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Advisory Board

INTERPHEX would like to thank the 2013 Advisory Board Members; a volunteer panel of industry experts whose combined experience represents the spectrum of pharmaceutical and biopharmaceutical manufacturing. Their valuable insights have played a strong role in determining the event's conference program and direction.

Dr. Dilip Ashtekar Dilip Ashtekar, Ph.D.
Sr. Director Quality Control
Gilead Sciences, Inc.
Albert Manigo-Bey Jr.
Sourcing Manager
Teva Pharmaceutical
Michalle J. Alleman Adkins Michalle J. Alleman Adkins
Manager, Life Science Industry Consulting
Emerson
Sanjay Patel
Sr. Director, Global Materials Management
Shire Pharmaceuticals, Inc.
E. Morrey Atkinson Ph.D.
Vice President, Biologics Process Sciences
Bristol Myers Squibb Company
Richard Poska, R.Ph.D.
Director, Regulatory Affairs
Abbvie
Bowman Cox Bowman Cox
Managing Editor, "The Gold Sheet"
Reed Elsevier
Scott Rudge, Ph.D.
Chief Operating Officer
RMC Pharmaceutical Solutions, Inc.
EJ Brandreth EJ Brandreth
Vice President, Quality & Regulatory Affairs
Althea Technologies, Inc.
Jaspreet Sidhu Jaspreet Sidhu Ph.D.
Vice President, Business Development & Pharmaceutical Microbiology
Molecular Epidemiology
Çetin  Çetinkaya Çetin Çetinkaya
Professor
Clarkson University
Russ F. Somma Ph.D.
President
Somma Tech, LLC
John Gilroy P.E.
Sr. Vice President and Principal
IPS - Integrated Project Services
Robert Timko Robert Timko, RPH, Ph.D.
Director CMC Group, Global Regulatory Affairs
AstraZeneca Pharmaceuticals LP
Michelle M. Gonzalez, P.E.
BioPharm Engineering Consultant
Chad Wachter
Sr. CMC Manager
BTG International
Georgia Keresty, Ph.D. Georgia Keresty, Ph.D.
Chief Quality Officer & VP, Quality & Compliance
Johnson & Johnson Family of Consumer Companies
Christopher Verbicky Christopher Verbicky, PhD, MBA
Director of Business Development and Marketing
Coldstream Laboratories, Inc.
M.J. Kimmel
Principal
MJK Solutions
Michael A. Zupon, Ph.D.
Vice President
Pharmaceutical and Manufacturing Technology
MannKind Corporation
Sandra Lueken Sandra Lueken
Sr. Director Quality Assurance
MedImmune
   

Dilip Ashtekar, Ph.D.

Dr. Dilip Ashtekar

Sr. Director Quality Control, Gilead Sciences, Inc.

Dr. Ashtekar is currently responsible for Quality Control, Microbiology and Quality Control Chemistry at Gilead Sciences, Inc. at San Dimas, CA. He also currently serves on the USP Committee of Experts in Microbiology.

He has 28 years of combined experience in R&D, Quality Assurance, sterility assurance, aseptic manufacturing, risk assessment, and Contamination Control in Biotechnology, Pharmaceutical, and Vaccine industries. He has held several positions with increasing responsibilities at Amgen Inc., Medimmune, Watson-Schein Pharmaceutical, Jensia-Sicor Inc, Advance Tissue Science and Ciba-Geigy. In addition, he has over 20 years of experience in microbial, mycoplasma and viral contamination control. Dr. Ashtekar has a strong background in regulatory compliance and extensive experience in remediation of regulatory compliance actions, such as Consent Decree and Warning Letters.

Dr. Ashtekar has also authored several patents; book chapters on microbiology related topics and is a key member of several PDA Task Forces (TR13 - Environmental Monitoring, Chairman of Mycoplasma Filtration Committee and Rapid Microbiological Methods TR33). He has published in excess of dozen publications in anti-infective area in top national and international journals.

