PHARMA BULLETIN
Newsletter of the ISPE New Jersey Chapter Volunme 18, N3
Third Quarter, 2011
Letter from the Editors
It is a pleasure to welcome you to the third quarter 2011 issue of the Pharma Bulletin, the newsletter of the
New Jersey chapter of ISPE. It is an honor for us to be asked to take on the editorial responsibilities for
this publication in this, the 25th Anniversary Year of the New Jersey Chapter. Our Chapter was the first
to be formed within ISPE and our next Pharma Bulletin, scheduled for release at the end of 2011, will
focus on this important and noteworthy anniversary celebration.
This late summer and early fall have proven very active for our Chapter from a number of perspectives,
as the new Board and Committees have been very busy organizing, planning and beginning to execute the
plans for the 2011-2012 year. Please join us in congratulating and thanking the new Board and Committee
Members for their service and efforts on our behalf. A listing of the Board and Committee Chairs can be
found toward the end of Pharma Bulletin; membership experience can be greatly enhanced through
participation on one of our many committees. We encourage you to consider volunteering, the support and
assistance is always appreciated!
We held the very successful Professional Development Day (formerly Chapter Day), at the New
Brunswick Hyatt in early October, and you will find a more detailed reports within. While our personal
goals for involvement with ISPE may be predominately professional, we also enjoy socializing and
having fun along the way! Inside this edition, you will also find reviews of our most enjoyable night at the
Somerset Patriots game in July, as well as the first two of what are planned as many Therapeutic
Thursdays.
In an effort to encourage you to open and read though Pharma Bulletin and to have some challenging fun
while doing so, we are pleased to add a new feature to the newsletter, the Brain Puzzler. Each quarter,
we will include an interesting and thought provoking puzzle designed to tickle your brain.
A dinner meeting of the Chapter’s Executive Advisory Council (EAC) is being planned for January
2012, at an Owner company’s location. This meeting is by invitation only and comprised of senior
leaders from the manufacturing & operations areas of our member companies.
We look forward to seeing each of you at an upcoming ISPE event and continue to encourage your active
participation in our organization.
Paul Malinowski
Secretary- Board of Directors
New Jersey Chapter of ISPE
Harry Segner
Chair- Communications Committee
New Jersey Chapter of ISPE
Pharma Bulletin
President’s Message
Gordon Leichter, Ph.D.
ISPE NJC President
Where were you 25 years ago?
An innocuous question; but a very pertinent one? Take a moment for me and think back, where
were you, what was going on in your life, the world , our industry? Are you where you thought you
would be today? Even more important, where will you be tomorrow?
Okay, so I will try not to wax philosophical; but there were some famous milestones 25 years ago:
Figure 1 (The first mobile phone, Super Mario, Back to the Future, Ferris Bueller, Steve Jobs buys Pixar)
http://www.google.com/search?q=25+years+old...(Footnotes)
What was going on in our industry? Well there were a lot more pharmaceutical manufacturers, especially in NJ.
Figure 2 Consolidation in the Pharmaceutical Industry
http://en.wikipedia.org/wiki/List_of_pharmaceutical_companies
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Volume 18, Issue 3
And, I know you are curious where I was:
Figure 3 (Good friends from NJ circa 1986 –Wayne DeSantis,
Bob Topper, Jon Tomson, and me, all ISPE NJ Members)
So, what else happened 25 years ago? Well I am really glad you asked, because we are upon
the threshold of a very momentous milestone for the New Jersey ISPE Chapter. Yes, we are
celebrating our 25th anniversary as a Chapter. Tuck those thumbs up under your arm pits and
stand tall comrades, as New Jersey was the first Chapter to be started in the society. You can
read more about our history at http://www.ispe.org/new-jersey/chapter-history, courtesy of
Dr. Bruce Eckman
Figure 4 NJ Chapter Logos then and now
Wow, 25 freaking years ago!
So, woo-hoo!!! Here we all are sitting on the precipice of the future, our future. Where do we
go from here? What will the next 25 years bring, what will it look like? Well, some of us will still
be here, and hopefully one of you reading this will be writing that respective article. Most of
us will be still enjoying a quality life most notably due to the industry we have dedicated our
life’s to work in.
(Continued on Page 4)
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Pharma Bulletin
The next 25 years, a piece of cake; next 15 years, no problem; the next 10 years, hmm, should
be fine. But, what about the next five, three, or one year out? Not so easy for our industry, not
so easy for ISPE.
