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V2 Bio-Consulting Leadership Team
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. Will Post, Engineering and Project Management Director More than 26 years experience in project/ commissioning management, maintenance and operations. Effective organization, communication and leadership skills. An efficient and flexible problem solver, inventive and innovative. Self-motivated and conscientious with versatile technical expertise, including: instrumentation / electrical systems; process and mechanical systems; technical report, test / commissioning protocol, specification, bid package and contract generation skills. George MacLeod, Production and Filling Director 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. Patricia Read, QA and Regulatory Director More than 20 years in the cGMP/GLP/GCP quality management field. Lead QA/RA Managers in all cGMP quality and regulatory programs for Contract Research Organization (CRO). Includes clinical manufacturing group (formulation development and testing), biosafety testing, protein analysis, Virology, and Cell Bank manufacturing group (virology, genetic analysis, protein analysis, cell, GMP and GLP), and pharma analysis group (USP testing and small molecule stability) testing for pharmaceutical and biopharmaceutical products. Responsible for GMP/GLP compliance at three corporate sites; Drugs (small molecule) and Biologics (large molecule). All three sites recently inspected with no 483s. FDA IND, NDA CMC, DMF and PAI filing, and surveillance inspection experience; FDA meeting experience. Preclinical, clinical and commercial API, raw material, finished product manufacturing and Quality Control. Facility, utility, process, and method validation and qualification. Work closely with technical experts in testing laboratories to develop best testing strategies for clients. Eric Roswall, IT/Compliance Director With over 20 years experience in the industry, Mr. Roswall combines a QC and IT background to provide a unique industry specific an appropriate approach to IT and compliance in Biotech. He has authored company IT strategy and the IT governance program. Developed plan for assessing IT controls and achieving / sustaining GXP and SOX compliance. Worked with COO to develop company risk management strategy as well as business continuity and disaster recovery plans. Keith Life, Euro-Asia Project Director With over 20 years of international experience in the BioPharma industry, Mr. Life has managed international projects including the build out of facilities and renovations of existing facilities. Mr. Life brings a detailed knowledge of project management and the skills required to build a cohesive project team in an international multi-lingual environment. He has held positions such as VP of Operations and Site Director for a BioPharma company in London, England; Director of Operations for a MedImmune Inc, which produced an FDA approved flu vaccine called FluMist; Managed the build out of a $50M facility in Liverpool, England; Renovated many facilities in USA ($20M), Italy ($30M), and the Netherlands ($15M). Currently, Mr. Life consults for several companies in the USA and Europe including Genentech, Inc. (California, USA) to build a largest of its kind in the world research facility of approximately 160,000 sqft at a cost of $145 M. Mr. Life's abilities to strategically organize, build a cohesive project team, manage multi-lingual projects, and utilize a local work force are demonstrated in his proven track record of successful international projects. Tito Shafique, Project Management Director 21 years of leadership experience in project design, construction, validation and delivery in Pharmaceutical and Biotech industries. Held leadership roles in concept/BOD programming, detailed design, and project delivery including construction management, start-up, commissioning and validation. As a Director of Design & Construction, has completed several significant biotech and pharmaceutical projects. Corporate experience includes managing capital projects including design and construction, managing client account, establishing corporate guidelines for project management and leadership roles in good engineering practices. Steve Drake, Validation Director 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.
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. Jennifer Baldwin, Talent Acquisition & Marketing Director Jennifer Baldwin has 10 + years experience in staffing, recruiting, sales and marketing in industries spanning biotechnology and software to real estate and health insurance. Ms. Baldwin has contributed to and collaborated with companies including Genentech, Bayer, Peoplesoft and Documentum. Her broad spectrum of experience gives her a well rounded approach to addressing V2 Bio-Consulting's staffing, marketing and business development needs. |