Steve Kuehn

Dr. Dilip Ashtekar

Editor-in-Chief
Pharmaceutical Manufacturing

Bio Coming Soon.

Michalle J. Alleman Adkins

Michalle J. 
 Alleman Adkins

Manager, Life Science Industry Consulting

Michalle Adkins has over 20 years of pharmaceutical industry related experience including 13 years with Merck & Co, Inc. She has been a life sciences consultant with Emerson for 8 years, and was recently appointed as manager of the life sciences industry consulting team. In consulting engagements Michalle uses her varied experiences including project management, planning, manufacturing, automation, and engineering. Michalle has worked with several top pharmaceutical and biotech companies providing consulting services in operational excellence related activities, project justification & definition, system & technology upgrade planning, and front end engineering & design definition. Ms. Adkins has a B.S. in Chemical Engineering and an M.E. in Industrial Engineering both from The Pennsylvania State University and a Lean Six Sigma Master Black Belt Certification from Villanova University. She has been a speaker at conferences and has authored several articles for trade journals including Trimming Technology Transfer with Automated Solutions published in Life Science Leader in November 2011.

Çetin Çetinkaya

Çetin Çetinkaya

Professor, Clarkson University

Professor Cetinkaya's technical background is in acoustics, vibration and thermoelasticity, and nano/micro-scale adhesion. His research projects are in the areas of mechanical property characterization and quality monitoring of drug tablets, motion and adhesion/removal of nano/micro-particles, and specialized sensors and algorithms for non-contact/non-invasive process monitoring, and characteriza-tion/testing/analysis of drug tablets and pharmaceutical materials, transdermal drug delivery. These externally funded projects for the Photo-Acoustics Research (PAR) Laboratory focus on a set of critical applications in pharmaceuticals manufacturing, health care and nanotechnology as well as semiconductor manufacturing and MEMS sensors. These research projects have been funded by various federal, state and industrial sources the National Science Foundation, Intel, SEMATECH, Xerox Corp., Wyeth Pharmaceuticals, Pfizer Inc., Consortium for the Advancement of Manufacturing in Pharmaceuticals (CAMP), Praxair/Electronics, and the US Army. He is an ASME Fellow.

Bowman Cox

Bowman Cox

Managing Editor, "The Gold Sheet", Reed Elsevier

As managing editor of "The Gold Sheet," Bowman is responsible for the editorial direction of the leading publication on pharmaceutical manufacturing quality, published by Elsevier Business Intelligence. Wherever innovation takes the battle for compliance, "The Gold Sheet" will be there, sharing the best thinking from industry and the regulators.

Sandra Lueken

Sandra Lueken

Sr. Director Quality Assurance, MedImmune

With more than 20 years of industry experience, she is responsible for developing, deploying and maintaining the overall quality system within the manufacturing facility. Her role includes managing a diverse group of 200+ individuals responsible for all aspects of Quality Control and Quality Assurance operations supporting the manufacture of liquid and lyophilized vials, syringes, and cartridges for more than 40 clients.

As a Quality/Regulatory professional with expertise in contract manufacturing production, Sandra's experience includes process/product/assay transfer and validation activities, aseptic drug product manufacturing, project management, CAPA, laboratory operations, and leading/managing FDA and international regulatory inspections resulting in numerous PAI approvals and several successful clinical to commercial product launches.

Educated in Biochemistry with a Masters Degree in Business Administration from the Eller School of Business, University of Arizona, Sandra's career path includes positions with HollisterStier Laboratories, Ventana Medical Systems, Inc., Systems Integration Drug Discovery Company, and the Jerry L. Pettis Memorial VAMC.

Sandra is a member of Parenteral Drug Association, Regulatory Affairs Professionals Society, National Association of Professional Women, and is co-Chair of the GMP Leadership Group in the International Consortium for Innovation and Quality in Pharmaceutical Development.

Georgia Keresty, Ph.D.

Georgia Keresty, Ph.D.