Yes, there has been a lot of lot of consolidation and attrition in our industry, see Fig 2. Sure,
there is enormous growth in emerging markets. However, where there are challenges lies
opportunities. The fabric of the ISPE NJC members has been built on tough challenges and
being resilient. The ISPE society was initiated in NJ (Eckman), and look what it has grown into.
Also, the good news is that the majority of the top Pharma companies are still located within our
region. This has help to keep a strong presence for the Pharma industry in our region, including
medium and small manufacturers.
While our Chapter and the entire ISPE society faces the challenges of changing times, we are
a group of doers, people who get up and get it done. The overall society has developed a five year
strategic plan to better meet the needs of our members. One aspect of this plan involves
delivering more value at the local level; it means more collaboration with the local Chapters. NJ
was the first to be involved with a pilot event that was held in September as a joint effort
between our Chapter and the International organization. This event went very well and is being
deemed a success.
I hope you were able to attend the above mentioned event. I hope you thought it was a great
event. Even, better… I hope that you had such strong feelings (good or bad) about this event
that you will step up and become an active participant in planning our Chapter activities. Even
better than that, I hope that you just are so motivated now that you just can’t wait to get
involved. Actually, I’ll share my vision for how the ISPE can excel as an organization through the
next five years… GET INVOLVED!
This is your society. This is your Chapter. Please join me and the other board and committee
members to make our society all it can be and more. You can start by attending over various
local and national events, including the Annual Meeting, which will be in Texas this November.
Events are a great place to interact with board and committee members and find out about
getting involved. Also, please keep an eye out for the announcement of our Gala 25th Anniversary
Bash coming in January. It will be a blast and a great celebration of our first 25 years as a
Chapter.
In closing, please remember, the society is all about you, and you get out of it what you put into
it. Please feel free to reach out to me with any comments, concerns, or interest in becoming
involved.
Onto the next 25……
Gordon Leichter, Ph.D.
President
ISPE NJC
Gordon.leichter@belimed.us
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Volume 18, Issue 3
Second Annual New Jersey Chapter
Night at the Ballgame
The second annual ISPE New Jersey Chapter
Night at the Ballgame was held on Friday, July
15th at TD Bank Ballpark in Bridgewater, NJ.
Approximately 50 members, guests and friends
of the Chapter enjoyed a beautiful night of
baseball while watching the Somerset Patriots
defeat the Camden Riversharks. Held in the
left field Picnic Area, the event included a
barbeque dinner and was followed by a very
enjoyable fireworks display, all allowing our
group to socialize, mingle and talk a little
business in a comfortable setting.
The event also supported the United Way’s
“Stuff the Bus” program by providing school
supplies and backpacks to needy students,
all through member donations. A great time
was had by all and we look forward to another
successful event in 2012.
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Pharma Bulletin
Joint Delaware Valley/ New Jersey Chapter
CPIP Study Group
A new initiative began this year between the New Jersey and Delaware Valley Chapters of
ISPE. In support of the ISPE certification program known as the Certified Pharmaceutical
Industry Professional (CPIP), ten individuals participated in a study group which would
prepare them for the certification process. The certification provides individuals the
opportunity to develop their careers and ultimately recognize their knowledge and skill set
in our challenging industry.
Robert Lechich, CPIP, from the New Jersey Chapter and Charles Clerecuzio, CPIP, from the
Delaware Valley Chapter, both of whom have obtained their CPIP certification, lead the group
which consisted of individuals from both Chapters and represented owner/operator, consulting
and vendor organizations. They met for ten weeks to complete eligibility requirements and
review the seven knowledge domains covered in the examination.
We are happy to report all the individuals have become eligible for the examination portion of
the certification. Stay tuned for updates on the candidates. We wish them luck in their
endeavor. A new study group will be beginning in the fall of 2011. Individuals interested in the
CPIP certification and the study group can contact Robert Lechich, CPIP,
(robert.lechich@pfizer.com) or go to the CPIP website at www.ispe.pcc.org for further information.
ISPE New Jersey Chapter would like to acknowledge
our Chapter Sponsor
for consistent support throughout the year
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Volume 18, Issue 3
ISPE NJ Chapter:
Therapeutic Thursdays - The Sequel
The second in what is turning out to be a favorite event sponsored by the NJ Chapter COP
Committee. On July 14th, over a dozen ISPE colleagues joined together for a night of low stress
networking and informal discussion, all over a few pints and appetizers at the Harvest Moon
Brewery in New Brunswick. A diversity of projects, backgrounds and issues were discussed.
All over a break from their regular routines…..with a couple hours of pub setting, and
yes…actually help getting some work done at the same time!
