Conference Advisory Board

Ricardo Acosta

Director, Global Logistics IT Merck

Ricardo Acosta is a recognized Senior Executive and Change Agent with global exposure and outstanding record for driving large scale projects that grow business and create organizational capacity for multinational consumer goods and pharmaceutical companies. He has developed strategies to ensure efficient, transparent and compliant operations where effective information flow enables business unit leaders to make good decisions. He has been the key in influencing new technology acceptance in other units and getting divisions to recognize IT as the foundation that integrates all areas of the organization.

Fernando Gonzalez

Vice President
ISPE Puerto Rico Chapter

Vanessa Alvarado Guevara - PHR

HR Training and Organizational Development Senior Manager
CooperVision

Ricky Gutierrez

President
ISPE Puerto Rico Chapter

Ricardo A. Gutierrez has serviced the industry since 1998. He joined the ISPE Puerto Rico Chapter in August of 2003. Ricky holds a Bachelors Degrees in Business Administration with a major in Marketing from the Inter American University of Puerto Rico. His knowledge and dedication have earned him several awards. Presently he works with Distribuidora Internacional El Dorado, Inc. as a Business Development Manager.

Ricky has been a Chapter Board Member during the past five years as President and Vice President and ran the Financial Administration of the Puerto Rico Chapter as Treasurer. As a team member he has participated in all activities sponsored by the Puerto Rico Chapter.

Victor Batista

General Manager
Pfizer Carolina

General Manager, Over twenty-seven years of experience in Biopharmaceutical Technology, Validation, Manufacturing Operations, and Quality Assurance. Mr. Batista has extensive experience in the pharmaceutical industry, primarily in the International Standards and requirements for Manufacturing, Validation and Quality Assurance. He has held Quality Assurance positions at Schering-Plough, which included responsibility for quality assurance programs, compliance, FDA/Corporate audits and the validation of a new facility. He also has experience in QA compliance at Syntex Laboratories and Biomedical Research at the University of South Alabama. At Raytheon Engineers and Constructors, he was responsible for over 150 consultants worldwide providing validation and GMP compliance support services to the healthcare industry throughout North and Latin America, Europe and Japan. At Lockwood Greene he was responsible for the International Validation and Technical Services Program. He was also responsible for the technical review of GMP compliance issues relating to pharmaceutical design projects. With Wyeth, he directed technology for the facility, processes, systems, and equipment to meet international regulatory compliance and company goals for new and existing products. With Pfizer, was responsible for three functional departments at the site, the Non-penicillin Parenteral Manufacturing Facility, the Supply Chain and Technology. Currently, is the General Manager at the Pfizer Carolina site. Mr. Batista holds a BS in Biology from the University of West Florida, and MBA from Universidad del Este and is a member of the International Society of Pharmaceutical Engineering (ISPE) and the PDA International Association for Pharmaceutical Science and Technology.

Eugenio A. Longo

Executive Director
BioCED Corporation

Eugenio A. Longo, Visiting professor at private Universities as Biomedical Engineer and Executive Director of BioCED, Continuous Education Corporation Eugenio has 24 years of experience in the Life Sciences areas including Bioinstrumentation, Healthcare, Pharmaceutical & Medical Device Equipment Management and Service; Hospitals, Pharmaceutical and Biotechnology facilities renovation & design, and Clinical Research consultant for Universities in Puerto Rico, USA and Latin America, on product and process development.

He serves as a speaker on a wide range of forums in Puerto Rico and Latin America and he has been a Board Member of the International Society of Pharmaceutical Engineering (ISPE) PR Chapter for the past seven years, and at PR Physiological Society for the past two years acting as Student Development Affairs Chairman, Young Professionals advisor and Industry Advisor for Universities.

Eugenio background is Chemical Engineering from University of Puerto Rico, Mayagüez Campus, Physiology from the U.P.R. School of Medicine and Biomedical Engineering from Boston University.

José A. Caraballo

Director of Validation
Amgen

José A. Caraballo is Director of Validations for Amgen, where he directs all aspects of the validation process (e.g. resources, strategy, execution, compliance) for the multi-plant operations site at Juncos, Puerto Rico. He has more than 28 years of experience gained through multiple positions and assignments in the Pharmaceutical and Biotechnology industry, such as Process Engineer, Automation and Controls Section Manager, Process Support Technical Services Manager, Quality Assurance Manager, Fermentation Development Section Head, Director of Biotech Expansions, Quality Director for Fill and Finish Operations, Director Site Quality Assurance, Senior Principal Engineer, and Director Validation.

José holds B.S. and M.E. degrees in Chemical Engineering from the University of Puerto Rico and an MBA from the University of Phoenix. He is a member of the Professional Engineers and Surveyors Association of Puerto Rico (CIAPR), and is registered as a licensed Professional Engineer in Puerto Rico. He currently serves as an elected Member of Board of Directors for the Institute of Chemical Engineers - CIAPR, Editorial Reviewer for ISPE's Pharmaceutical Engineering Magazine, Member of the PDA Letter Editorial Committee (PLEC), and Member of the Advisory Board for INTERPHEX- Puerto Rico Conference 2012.