Chief Quality Officer & VP, Quality & Compliance, Johnson & Johnson Family of Consumer Companies

Georgia Keresty has worked in the healthcare industry for 29 years and in April, 2011 assumed the role of Chief Quality Officer and VP Quality and Compliance, Regulatory Affairs and Medical Safety for the Johnson & Johnson, Consumer Products Company. She is also a member of the Consumer Group Operating Committee.

Her prior assignments at Johnson & Johnson include Leader, JANSSEN Alzheimer Immunotherapy Research & Development, LLC; Vice President, Pharmaceutical Compliance (R&D QA, Drug Safety, Health Care Compliance) and Global Regulatory Affairs and Compliance Officer for the Pharmaceuticals Group; Vice President of Health Care Compliance for Johnson & Johnson and Vice President of Worldwide Quality and EHS for the Centocor Global Biologics Supply Chain (GBSC). Georgia was a member of the Pharmaceuticals Group Operating Committee for four years.

Prior to Johnson & Johnson, Georgia held the position, of Vice President of Worldwide Quality and Compliance for Bristol-Myers Squibb and Site Director Pharmaceutical Manufacturing and Sr. Staff Development Engineer in Product Development at Novartis.

Georgia was a member of ICH Expert Working Group for ICHQ9 – Quality Rick Management and is a member of the International Society of Pharmaceutical Engineers. In addition, she is a current member of the Board of Trustees of Clarkson University and served 6 years on the Board of Trustees for the NJ Foundation for Aging.

Georgia has a broad educational background and holds a BS in Chemical Engineering, BS in Computer Science, MS in Information Systems, MBA in Operations Management and PhD in Operations Management.

Richard Poska, R.Ph.D.

Director, Regulatory Affairs, Abbvie

As a Regulatory Affairs Director in Abbott's Pharmaceutical Products Group, Rich focuses on strategic CMC initiatives. He earned his B.S. degree in Pharmacy from the University of Illinois College of Pharmacy and has worked with solid dosage forms at both Searle Laboratories and The Upjohn Company before joining Abbott. His 20 years of technical experience includes solid dosage form research, production troubleshooting, process improvement and support, harmonization of excipients and processing, application of statistics for manufacturing controls, Puerto Rico liaison and FDA inspection administrator. He is internationally known for his presentations and publications on the application of microwave drying to pharmaceutical processing. He chaired the SUPAC Equipment Equivalents Steering Committee for the International Society of Pharmaceutical Engineers (ISPE) which won the Vice-President's National Performance Review "Hammer Award" for building a government that works better and costs less. Rich has also chaired PhRMA's Technical Leadership Committee and Drug Product Technical Committee and has represented ISPE and PhRMA on the Drug Product Technical Committee of the Product Quality Research Institute. He is a member of the ISPE Community of Practice CMC Steering Committee and is currently a member of the editorial board for the Journal of GXP and the Journal of Validation Technology.

Morrey Atkinson Ph.D.

Vice President, Biologics Process Sciences, Bristol Myers Squibb Company

Dr. Atkinson holds a B.S. in Biology from Indiana University, and a PhD in Biological Sciences from Stanford University. Upon completion of his PhD, Morrey joined Geron Corporation, where he studied the biochemistry of human telomerase. In 1995, Morrey joined Targeted Genetics Corporation, where he served in various roles, including Vice President of Development, focusing on the development and production of vaccines and gene therapies.

In 2002, Morrey joined Eli Lilly and Company, where he held a variety of management positions in Bioproduct Development and Manufacturing. In 2011, Morrey joined Cook Pharmica, LLC, as Chief Scientific Officer and Vice President of Research and Development, Project Management and Drug Substance Manufacturing.

Morrey joined Bristol-Myers Squibb Company in 2012 as Vice President of Process Sciences, where he has responsibility for Process Development, Analytical Development, and Manufacturing Sciences and Technology for the BMS portfolio of investigational and commercial biologics.

Morrey has numerous publications and patents on Process Development of Biologics, focusing on upstream, downstream, viral safety, analytical, and Quality by Design.

Scott Rudge, Ph.D.

Chief Operating Officer, RMC Pharmaceutical Solutions, Inc.