Be on the lookout for the next opportunity for you to join in on a future Therapeutic
Thursday event!
40 Under 40 Engineer 2011 Awards
Nandita Kamdar has been named by
Consulting-Specifying
Engineer
Magazine (CSE) as a 2011 40 under 40
honoree. This award is given to 40
building industry professionals age 40
and younger who stand out in their
academic, professional, personal, and
community achievements.
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Pharma Bulletin
ISPE New Jersey Chapter Young Professional News
The ISPE-NJ Young Professional (YP) group is very happy to have a place in the chapter! The
YP group has formed a committee and set goals for increasing membership and activity. The
YP short-term goals include recruiting members from ISPE active companies and holding local
informal YP gatherings. Any members who would like to be included in the YP group or know
professionals, either members or non-members, who might be interested in the YP group
should contact Katie Worden at keworden29@gmail.com.
BRAIN PUZZLER
A new feature to Pharma Bulletin begins with this issue. In each issue, you will find a
“Brain Puzzler” intended to challenge your knowledge, reasoning, common sense (and
maybe your engineering skills!).
We will provide this puzzle both in Pharma Bulletin and on the website and encourage
you to take a shot at the correct answer. Please submit your responses to the editor at
hsegner@ewingcole.com and make sure you put the phrase “Brain Puzzler” in the
subject line so your e-mail will be recognized as a response. We will announce and
publish the name of the first correct respondent in the following issue of the newsletter.
These Brain Puzzlers are being provided by our esteemed Chapter Secretary, Paul
Malinowski, whose evaluation of the winner is final ( we will leave out all of the legal
restrictions, clauses, etc….this is supposed to be fun! )
Puzzler Question: A pharmacist has 10 bottles of pills and each bottle contains
10 pills. All the pills in one of the bottles are defective. A regular pill weighs 5
grams, while the defective pills weigh 6 grams each.
The pharmacist tells her assistant to weigh a pill from each bottle to find the bad
batch. The assistant is a very clever Young Professional (YP) and figures out
which bottle is faulty by using the scale only one time. How does the YP do it?
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Volume 18, Issue 3
75 mile Multiple Sclerosis - City to Shore
NJ Chapter Board Member and Secretary Paul Malinowski (far left in photo) and Immediate
Past President Jim Breen (far right in photo) participated in the 75 mile Multiple Sclerosis City
to Shore charity ride on September 24th. They were joined by Brian Lipsitz and Nick Casale.
Paul and Jim represented the Renee’s Riders Team, which raised over $40,000.00 for MS
research.
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Pharma Bulletin
ISPE NJ Chapter at LifeCell
1st Learning and Networking Day
On September 21, the ISPE NJ Chapter participated in the 1st Learning & Networking Day,
held by LifeCell for their employees. The purpose of the event was to network and share
information about our organization with LifeCell employees. It was a unique opportunity to
connect and attract new members to ISPE.
The event started with a tour of their manufacturing facility, which was fascinating and
informative. Located in Branchburg, NJ, LifeCell is a recognized leader in regenerative medicine
providing innovative products for tissue restoration and replacement that deliver significant
clinical benefits. The day was filled with a constant flow of employees visiting the various
organization exhibits. In addition, there was an inspirational speaker and LinkedIn
demonstrations. There were several raffle prizes; a free membership was donated by ISPE.
It was very evident that the employees appreciated the opportunities that were offered to them
during this Learning and Networking Day and the ISPE NJ Chapter was happy to be invited and
to participate in such a rewarding special occasion.
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Volume 18, Issue 3
Professional Development Day a Success!!
In response to requests from members and engineering leaders, the New Jersey chapter is
focusing on providing professional development opportunities for our membership. Our first
big event, the first annual “Professional Development Day” was a success, providing industry
specific training with registered Professional Development Hours to meet the continuing
education requirements for licensed/certified professionals.
The two big attractions at the event “Reliability Engineering using a Lean Sigma Approach
“ and “Hot Topics in Automation” garnered over 20 participants for a day long dive into these
topical subjects. The big winners were the PE’s from New Jersey and Pennsylvania who
received 6 PDH, over 1/3rd of the new continuing education requirement, while getting training
that was directly relevant to their jobs.
More events are planned as the Professional Development and Certification Committee seeks to
provide you with the knowledge you need to do your job better and progress your career. Keep an
eye out for our new Webinar series, coming soon, as well as other full day training events.
