MCPHS University and Pfizer - Massachusetts College of Pharmacy

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MCPHS University
and Pfizer
Biopharmaceutical Industry
Fellowship Program
Pfizer Worldwide Research and Development
Pfizer strives to improve health and well-being at every stage of life and to set the standard for quality, safety and value in
the discovery, development and manufacturing of medicines for people and animals. Pfizer’s diversified global healthcare
portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products
and many of the world’s best-known consumer products. Pfizer’s primary areas of focus include immunology and
inflammation, oncology, cardiovascular and metabolic diseases, neuroscience and pain, and vaccines.
Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments
and cures that challenge the most feared diseases of our time. Consistent with responsibility as the world’s leading
biopharmaceutical company, Pfizer also collaborates with healthcare providers, governments and local communities to
support and expand access to reliable, affordable healthcare around the world. For more than 150 years, Pfizer has worked
to make a difference for all who rely on them.
Pfizer Biopharmaceutical Industry Fellowship Programs
Pfizer Worldwide Research and Development in conjunction with Massachusetts College of Pharmacy and Health Sciences
(MCPHS University), offers three unique post-PharmD fellowship programs in the following departments:
•Global Clinical Supply
•Pharmaceutical Sciences Quality Assurance
Each two year fellowship program will provide a comprehensive post-doctoral experience that fosters professional
growth and develops skills necessary for a successful career in the biopharmaceutical industry. The fellow will not only
receive training in the specialty area of the fellowship, but will also gain experience in other disciplines within the drug
development process. A certificate will be awarded by MCPHS University and Pfizer Worldwide Research and Development
upon successful completion of the fellowship.
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Global Clinical Supply (GCS)
Our Vision: Global excellence in the quality and delivery of medicines to patients.
Our Mission: Provide quality medicines and services in a compliant, timely, innovative and cost effective manner. We
continuously improve our systems, processes and capabilities in collaboration with our internal and external partners in
support of drug development. Our global team will achieve excellence by focusing on patients, working with integrity and
professionalism in an enriching work environment.
GCS is a global organization that sets the clinical supply strategy, systems, packaging, labeling, logistics and management of
quality investigational products to patients in compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice
(GCP) standards for Pfizer investigational studies. There are two fellowship programs offered within the GCS organization:
• Clinical Supply Chain Strategy and Management
• Clinical Research Pharmacy
Each program is two years in length and designed to enhance the fellow’s understanding of the drug development process
from molecule inception to commercialization. In addition, the fellow will gain insights to the intricacies of the design,
planning, and execution of clinical supplies throughout all phases of development. See below for the unique descriptions
of each fellowship program.
Clinical Supply Chain Strategy and
Management
GCS Program Design
This two year fellowship focuses on application of clinical
supply strategies to effectively manage pharmaceuticals,
biologics, and vaccine-based investigational products in
global clinical trials from study start up to completion.
The fellow will be expected to apply the knowledge and
experience gained within the first year to successfully
manage clinical supplies during the second year.
Clinical Research Pharmacy
This two year fellowship focuses on the development
and implementation of patient focused tools to optimize
the use of investigational products, with an emphasis on
patient adherence. The fellow will be expected to apply
the knowledge gained in the first year to design strategies
for monitoring, evaluating, and improving patient
adherence in clinical trials.
During the first year, both fellows will rotate through
various departments within Research and Development to
gain an understanding of the drug development process
from molecule inception to commercialization. Fellows will
gain core competency in the following areas:
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linical Supply Strategy and Management
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Packaging and Labeling
Global Distribution
Clinical Research Pharmacy
Quality Assurance
Regulatory Affairs
Clinical Development
Phase I Clinical Research Unit
Clinical Supply Systems and Support
Clinical Supply Formulation and Drug Product Design
In the second year, the fellows will be assigned a clinical
project within the scope of their fellowship focus.
GCS Core Objectives
• B
ecome an integral member of Pfizer Global Clinical Supply including working closely with other Pharmaceutical Sciences
Departments, Clinical and Development Operations, Strategic Partners and Quality Assurance
• Gain in-depth experience across multiple facets of the drug development process for pharmaceuticals, biologics and
vaccines from discovery to commercialization
• Enhance project management, communication and leadership skills
• Gain hands-on experience in the manufacture of active pharmaceutical ingredient and drug products as well as the
packaging, labeling and distribution of investigational products
• Develop, coordinate and deliver various Disease State Overviews/Clinical Patient Journeys to multidisciplinary Pfizer
team members
• Engage in studies conducted at the Pfizer Clinical Research Unit (New Haven, CT)
• Learn about the importance of investigational products in the successful execution of a clinical program
• Design, develop, manage and close out phase I–IV clinical trials
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Pharmaceutical Sciences Quality Assurance (PSQA)
Our Mission: To be a proactive partner, driving a science & risk-based compliant quality culture that is flexible, innovative
and customer oriented, maximizing the contributions of Quality Operations.