Dr. Rudge is a founder, COO, Chairman of the Board and Principal Consultant with RMC Pharmaceutical Solutions Inc. RMC Pharmaceutical Solutions is a privately held, internationally recognized expert services consultancy focusing on manufacturing and quality issues in the pharmaceutical, biotechnology, medical device and nutraceutical industries. He also serves as Sr. Vice President of Product Development for Bradmer Pharmaceuticals, a start up biotechnology company developing targeted radiolabeled antibodies for the treatment of glioblastoma multiforme. Prior to forming his expert services business, Dr. Rudge was Vice President of Operations with FeRx Inc., a magnetic drug delivery research and development company. Prior to his seven years with FeRx, Dr. Rudge held positions in Process Development and Process Engineering with Amylin and Synergen, and as a Staff Scientist with the National Institute of Standards and Technology. Dr. Rudge serves as an Adjunct Professor of Chemical Engineering at the University of Colorado, where he teaches courses in bioprocessing and bioseparations, and supervises graduate students. Dr. Rudge received his undergraduate degree at Worcester Polytechnic Institute and his Masters and Doctorate degrees in Chemical Engineering at Purdue University. He is the co-author of a best selling text book on bioseparations and engineering entitled Bioseparation Science and Engineering (Oxford Press), and has sixteen other scholarly publications. Dr. Rudge serves on the editorial advisory board to Contamination Containment and Control magazine.

EJ Brandreth

EJ Brandreth

Vice President, Quality & Regulatory Affairs, Althea Technologies, Inc.

Mr. Brandreth brings over twenty-five years experience in the biotechnology and pharmaceutical industries, and is currently the Vice President, Quality and Regulatory Affairs at Althea Technologies. Prior to Althea he was VP of Quality at Favrille, Inc., a personalized medicine start-up. He led the Process Validation Programs for five CBER/EMEA product launches, including Aldurazyme®, Naglazyme®, Zevalin® and Rituxan®. Previous to Favrille, Mr. Brandreth was Senior Director of Quality at BioMarin Pharmaceuticals for five years, and held management positions at IDEC Pharmaceuticals for over eight years. He is an author of PDA Technical Reports, and is currently Chairman of the PDA Biotech Advisory Board. He was a Director for 10 years and President of ISPE, San Diego Chapter. He is a frequent conference speaker, and is a current member of the Interphex Advisory Board. He holds a BS in Biology, UCSD, and a Masters in Business Administration.

Jaspreet Singh , PhD

Jaspreet Sidhu

Vice President, Business Development & Pharmaceutical Microbiology, Molecular Epidemiology

Vice President, Business Development & Pharmaceutical Microbiology, Molecular Epidemiology, Dec 2004 - present

Principal Scientist/Laboratory Research Director, University of Washington, Seattle, WA, Aug 2001-Dec 2004

Senior Research Scientist, University of Washington, Seattle, WA, 1996-2001

Visiting Scientist, University of Washington, Seattle, WA, 1993-1996

Post-Doctoral Fellow, University of Washington, Seattle WA, 1990-1993

Education, Certifications and Interests
PhD, Biochemistry, 1989, Brunel University and Max-Planck Institute for Biophysical Chemistry, Goettingen, Germany
BS (Honors), Applied Biochemistry, 1985, Brunel, University of West London, UK

Professional Memberships
• PDA

Past Memberships
• ISPE
• RAPS

John Gilroy P.E.

Sr. Vice President and Principal, IPS - Integrated Project Services

Mr. Gilroy brings more than 25 years of diverse EPCM experience providing project management and mechanical services to the petrochemical, semi-conductor, pharmaceutical industries and commercial sector. His experience includes design engineering from concept through implementation, system evaluation/analysis and troubleshooting, cost estimating, budget generation, scheduling and overall project execution.