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Pharma Bulletin
UPCOMING EVENTS
“The Future Isn’t What it Used to Be”:
The Path Forward for Pharma
On November 17th at the Bridgewater Manor, we will hear from Dr. Dennis
Gross, Associate Dean and Director at Thomas Jefferson University in
Philadelphia. Dr. Gross will be addressing drivers of the past and the new
drivers for the 21st century including the FDA’s perspective on why
productivity is not there. It is not just manufacturing costs but the entire
enterprise from discovery through to patent end of life that affects corporate
strategy, over-seas manufacturing.
Save The Date: December 8, 2011
2011 Holiday Party
The 2011 Holiday Party will return this year to Harvest Moon Brewery in
New Brunswick on December 8th. Again, the NJ Chapter will sponsor a
“Toys for Tots” holiday gift drive during the event and encourage you to
bring along an unwrapped toy to help a less privileged youngster enjoy
their Holiday. We look forward to seeing you there!
25th Anniversary Celebration Gala
Plans are now being finalized for the NJ Chapter Celebration Gala, to
be held in January of 2012! This will be a once in a career
opportunity for all of us to celebrate and to remember that our
Chapter was the FIRST ISPE Chapter to be formed, in 1986. Join
several of the founding Chapter Members, whether you have been a
member for 25 weeks or all 25 years for this outstanding and elegant
event. Stay tuned for the particulars, which should be available
within the next few weeks.
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Volume 18, Issue 3
“Build a Lab”
Brought to you by the same NJ and Delaware Valley Chapter Members
who successfully introduced the concept at last year’s ISPE Annual Meeting
in Orlando, this interesting and fun event combines teams of professionals
from various disciplines to work together during the evening to plan and
execute a hypothetical project. The “catch” is that you will most likely be
randomly assigned to a different role than the one you play in your everyday
job….a VP of Engineering at an operating company may be responsible for
making the decisions of the equipment supplier or the construction
manager or vice versa!! Plan on joining us in February for an enjoyable
and informative evening of “role playing” and learning.
Genzyme Plant Tour and
Owner/Vendor Presentation
Plans are underway for the always popular plant tour and owner/vendor
presentation at Genzyme during the month of March.
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Pharma Bulletin
ISPE NEWS
FOR IMMEDIATE RELEASE
For more information contact:
Danielle Hould
ISPE Communications Manager
Tel: +1-813-960-2105, ext. 277
email: dhould@ispe.org
www.ISPE.org
ISPE Expands Commissioning and Qualification Guidance Series
—New Guide bridges gap between Baseline® Guide and
full ICH Q8, Q9, Q10 adaptation—
(TAMPA, FLORIDA, USA, 18 October 2011) – ISPE, a global not-for-profit association of 22,000
pharmaceutical science and manufacturing professionals, today announced that it has released a
new guidance document on pharmaceutical commissioning and qualification entitled, ISPE Good
Practice Guide: Applied Risk Management in Commissioning and Qualification. This new Guide
successfully provides a bridge between the baseline strategies outlined in the ISPE Baseline® Guide,
Volume 5: Commissioning and Qualification and the more advanced strategies prescribed in the
ISPE Guide: Science- and Risk-Based Approach for the Delivery of Facilities, Systems, and
Equipment.
“With the rapid changes currently underway in the pharmaceutical industry, it’s becoming more and
more common to find companies at all points of the continuum when it comes to commissioning and
qualification best practices,” said Steve Wisniewski, one of the Guide’s authors. “ISPE recognized the
necessity of having available guidance to answer questions across the entire spectrum from Baseline
to full ICH Q8, Q9, and Q10 adaptation. While the ISPE Baseline Guide, Volume 5 remains relevant
and is still a viable option, the ISPE Good Practice Guide: Applied Risk Management in
Commissioning and Qualification serves as an excellent resource for companies that would like to
incorporate some elements of Q8, Q9, and Q10, but do not wish to move to full implementation at this
time.”
The ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification
describes how organizations can move from established baseline practice to a more efficient scienceand risk-based framework. It illustrates the application of Quality Risk Management to traditional
commissioning and qualification practices, linking traditional terminology and approaches to the
newer science- and risk-based specification and verification terminology and approaches applied in
ICH Q8, Q9, and Q10, ASTM E2500, and ISPE Guide: Science- and Risk-Based Approach for the
Delivery of Facilities, Systems and Equipment.
(Continued on Next Page)
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Volume 18, Issue 3
The approach described in the ISPE Good Practice Guide: Applied Risk Management in
Commissioning and Qualification allows companies to achieve the benefits of a science- and riskbased model by outlining bridging strategies for organizations with well-established qualificationbased Quality Management Systems and providing a roadmap showing the spectrum of potential
approaches for this transition.
