountability, and client reporting. As a leader at V2 Bio he is a point of contact for business consulting, contract management, business development, and recruiting.