Leading the Design and Project Delivery group at IPS, Mr. Gilroy and his team have completed more than $1B of in-place, technically-based construction in the United States. He has taken the lead in developing and implementing a "Lean" Project Delivery Process, resulting in reduced waste and real value for clients. He established execution methodologies which offer ways to do things better and more efficiently, ultimately delivering higher quality while controlling costs and maintaining long-term operational dependability.

Russ F. Somma Ph.D.

President, SommaTech, LLC

Dr. Somma has more than 30 years of experience working in the pharmaceutical industry, specifically in the areas of production troubleshooting, dosage form development, manufacturing scale up, technology transfer and project management. He has a particular technical interest in the area of solid dosage forms and the physical pharmacy associated with them. Dr. Somma has utilized his technical and managerial talents within cross- and multi-functional teams, mentoring colleagues and direct reports alike. He has had direct responsibility for senior staff, both domestically and internationally, as well as technical development and life cycle management support for a variety of oral solid dosage, novel formulations and therapeutic groups. Additionally, he has served as an invited investigator trainer and liaison for the FDA on various projects and initiatives, affording a unique perspective within Pharmaceutical Regulatory Affairs.

Timothy P. Howard, CPIP, P.E.

Vice President and Company Officer, Commissioning Agents, Inc.

Mr. Howard is a Vice President and Company Officer at Commissioning Agents, Inc., responsible for the Commissioning and Validation services business unit. His responsibilities include maintenance and implementation of the internal quality system, hiring, training, and professional development of resources, and oversight of all major projects.

Mr. Howard serves as a Director on the ISPE international board of directors. He was a member of the Task Team that developed the ASTM standard E2500 on science and risk base qualification and a contributing author to ISPE Guidance Documents on ASTM E2500 Implementation.

He is a former naval nuclear submarine officer, and was previously licensed as a senior reactor operator on a commercial nuclear power plant. Mr. Howard earned a B.S. degree in Mechanical Engineering from N.C. State University, is a Certified Pharmaceutical Industry Professional (CPIP), and a registered professional engineer.

Robert Timko

Robert Timko

Director CMC Group, Global Regulatory Affairs, AstraZeneca Pharmaceuticals LP

Robert J. Timko RPH, PhD has over 30 years of pharmaceutical industry experience in product development and manufacturing and regulatory affairs. He is presently a Director in the Chemistry, Manufacturing and Controls (CMC) Group of the Global Drug Regulatory Affairs Department, AstraZeneca LP. Dr. Timko has also served as the Team Director, Oncology Therapeutic Area, in the Global Regulatory Affairs Chemistry, Manufacturing and Controls Group.

Prior, Dr. Timko was a Section Manager in the Product and Analytical Development Department where he was responsible for various phases of the drug development process including drug discovery support, physical pharmacy, formulation and process development and scale-up, clinical supply manufacture, and facilities support. Dr. Timko joined ZENECA in 1984 as a Group Leader of Solids Development in the Product Development Section. In 1987, he was promoted to Manager of Solid Dosage Form Development. He became a Section Manager in the Pharmaceutical Development Department of Pharmaceutical Research and Development in 1990. He joined the Marketed Products Group of the Drug Regulatory Affairs Department in 1997.

Dr. Timko earned his Bachelor of Science in Pharmacy in 1974 from Rutgers University where he also earned Master of Science and Doctor of Philosophy Degrees in Pharmaceutical Science in 1977 and 1979, respectively. After graduation, he joined Ortho Pharmaceutical Corporation as a Research Scientist in their Pharmaceutical Process Development Group of Pharmaceutical Development where he was responsible for in-line product support, process development and scale-up, and process validation for a variety of dosage forms. In 1981, Dr. Timko was promoted to Senior Research Scientist, and in 1984, he transferred to the Technical Operations Group of the Advanced Care Products Division where he provided technical support to Product Development and Quality Assurance for consumer pharmaceutical and diagnostic products.

Dr. Timko is an active member of a number of professional organizations including AAPS and ISPE. He is a Registered Pharmacist in New Jersey and Pennsylvania. He holds several formulation patents, and has written journal articles and made presentations in the in the areas of formulation and process development and optimization, and equipment instrumentation.