In a further effort to assist companies in transitioning from traditional impact assessment-based
qualification approaches to ICH Q9 QRM-based approaches found in ASTM E2500 and the ISPE
Guide: Science- and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment
Guide (FSE Guide), ISPE will now include Appendix 2 from the FSE Guide with purchases of the
Baseline Volume 5 document. The Appendix contains an update for use with the Commissioning and
Qualification Impact Assessment Chapter of the Baseline Guide, based on the experiences of project
teams and considers the benefits and application of science-based process understanding. By
including the Appendix, ISPE hopes to provide an additional value to those purchasing the Baseline
Guide Volume 5 by showing an updated approach to impact assessments.
The ISPE Good Practice Guide: Applied Risk Management in Commissioning and Qualification was
launched as part of the ISPE Brussels Conference, which took place in September in Brussels,
Belgium. Educational content related to the Guide also will be featured at the 2011 ISPE Annual
Meeting, taking place 6-9 November 2011 in Grapevine, Texas, USA.
For more information on the ISPE Good Practice Guide: Applied Risk Management in
Commissioning and Qualification, or to order a copy in either bound or electronic form, visit
www.ispe.org/ispe-good-practice-guides/applied-risk-management-cq.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is a Society of 22,000
pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, costeffective GMP solutions. ISPE is “Connecting a World of Pharmaceutical Knowledge” by providing
Members with opportunities to develop their technical knowledge, exchange practical experience
within their community, enhance their professional skills, and collaborate with global regulatory
agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a
global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in
Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China.
Visit www.ISPE.org for additional Society news and information.
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Pharma Bulletin
ISPE NEWS
FOR IMMEDIATE RELEASE
For more information contact:
Danielle Hould
ISPE Communications Manager
Tel: +1-813-960-2105, ext. 277
email: dhould@ispe.org
www.ISPE.org
ISPE Announces 2011-2012 Board of Directors Election Results
(TAMPA, FLORIDA, USA, 20 OCTOBER 2011) – ISPE, a global not-for-profit association of 22,000
pharmaceutical science and manufacturing professionals, has announced the results of its 2011-2012
International Board of Directors election, revealing a slate of representatives that hail from nearly every
corner of the globe.
The following pharmaceutical industry professionals have been elected to positions on the 2011-2012
ISPE International Board of Directors:
Arthur “Randy” Perez, PhD, Chairman – Dr. Perez currently holds the position of Director, IT Risk
Management and Compliance for Novartis Pharmaceuticals. Dr. Perez was instrumental in the
formation of GAMP Americas when that group started in 2000, and served as Chairman from 20022008. He initiated and led the Global Information Systems SIG, who wrote a GAMP® Good Practice
Guide that was published in 2005, and was part of the core team that led the development of GAMP® 5,
published in 2008. In 2005 he was elected to the ISPE International Board of Directors, most recently
serving as Vice Chairman.
Charlotte Enghave Fruergaard, PhD, Vice Chairman – Dr. Enghave Fruergaard is employed as
Director of Technology, Process and Compliance, at NNE Pharmaplan in Denmark. Enghave
Fruergaard has been a Member of ISPE since 1995, and is the current Treasurer on the International
Board of Directors. She co-founded the ISPE Nordic Affiliate in 2000. She chaired ISPE’s Board
Working Group on Organizational Restructuring in 2011, and she is currently a member of ISPE Sterile
Products Processing COP steering committee as well as on the Editorial Board for the magazine
Pharmaceutical Engineering.
Damian Greene, Treasurer – Mr. Greene is Senior Director Network Strategy for Pfizer Global Supply
in New York. Greene has served as Chair of the ISPE Community of Practice Council and as Chair of
the API COP. Greene most recently served as Secretary of the ISPE International Board of Directors.
Brian H. Lange, PE, Secretary – Mr. Lange is PMO Operations Director, North American Operations
and Merck Consumer Care for Merck & Co., Inc. Mr. Lange has been an active Member of ISPE for
over 20 years. He is a Past Chairman of the International Board of Directors and has served as Chair
on several International Committees, including Education, Technical Documents, and Chapter Council,
and currently serves on the judging panel for the Facility of the Year Awards program.