Phamaceutical Sciences Quality Assurance (PSQA) provides the quality oversight of Pfizer investigational products to
maintain clinical trial integrity, ensure regulatory compliance, and protect patient safety. The PSQA organization monitors
Good Manufacturing Practice (GMP) and works at the GMP/Good Clinical Practice (GCP) interface to provide quality support
for products moving from clinical to commercial manufacture.
The two-year fellowship in PSQA focuses on the quality oversight of operations to ensure compliance with global
regulatory standards and requirements. The approach will use a unique combination of learning the operational activities
as a baseline and moving directly to a supporting Quality Assurance role for the relevant operational function. Fellows will
be able to provide GMP quality support for clinical trial materials (small molecules, biological, and vaccines) by learning
and participating in the GMP Quality Management System within various groups responsible for supporting early phase
clinical studies in humans through post-approval surveillance.
PSQA Program Design
The first year of the fellowship will be focused on gaining
exposure to various divisions within Pfizer, including
Research and Development, Global Supply, and Medical
in addition to Quality Assurance groups. Although the
fellow will be based at the Pfizer Groton, CT site, rotations
may also occur at the Andover, MA and Sandwich, United
Kingdom locations. The fellow will gain quality core
competencies in the following areas:
• Development and manufacture of small and large
molecules for use in clinical trials
• Packaging, labeling and distribution of
investigational products
• Interactive Response Technology (IRT) use for clinical
supply management
• Responsibility of the Qualified Person in European
Union quality oversight
• Extemporaneous compounding
• Audits, inspections and vendor management
• Validation of equipment, facilities, utilities and
computerized systems
• Product complaints and investigations
• Overview of Quality Management Systems
In the second year, the fellow will conduct a project or
fulfill a role of significant value to improving the overall
quality of investigational products. At the end of the
fellowship program, the fellow will have established a
broad understanding of quality oversight and processes
across the product development lifecycle.
PSQA Core Objectives
• Discover the role, responsibilities and
organizational structure of the Pfizer Quality
Organization
• Develop an understanding of the Pfizer Quality
Culture
• Participate in the execution of processes
designed to manufacture, package, label and
distribute investigational products
• Gain knowledge of the role of pharmaceutical
vendors and how quality is assured
• Become familiar with PSQA support systems
such as standard operating procedures, training,
validation, metrics, computerized systems and
auditing
• Understand how to define a strategic quality
direction for technology, innovation and new
business strategies for Pharmaceutical Sciences
• Collaborate with members of the Clinical and
Medical Quality organizations to ensure delivery
of investigational product to clinical sites or
review of extemporaneous dosing records and
dosage and administration instructions
Note: Recruitment for the fellowship program in Quality
Assurance occurs biennially every odd-numbered year.
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Pfizer Fellowship Administration
Fellowship Director: Michael T. Ku, PharmD, MBA
Dr. Ku is Vice President and Global Head of the Global Clinical Supply
organization for Pfizer Worldwide Research and Development located
in Groton, CT. Dr. Ku has over 20 years of pharmaceutical and biotech
experience, with 16 years in the area of Clinical Research/Clinical Supplies.
Prior to joining Pfizer, he was at Genzyme Corporation in Massachusetts.
Dr. Ku has a Master’s Degree in Business Administration from Anna Maria
College, a Doctor of Pharmacy and a Bachelor of Science in Pharmacy from
MCPHS University. Dr. Ku also holds a Bachelor of Science in Toxicology
from the University of Toronto.
GCS Program Leader: Fae Wooding, PharmD, RPh
Dr. Wooding is the Senior Manager of Clinical Research Pharmacy within the
Global Clinical Supply organization at Pfizer Inc. in Andover, MA.
Dr. Wooding has been with Pfizer for over two years and has over 10 years of
combined pharmacy experience in academia, hospital, and ambulatory care.
Prior to joining Pfizer, she was an Assistant Professor of Pharmacy Practice at
MCPHS University. Dr. Wooding has a Bachelor of Science in Human Physiology
from Boston University and completed a specialty pharmacy residency in
Primary Care at the Providence Veterans Affairs Medical Center after receiving
her PharmD from MCPHS University.