M.J. Kimmel

Principal, MJK Solutions

Over 30 years experience in the Pharmaceutical Engineering and Facility Operation and Maintenance. Currently Principal with MJK Solutions, an engineering consulting firm to the Pharmaceutical Industry. Prior to this, Jim was Senior Director of Engineering and Maintenance for Cephalon, Inc. in Malvern, PA with global responsibility for the Cephalon's Research Facilities worldwide, and the Corporate Headquarters. Prior to Cephalon, held long term positions with Wyeth Pharmaceuticals and ICI Americas (now Astra Zeneca).

Has served the Delaware Valley Chapter of ISPE as President of the Chapter in 2004 -2005, as Membership Committee Chair, and as a general member of the Board of Directors for several years. Currently serves at the International level as member of the Body of Knowledge Task Team, and Chairman of the Facility of the Year Committee.

Married with three grown children, resides in West Chester, PA with wife Pat.

Chad Wachter

Sr. CMC Manager, BTG International

Chad Wachter is the Senior CMC Manager for BTG International, located in West Conshohocken, PA, working on the development and US commercialization of a treatment for varicose veins. Prior to joining BTG, Chad was the Business Ops Manager for GlaxoSmithKline responsible for the Biopharmaceutical R&D Unit GMP OPs facility located at Upper Merion, Pennsylvania. Chad has over 20 years experience in nearly all dosage forms; with intensive engineering, construction, commissioning and qualification biopharm experience during the last 6 years. He has worked in research and development, industrial operations (commercialization), design, GMP, quality assurance and validation areas. Chad has held positions of increasing responsibility throughout his career with many presentations on the aforementioned topics in trade forums. Chad has a BS and MS in Chemical Engineering with a published thesis on red blood cell deformability in patients with artificial hearts from the University of Pittsburgh, a MBA from Drexel University, and he is a registered Professional Engineer in the State of Pennsylvania.

Albert Manigo-Bey Jr.

Manager, Procurement, Watson Pharmaceuticals

Albert Manigo-Bey is a Senior Strategic Sourcing manager at Watson Pharmaceutical, Inc.

He has worked within Procurement for more than 13 years, procuring process manufacturing and facility equipment, sourcing both engineering and construction services. Also, consistently delivering projects on time and under budget while exceeding his clients' expectations.

Mr. Manigo-Bey is people-oriented influence, balanced arbitration, and excellent negotiation skills has helped him to successfully work with mid to large sized companies in building facilities and equipment procurement.

Michael A. Zupon, Ph.D.

Vice President, Pharmaceutical and Manufacturing Technology, MannKind Corporation

Michael Zupon obtained his PhD in biopharmaceutics and also has a BS in pharmacy and an MBA. He spent 13 years at Schering-Plough Corporation and many additional years working in start-up companies. He joined MannKind Corporation in 2007. He has led research/development teams from discovery through regulatory approval in both the US and Europe. His pharmaceutical development experience encompasses both organic small molecule and biotechnology products, and a diverse array of pharmaceutical dosage forms, e.g., semi-solids, liquids, parenterals, controlled release products, aerosols and dry powder inhalers.

Sanjay Patel

Sr. Director, Global Materials Management, Shire Pharmaceuticals, Inc.

Sanjay Patel is currently the head of Global Materials Management at Shire Pharmaceuticals. In his role, he leads the planning, external manufacturing, and distribution teams of virtual supply in fast growing Specialty Pharmaceuticals. He has twenty years experience in various roles including facilities, manufacturing support, procurement and planning.

Sanjay began his career as an engineer, after gaining a B.S. in Electrical Engineering from the New Jersey Institute of Technology.

Michelle M. Gonzalez, P.E.

BioPharm Engineering Consultant

Ms. Michelle M. González – Engineering Director (Retired), with Amgen Inc. in Thousand Oaks, California, has had extensive experience in industry leadership activities dealing with facilities engineering and process systems design, and management of construction projects. Since relocating to the United States in 1965, she has held technical positions of increasing responsibility in mechanical and process engineering with firms such as Shell Oil, Kaiser Engineers, Bechtel Corporation, Fluor Daniel, and Amgen.