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Volume 18, Issue 3
Re-elected Directors:
Doyle Johnson – Mr. Johnson is a consultant to the Biopharmaceutical industry. Previously he was
the Senior Director of Facilities Operations at Genzyme’s Biologics Division. He has served as
President of ISPE’s Boston Chapter during the year in which the Chapter was named Chapter of the
Year. Prior to becoming Chapter President, he served five years on the Chapter’s Board of Directors.
Morton Stenkilde – Mr. Stenkilde is the Quality Director for Novo Nordisk A/S’s Insulin Filling plant in
Tianjin, China. Stenkilde is a Member of the Executive Committee of the Board for the ISPE Greater
China Affiliate. He is developing a Community of Practice for sterile manufacturing in China and
serves as Co-Chair of ISPE’s Board Working Group on Asia Pacific Strategy.
New Directors:
James A. Breen, Jr. – Mr. Breen is the Vice President of Project Management in Johnson &
Johnson’s Worldwide Engineering and Technical Operations Group. Mr. Breen is the immediate Past
President of the ISPE New Jersey Chapter, a Member of the Facility of the Year Awards judging panel,
and a Member of the Society’s Marketing Advisory Council.
Tim Howard, CPIP, PE – Mr. Howard is a Vice President and Company Officer at Commissioning
Agents, Inc. Mr. Howard has been a Member of ISPE since 1994. He is a Member of ISPE’s Future
Visioning Team, Chair of the ISPE University Committee and Co-Chair of the Commissioning and
Qualification Community of Practice. Previously, he has served on the Board of the Carolina/South
Atlantic Chapter, and as Chair of the North American Education Committee, on which he has served
as a long-time Member.
Andrew D. Skibo – Mr. Skibo is the Executive Vice President of Operations at MedImmune. He has
been a Member of ISPE for 22 years. Mr. Skibo currently serves on the judging panel for the Facility
of the Year Awards and as a Member of the International Leadership Forum.
Udo J. Vetter – Mr. Vetter currently holds the position of Chairman of the Control Board of the Vetter
Group of companies, a specialty CMO. He was co-founder of ISPE’s German-Swiss-Austrian Affiliate
in 1991 and served three years as Affiliate Chair. He has been a Member of the International
Leadership Forum for the last 15 years, and currently serves on the Society’s Future Visioning Team.
In addition to those named above, Directors Joe Famulare, Gordon Leichter, PhD, Steve Tyler,
and Guy Wingate, PhD, each of whom were elected in 2010 to serve a two-year term, will continue
their service on the Board. Complete biographical information on all of ISPE’s Directors can be found
at the ISPE Board of Directors webpage.
About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is a Society of 22,000 pharmaceutical
professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP
solutions. ISPE is “Connecting a World of Pharmaceutical Knowledge” by providing Members with
opportunities to develop their technical knowledge, exchange practical experience within their
community, enhance their professional skills, and collaborate with global regulatory agencies and
industry leaders. Founded in 1980, ISPE offers online learning opportunities for a global audience and
has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an
Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for
additional Society news and information.
Page 17
Pharma Bulletin
Career Doctor Don Answers Your Questions
Don Sutaria is Founder and President of CareerQuest, located in New
Jersey and New York. Don earned his MS degree in Management from
Kansas State University, an IE (Professional) degree in International
Management and Personnel Relations from Columbia University, and
obtained New York University’s postgraduate Certificate in Adult
Career Planning and Development. A popular speaker and author, his
latest book is titled, Career and Life Counseling From the Heart (Your
Career is a Pathway to Your Soul!).
Question: I have been trying to get a job in engineering for the past year but have been unsuccessful in spite of
my best efforts, following conventional advice. Can you suggest new and innovative techniques for résumés,
cover letters, interviews and salaries which could end this stalemate?
G. K. S. (Edison, NJ)
Answer: Dear G. K. S.:
These are definitely tough times for job hunters. I haven’t seen so many qualified professionals struggling to get
jobs, during the past four decades! So, take heart. It’s not all you.
Based on some unconventional approaches, I can offer you a few suggestions worth trying.
Résumés and Cover Letters
1. Establish yourself as an independent contractor or consultant in your field. Print up business
cards and have a separate business telephone line, landline or mobile, with voicemail and caller
ID. If you have been out of work for more than six months, you are suspect, and considered ‘damaged
goods’. Interviewers sometimes mistakenly assume you have been passed over or have been fired
due to personality conflict. So, why should they bother with you when they have so many candidates
to choose from?
During this transition period, settle for paid or unpaid internships, or volunteer in organizations.
You can use these experiences to fill in the time gap during your job search, paid or unpaid. You do
not have to reveal your compensation unless specifically asked.