PSQA Program Leader: Nancy Borgeson
Ms. Borgeson is a Director in the Quality Assurance Operations Support
Group based at Pfizer, Inc. in Groton, CT responsible for supporting
global operational groups involved in clinical supply packaging, labeling,
distribution and IRT system use. She has over 15 years of experience
in the pharmaceutical industry in both the Commercial and Clinical
GMP manufacturing operational areas as well as Clinical Supply Quality
Assurance. Her experience spans roles that include vaccines, parenteral
manufacturing, packaging, lyophilization, inventory management,
distribution, validation and quality assurance. Prior to her roles in the
pharmaceutical industry she held roles in patient care both in the private
Physician and Hospital settings. She holds a Bachelor degree in Biology and
Business from Oakland University in Rochester Hills, Michigan.
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PSQA Fellowship Coordinator
PSQA Program Coordinator: Matthew Opalenik
Mr. Opalenik is a Senior Manager in the Quality Assurance Group based
at the Pfizer Groton site. He has over 25 years of experience in the
pharmaceutical industry in R&D, commercial, contract manufacturing
and consulting areas. His experience spans QA and IT support with an
emphasis on computerized systems and validation. He holds a Bachelors of
Science degree in Physics from the University of Akron in Akron, Ohio.
Current Fellows
2nd Year GCS Fellow: John E. O’Brien, PharmD
Dr. O’Brien received his PharmD from the University of Rhode Island,
College of Pharmacy in 2013 and is currently completing the second
year of the GCS Fellowship. In addition to completing his core pharmacy
practice requirements, he completed elective rotations in nuclear
pharmacy and academia.
2nd Year GCS Fellow: Luz Shepherd, PharmD, PhD
Dr. Shepherd received her PharmD from MCPHS University in 2013 and
is currently completing the second year of the GCS Fellowship. Prior to
receiving her PharmD, she received a PhD in neurophysiology from the
University of Puerto Rico.
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Current Fellows (Continued)
1st Year GCS Fellow: Adam Craig, PharmD
Dr. Craig is originally from Plainfield, IN and received his PharmD from
Purdue University in 2014. Dr. Craig is currently completing the first year
of the GCS Fellowship, and prior to the fellowships he completed rotations
in Academia, Industry, and traveled to Kenya, Africa for a two month
inpatient elective.
1st Year PSQA Fellow: Jacob Mattox, PharmD, BA
Dr. Mattox received both his PharmD and Bachelor of Arts in Spanish from
Purdue University in 2014 and is the first pharmaceutical fellow in the
PSQA Fellowship Program. In 2014, Dr. Mattox completed stewardship
rotations in Managed Care, Drug Information, and Pharmacovigilance.
He is a recipient of the 2014 Purdue University Patient Care Award for his
efforts during his experiential year. Dr Mattox also serves on the Purdue
Alumni Board of Directors as the Class of 2014 representative.
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MCPHS University
MCPHS University provides an academic environment to guide and support the fellows toward a successful career in the
biopharmaceutical industry. As a private institution with a history of specialization in health sciences, MCPHS University
offers programs that embody scholarship, professional service and community outreach.
Through MCPHS University, the fellow will have the opportunity to gain teaching and research experience in an academic
setting. MCPHS University faculty and company program leaders mentor fellows according to their scholarly and
professional interests throughout the two-year program.
As an adjunct assistant professor at MCPHS University, the fellow will have the opportunity to:
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Develop, coordinate and teach courses at the Boston, Worcester or Manchester campus
Co-precept students on advanced experiential rotations
Create and publish scholarly research and/or review articles
Present research at scientific and clinical meetings
Participate in professional development seminars with other fellows and residents from MCPHS University
affiliated programs
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MCPHS University Fellowship Administration
Director of Fellowship Program: Bernard R. Tyrrell, RPh, MBA
Mr. Tyrrell is the Director of the MCPHS University Biopharmaceutical
Industry Fellowship Program. He serves as Assistant Dean of BA Programs
and Non-Thesis Graduate Programs as well as Associate Professor of Social
and Administrative Sciences at the University. Prior to joining the University,
he spent over 30 years in the industry working for companies like Eli Lilly,
AstraZeneca and Johnson and Johnson. Mr. Tyrrell earned a BS in Pharmacy
from the Massachusetts College of Pharmacy and holds an MBA in
Marketing Management from Bryant University in Smithfield, Rhode Island.
Program Coordinator: Abir Kanaan, PharmD
Dr. Kanaan is an Associate Professor of Pharmacy Practice at MCPHS
University. She joined the University in 2005 after completing a postgraduate pharmacy practice residency at UMass Memorial Medical Center.