Ivan Lugo

Executive Director
INDUNIV Research Consortium

Ivan has over 28 years solid Global Executive Leadership, Technical, Entrepreneurial and General Management experience with world class pharmaceutical, biotech and chemical corporations. Initiated his career in 1975 as Production Supervisor at Eli Lilly fermentation plant startup, moving to Monsanto in St. Louis to work as Research Chemist, joining Merck & Co on 1981. With 20 years with Merck and Co. he held several positions in Operations and General Management at a bulk chemical and solid dose plants in New Jersey, West Point, PA, Mexico & PuertoRico. Ivan Lugo is currently Executive Director of the INDUNIV Research Consortium, organization dedicated to the development of the knowledge economy, making Puerto Rico the place for new investments retaining our manufacturing base, through effective interaction between Industry, Academia and Government . Lead the development of the Biotech and Pharma Clusters and the Life Science Roadmap for Puerto Rico and facilitated the Knowledge economy policy development and supporting legislative projects.

As a Life science Industry expert, on 2010 Ivan provided consulting services to the Qinhuangdao Province Economic Development Bureau in China for the development of a Biopharmaceutical Manufacturing and Research Park. He also continues to be a keynote speaker at symposiums and congress around the world.

Ricardo Clinton

Manufacturing Manager
Roche Diagnostics

Francisco Martinez

Office and Business Developer Manager
Fluor

Nestor Contreras

IT Operations Leader
BD – Information Technology

Luis Martinez

IT Manager
Integra Life Science

Rey Cordova

Quality Control Manager, Bulk
Lilly del Caribe, Inc.

Norma Mejia

President
PRTEC

Norma Mejia, President of Beyond Productivity has over 25 years experience in manufacturing operations in the medical devices and electronic fields. She worked as General Manager for different companies (large and small) and consistently was able to improve operations by increasing bottom line results; improving operational performance (quality and services), and improving communications and morale through cultural organizational transformation.

Mejia has a BS in Medical Technology from the University of PR – Mayaguez Campus and has taken several management courses with the London Business School and the American Management Association. She is the President of the Board of PRTEC and is a founder member of the PR Medical Devices Cluster. She also served five (5) years in the PRMA Board as Regional Director 2002 – 2005 and as Secretary from 2005 -2007.

Mejia also collaborates with several nonprofit organizations donating her time; Deborah Hospital Foundation, American Heart Association and the Mayaguez Children Library.

Lourdes De Cárdenas, Ph.D.

Vice-President of Operations, Latin America
Stryker Global Quality and Operations

Holds a B.S. in Chemistry (Magna Cum Laude) from the University of Puerto Rico, Río Piedras and a Ph.D. in Chemistry from Purdue University. Has 26 years of experience in manufacturing, quality and development in the regulated industry, working for 22 years in the pharmaceutical industry and, recently, 4 years in the medical device sector. Has worked for companies such as Bristol-Myers Squibb, Lederle,Astra-Zeneca, Eli Lilly, Patheon and Stryker, in leadership positions in Quality and Regulatory, Technical Services, Pharmaceutical Technology, and Plant Management areas. Also holds a position of Associate Professor in the Graduate Program on Manufacturing Competitiveness at the Polytechnic University of Puerto Rico. Currently holds the position of Vice-President of Operations for Latin America at Stryker Corporation, responsible for 2 manufacturing facilities in Puerto Rico, and for contract manufacturers in Latin America.

Justo O. Moreno

Executive Director, Information Systems
Amgen Manufacturing Ltd

David Diaz

Vice President, Operations
ISO Group

Nelson Perea

Executive Director
PRTEC

Nelson Perea obtuvo un bachillerato en Finanzas y Contabilidad de la Universidad de Puerto Rico Recinto de Mayagüez. Obtuvo una maestría en Finanzas y Negocios Internacionales y una Maestría en Política Pública de la Universidad de Michigan. Termino estudios doctorales en el programa de Democracia, Estado y Derecho de la Universidad del País Vasco en España.

Nelson J. Perea es el Director Ejecutivo del Corredor Tecno económico de Puerto Rico (PRTEC) desde el 2004. Sus funciones incluyen el desarrollo e implementación del plan estratégico de PRTEC así como la administración, relaciones públicas y recaudación de fondos de esta organización. Como parte de sus funciones Perea organiza actividades que promueven la innovación, economía y desarrollo de la economía en Puerto Rico.

Previo a su posición actual, Perea se desempeñó como Presidente y Director Ejecutivo de la Cámara de Comercio del Oeste de Puerto Rico y ocupó diversas posiciones en Finanzas, Inversiones y Gerencia en varias instituciones financieras.