2. If an employee of a company hand carries your résumé to the human resources department, it
carries a lot of weight. Your chances of getting an interview are greatly improved.
3. Ensure that your e-mail conveys a professional image. Something like JerseyShoreJohn@gmail.com
is unacceptable.
4. Your résumé should contain as many key words as possible, pertaining to the job description
or the job advertisement. Without that the automated applicant tracking system may not even
surface your résumé for consideration.
5. Your cover letter is like a ‘gift wrapping’ for your résumé. It should go to a specific person.
A one-page limit should be observed. Four paragraphs would be ideal. The second and third
paragraphs should be hooks with specific experiences which would interest the prospective
company. Do not repeat what is in the résumé.
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Volume 18, Issue 3
6. Do not fold the cover letter and the résumé, but send them flat in a 9" x 12" envelope. Ugly
lines appear on the scanned copies where the creases are. It also sets you apart from other
candidates.
Interviews
1. Study up on the company before the interview. It will enable you to talk like an insider. It
also shows genuine interest in the company you are interviewing.
2. Do not reveal any personal information about you which could hurt your chances. Sensitive
areas are physical and mental health, and also young kids in the family. Some people don’t
want to hire people with young kids, assuming that their absentee rates may be high.
3. Believe it or not, it is harder to get hired if you are overweight or obese. Interviewers make
snap judgments based on stereotypes. Such people are considered as undisciplined and out of
control. Perhaps appropriate clothing may help camouflage some of the body shapes.
4. A limp-fish weak handshake projects a lack of confidence or extreme introversion.....a strike
against you.
5. If an interviewer dominates the conversation for 45-60 minutes, be patient and listen.
Perhaps he/she is a talkative person, but you will come out ahead in the interview, as a great
candidate!
6. Separate thank-you notes to all the people who interviewed you are a must. This may be the
last chance to sell yourself, in case you have forgotten to mention a relevant experience during
the interview. You can send them as e-mail or through regular mail. You would be surprised to
hear that less than 10% of candidates send these thank-you notes after their interviews.
Follw-up after that is very important.
Salaries
1. Be aware of comparable salary ranges for your type of a job at other organizations. Use
Salary.com as a guide.
2. Do not talk about salary until you reach the final stages and it appears you have a good fit
for the job. The party that gives out the salary number first loses negotiating power.
3. If the company’s hands are tied in terms of salary and you really like the job, negotiate nonfinancial benefits like an extra vacation week or up-front joining bonus.
4. You as a candidate should do all the salary negotiations. Would you believe some helicopter
parents have tried to intervene with human resources? It is a kiss of death.
Innovative and Unorthodox Job Searches
Please keep in mind that these unconventional methods have to be used with utmost care and
professionalism, so that you can be remembered for the right reasons.
(Continues on Next Page)
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Pharma Bulletin
1. An advertising executive had a sign on the front and back of his t-shirt, This Space Available!
2. A copywriter set up shop on a sidewalk with a folding desk and cell phone as a contact
number.
3. A marketing candidate made a DVD with his achievements on it and distributed it free; cost:
$1,500.
4. A whole graduating MBA class called themselves Marketing All Stars, instead of boring
résumés, placed the synopsis of their experiences on baseball type trading cards.
5. A creative marketer dropped his one-page résumé in leaflet form from a hot air balloon.
6. An enterprising candidate in the field of arts rented a theater marquee, on which he placed
brief statements of his achievements and his telephone number.
7. A writer had inexpensive baseball caps made with the saying, I will not drop the ball!
8. A bold candidate sent a prepaid breakfast to the interviewer’s office before the interview.
9. Over a weekend, a potential candidate left post-hypnotic suggestions to hire him, on the
interviewer’s voicemail.
10. Another candidate stood on the street with a placard hanging around his neck, showing the
highlights of his accomplishments.
11. Many executives are commuters to a city, taking trains. Résumés were handed out by one
job seeker at the main train stations.
12. If you hang around careers section at Barnes & Noble, and strike up conversations with
like-minded people in similar situations, you may be amazed at the number of live job leads you
can gather. Of course, reciprocation is needed!
13. Make follow-up telephone calls to hiring managers between 7:00 a.m. and 8:00 a.m. when
they are most likely to pick up their phone, before their administrative assistants arrive. Try
again between 5:00 p.m. and 7:00 p.m., a time slot when executives may be working late, but
their assistants have left for the day. Leave pleasant and positive voicemail messages if necessary,
and be persistent in your follow-ups, calling at least eight times!
