V2 Bio-Consulting Leadership
C Vorheis, CEO and Principal
- Kay F Vorheis, Finance Director
- 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
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
Jennifer Garbarino, Process
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
Amante, QA, QC and
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
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.
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.