Pertenece a varias organizaciones y es miembro de la junta de algunas de ellas como La Alianza para el Desarrollo de Puerto Rico, la Junta Local del Consorcio Mayagüez-Las Marias, Junta Asesora del SBTDC, Comité Centenario RUM, Movimiento Mayaguezano Pro Desarrollo del Oeste, Comité de Promoción y Educación de Porta del Sol, Junta Asesora de la División de Capital de Riesgo del Banco de Desarrollo Económico de PR, entre otros.

Nelson Flores

Director of Special Events
Puerto Rico Manufacturers Association

Director of Special Events for the Puerto Rico Manufacturers Association. Graduated with a Master Degree (Cum Laude) in Business Administration with concentration in Marketing. More than 25 years experienced providing service to the members of the Association. The last eleven years as the Director of Special Events. Organizing seminars, academies, business meetings, speaker events, business trips and the Annual Convention. In charge of all of the negotiation, promotion, obtaining funds (sponsorship) and the actual celebration of these events.

Juan Perez

President & Principal Consultant
Quality Computer System Validations, Inc.

Mr. Pérez, started his professional career while still in college with the Central Intelligence Agency. He then joined Johnson & Johnson where he worked for over 13 years in diverse IT Projects in Puerto Rico, United States and Brazil. As an expert in IT Compliance, he founded QCSV Inc in 2004 with the goal in mind to help IT and QA communicate with each other and help IT to understand their regulatory responsibility with FDA laws and regulations.

Mr. Pérez is also a speaker and has had appearances at Pharma IT Forum, Interphex and the International Pharmaceutical Academy in Canada. He has published several articles related to IT Compliance in the lifescience industry and is a former member of the Editorial Review Board for Pharma IT Journal publication in United Kingdom.

Manuel Garcia

IT Quality Assurance Director
MMM Holdings, Inc.

Manuel Garcia has over 20 years of experience leading Information Technology organizations and applying expertise in software development, quality, regulatory compliance, continuous improvement, and project management. Repeatedly proving his ability to lead through diverse and challenging situations he has held several positions with increasing responsibilities. Currently is the IT Quality Assurance Director at MMM Holdings, Inc. leading multiples quality and continuous improvement initiatives. Previously served as Global IT Quality Assurance Director for Pall Corporation where he developed the IT Quality Management System and the quality plan for the worldwide ERP (SAP) implementation. Possess a very well balanced skills set of strong technical background and solid management experience from highly regulated industries: Healthcare, Medical Devices, and Refinery. As a creative problem solver, fiscally conscious, and result oriented technology director, Manuel Garcia has applied this combination of practical and academic experience to several of major corporations to drive bottom line improvements and business goals. He holds a Master degree in Information Systems, a Bachelor degree in Computer Sciences, and is an active member of American Society of Quality (ASQ) from which has been Certified Software Quality Engineer since 2006.

Carlos Soto

Plant Manager
NP Caribe

Senior Executive with extensive Operations experience. Carlos graduated Magna Cum Laude from Mechanical Engineering, University of Puerto Rico, Mayaguez Campus; and Summa Cum Laude MBA, Executive Management from University of New Orleans. He was awarded with the Achievement Award as the MBA highest grade student and selected as Student Class Speaker for Masters Graduation. He is the lead Director for Puerto Rico Medical Devices Cluster – Benchmarking Group and past Sub-Director for Supply Chain Group. He has been an associate Director of the Southern Region for the Puerto Rico Manufacturer's Association (until 2010) and member of the Puerto Rico Interphex –Medical Device Show Advisory Board since 2010. Carlos was recognized by the International Who's Who of Professionals in 2010. Carlos was recognized as a 40 under 40 by Caribbean Business Newspaper in 2008. Recognized in 2009 as Manufacturer (Industrial) of the Year by the PRMA and winner of the Excellence in Operations Award by Guidant Corp in 2003. Carlos has directed companies to be recognized by Puerto Rico Products Association for Quality Award in 2007 and 2009 for the introduction of new products.

Carlos Tollinche

Director Scientific Affairs
INDUNIV Research Consortium

Esteban González

Principal Process Improver
CooperVision

Bachelor in Sciences form the University of Puerto Rico (Magna Cum Laude) and a Master in Manufacturing Competitiveness from the Polytechnic University of Puerto Rico (Summa Cum Laude). I have been certified as Master Molder I and Maser Molder II by RJG inc. recognized as an international leader in injection molding training, technology and resources.

My first employment experience began at Harvey Hubbell Caribe as Manufacturing Leader. More recently I was able to join CooperVision, as Process Improver in 2004 where I had the opportunity to develop and move towards the position of Principal Process Improver and Green Belt. My commitment toward my profession has allowed me to lead several projects obtaining excellent results exceeding goals and expectations.

Emilio Colon

Sr. Scientist – Qualification Expert
Janssen Ortho LLC

Bio to come.

Nicole Granda-Alvarez, LEED AP BD+C

Project Architect
CAI – Conscious Architectural Initiatives

Bio to come.