Dr. Kanaan holds an adjunct faculty appointment in the Department of
Medicine at the University of Massachusetts Medical School and is also
affiliated with the Meyers Primary Care Institute where she is involved in
several research projects pertaining to medication safety in the outpatient
setting with specific focus on the elderly. Dr. Kanaan also serves as a codirector for the Pharmacy Medication Safety, Quality, and Informatics
Fellowship program at Saint Vincent Hospital in Worcester, MA.
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MCPHS University Faculty Preceptors
Faculty Preceptor: Katherine Carey, PharmD
Dr. Carey earned her Bachelor of Science in Biology from the University
of Massachusetts in 2004 and her Doctor of Pharmacy from Midwestern
University College of Pharmacy-Glendale in 2008. She completed a
postgraduate year one (PGY-1) pharmacy practice residency at Baystate
Medical Center in Springfield, Massachusetts in 2009 and a PGY-2 specialty
residency in Cardiology Pharmacy Practice at UMass Memorial Medical
Center in Worcester, Massachusetts in 2010. Dr. Carey is currently an
Assistant Professor of Pharmacy Practice at MCPHS University, with a
practice in ambulatory care at Baystate Medical Center in Springfield,
MA. Dr. Carey is a Board Certified Pharmacotherapy Specialist. Her areas
of interest include cardiology, diabetes, and researching the impact that
pharmacy students and residents have on patient outcomes.
Faculty Preceptor: Cheryl Durand, PharmD
Dr. Durand graduated from Northeastern University in 2002. Since
graduation Cheryl has been a hospital clinical pharmacist. Currently she
works full time at MCPHS University as an associate professor of pharmacy
practice with a focus in infectious disease and pharmacy advocacy and
leadership. At MCPHS she is a preceptor for Institutional APPE students. At
Elliot Hospital, she precepts residents in the longitudinal teaching elective
rotation. Additionally, she works for Elliot Hospital as a per diem pharmacist.
She currently serves on the New Hampshire (NH) Board of Pharmacy
Continuing Education Advisory Council and is currently the Vice President
of the organization. Cheryl is also a recipient of the Trustees Award for
Teaching Excellence at MCPHS University.
Faculty Preceptor: Paul Belliveau, PharmD
Dr. Belliveau earned his Bachelor of Science in Pharmacy from the
University of Rhode Island in 1988 and his Doctor of Pharmacy
from MCPHS University-Boston in 1991. He completed an Antibiotic
Management Fellowship at Hartford Hospital in Hartford, Connecticut in
1993. Dr. Belliveau is currently Professor and Chair of Pharmacy Practice
at MCPHS School of Pharmacy – Worcester/Manchester. Dr. Belliveau’s
areas of interest include infectious diseases, pharmacokinetics, academic
leadership, and pharmacy education.
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The Application Process
Compensation and Benefits
The fellowship provides a competitive stipend and benefits package, including vacation and comprehensive health
insurance. In addition, the fellowship offers an allowance for professional development which includes travel to
conferences in pharmacy and other specialty areas. The fellow may qualify for student loan deferment, allowing
for the postponement of loan payments until the completion of the fellowship program. The lender of the student
loan(s) will be able to provide specific information regarding eligibility and terms of deferment.
Eligibility
The fellow will be selected through an intensive interview and application process. Applicants must have a Doctor
of Pharmacy degree from an ACPE-accredited college of pharmacy. Candidates must have strong written and
verbal communication skills and an interest in pursuing a career within the biopharmaceutical industry. Applicants
must be a US citizen or have permanent US resident status.
Application
Interested individuals must submit the following documents:
• Curriculum vitae
• Letter of interest
• Three (3) letters of recommendation, each with a Recommendation Request Form
• Official college transcript
Completed applications are accepted from November 1st to January 1st. Early submission is highly encouraged
due to the competitive nature of the fellow selection process. Electronic copies of the application materials
may be submitted; however, a hard copy of the official transcript is required. In addition, electronic letters of
recommendation must be sent directly from the recommender’s work e-mail.
All correspondence should be sent to:
Michael Ku, PharmD, MBA
Vice President, Global Clinical Supply
Pfizer Inc.
Eastern Point Road MS 8220-2255
Groton, CT 06340
E-mail: PharmDFellowships@pfizer.com
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Fellowship At-A-Glance
Location :
Groton, Connecticut
Fellowship Programs :
Clinical Supply Chain Strategy and Management
Clinical Research Pharmacy
Quality Assurance
Length :
Two years
Requirements :
Doctor of Pharmacy degree from an
ACPE-accredited college of pharmacy
and a US citizen/permanent resident
Application Deadline : January 1st
Contact :PharmDFellowships@Pfizer.com
2014 MCPHS University/Pfizer Fellows
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For more information about the fellowship programs, please scan the QR code above.
Pfizer, Groton, CT
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