Ms. Gonzalez holds an MS in Architecture from the Pontificia Universidad Javeriana in Bogotá, Colombia. She has been a regular lecturer at the Stanford School of Engineering, and holds professional memberships in the American Institute of Chemical Engineers (AIChE), and the American Society of Mechanical Engineers (ASME) Bioprocessing Equipment (BPE) Standard, where she has served as Chair of the BPE's Subcommittee on Surface Finishes, voting member of the Executive and Main Committees, as well as the Certification, and Dimensions & Tolerances Subcommittees. For the past four years she has also been a member of INTERPHEX's Advisory Board.

Additionally, Ms. González has for 21 years been an active member of the International Society for Pharmaceutical Engineering (ISPE), where she has served as a regular technical speaker, a member of the Membership Development Committee, the Program Committee, and the Body of Knowledge Committee; President of the Greater Los Angeles Chapter (2007-2008), and a participating member on the preparation of the ISPE Good Practice Guide for Commissioning and Qualification of Pharmaceutical Water and Steam Systems, the Biopharmaceutical Manufacturing and Process Development Baseline® Guide, the Good Practice Guide for Process Gases, and the soon to be published revision of the Water & Steam Baseline® Guide. Also, she is the author and editor of ISPE's Glossary of Applied Terminology for the Pharmaceutical Industry.

Ms. González has authored various published technical papers dealing with materials of construction for the biopharmaceutical industry including "single use" products technology; facilities programming, pilot plants, and biotechnology process systems.

Christopher Verbicky, PhD, MBA

Christopher Verbicky

Director of Business Development and Marketing
Coldstream Laboratories, Inc.

Dr. Verbicky is currently Director of Business Development and Marketing at Coldstream Laboratories, Inc. and has nearly15 years of experience in the high pressure contract manufacturing industry. He earned his a PhD in Synthetic Organic Chemistry from the University of New Hampshire and also has a BS in chemistry and an MBA. Prior to joining Coldstream, Verbicky held various leadership positions at AMRI and Johnson Matthey in Business Development, Project Management and Chemical Development. Throughout his career he has contributed to leadership and problems solving in areas spanning business and science.

Dr. Verbicky has written or contributed to numerous publications, patents, and presentations in the areas of Pharmaceutical Development, Organic Synthesis, and Project Management. Verbicky currently serves as editorial reviewer for several scientific publications. He joined Coldstream Laboratories, Inc. in 2010.

Professional Memberships:

  • American Chemical Society
  • American Association of Pharmaceutical Scientists
  • Project Management Institute

Christopher Amstutz

Christopher Amstutz

Director Life Sciences Industry Consulting
Emerson Process Management

As Director of the Life Sciences Industry Consulting Group at Emerson Process Management it's more than a job it's a passion. At Emerson Chris's team helps their customers-customers lead better lives by providing solutions and expertise to improve time to market and product quality. They believe in excellence in everything they do and believe that they do make a difference.

Chris has been with Emerson Process Management for 12 years where he has held roles of increasing responsibility. Currently, as the Director of the Life Sciences Industry Consulting Chris coordinates Operational Excellence studies, financial justification studies, general industry consulting, and situational fluency training programs in support of customers' needs worldwide. In addition, he is involved with Emerson's Life Science industry strategy, growth initiatives, and market penetration across all world areas.

Chris's roots are in Operations Management and Manufacturing Execution Systems benefits analysis and business process reengineering. He previously held the role of Director of Software Quality Assurance and Technical support for the Syncade product line.

He is a member of ISPE and voting member of the ASTM E55 committee on Pharmaceutical Manufacturing. Over the past year he has presented at Emerson Exchange, IFPAC, and Interphex and is heavily active in social media @ChristopAmstutz and an active contributor to the Emerson Process Experts blog.

He received his BS Chemistry from Florida State University and an MBA from Florida International University.

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