14. Self-help job-search groups meet at churches, synagogues and temples, at convenient
times in the evenings. Join at least one, which will give you moral support as well as job leads
through the networking process.
15. At a networking meeting/mixer, one job seeker had his condensed résumé printed on
cocktail napkins.
16. A private duty registered nurse who was in career transition, printed a t-shirt with her web
site and contact information and wore it all the time when she was running outside chores.
17. A financial executive had his condensed résumé on the front of his shirt and a brief cover
letter on the back.
(Continues on next page)
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Volume 18, Issue 3
18. A job seeker sent a cake designed as a business card with his picture.
19. One candidate gave out personalized coffee mugs.
20. Another candidate handed out résumés at a stoplight near his intended place of work.
21. One interviewee appeared in a bunny outfit because it was so close to Easter.
22. One prospective candidate found out where the hiring manager went for a haircut and
followed suit. The job seeker asked the barber to informally introduce him to the manager,
which he did.
23. A hiring director was jolted when he received a shoe from an advertising candidate, with a
résumé in it, and a note saying, I would like to get my foot in your door!
24. A determined candidate offered to wash cars for free in the company parking lot, to show
that he was not too proud to do anything assigned to him.
Dear G.K.S., Trifles lead to perfection, and perfection is no trifle! Good luck.
[Special note: Please send your career-related questions to don@careerquestcentral.com and also visit our
website at www.careerquestcentral.com. Questions will be selected based on their contemporary nature and
general interest. We regret we will not be able to send individual replies as in the past, because of the large
volume of domestic and international e-mails. Your patience and understanding are appreciated.]
ISPE NJC Welcomes 32 New Members
Isaac Aboh, Manhattan College
Ivwede Akpobo, Student
Dennis Boles, Johnson Controls, Inc.
Joseph Carney, Manhattan College
Carol Cruz, Manhattan College
Jonathan Cursi, Rutgers University
Crystal Fisher, Manhattan College
Ivan Gajic, University of Rhode Island
Dyke Gill, Montclair State University
Ceikia Hill, Pfizer
Adrian Hot, Manhattan College
Daniel Kilerciyan, Manhattan College
Anant Kulkarni, Merck & Co.
Derek Lapinska, AICHE, SBE New Technology
John Laucius, Merck
Kevin Lee, Lehigh University
Nirav Patel, Stevens Institute of Technology
Stephanie Piantedosi, University of Rhode Island
Alessandra Piazza, Manhattan College
Andrew Pierro, Burkert Fluid Control Systems
Nicholas Semenza, Manhattan College
Andrew Sgarlato, Lehigh University
Max Skula, Rutgers University
Matthew Sleeper, Merck
Divya Sunkara, NJIT
Michelle Togba, University of Rhode Island
Deirdra Vachal, XTrials Research
Bhargavi Veeramachaneni, NJIT
Justin Vento, Manhattan College
George Wafula, Montclair State University
Abdallah Walaa, Manhattan College
Thomas Woody Jr., ARx, LLC
Page 21
Pharma Bulletin
The ISPE New Jersey Chapter 2011/2012 Board of Directors
OFFICERS
President
Executive VP
Vice President
Treasurer
Secretary
DIRECTORS
Engineering Rep
Pharma Rep
Vendor Rep
QC Rep
Representatives at Large
Gordon Leichter, Belimed, Inc., 585/329-0497, gordon.leichter@belimed.us
Antonio Crincoli, Bristol-Myers Squibb, 732/227-5353, tony.crincoli@bms.com
Scott Hickok, EMCOR Energy Services, 203/536-5219, scott_hickok@emcorgroup.com
Nandita Kamdar, PS&S, 732/584-0449, nkamdar@psands.com
Paul Malinowski, Becton Dickinson, 201/847-7041, paul_t_malinowski@bd.com
Jeff Fedor, CRB, 610/278-76441, jeff.fedor@crbusa.com
John Perrique, Johnson & Johnson, 732/524-6393, jperrigu@corus.jnj.com
Andrew Harlow, SBB, Inc., 631/862-6261, aharlow@sbbinc.com
Nancy Tomoney, PSC BioTech, 732/640-1177, ntomoney@biotech.com
Lorraine Gallo, PS & S, 732/584-0386, lgallo@psands.com
Norman Goldschmidt, Pharma Engineering Advisors, 609/468-5704, ngoldschm@aol.com
Paul Melamud, Qpharma, 973/462-2653, paul.melamud@qpharmacorp.com
Michael Picariello, Shire Human Genetic Therapies, 609/466-4118, mpicariello15@gmail.com
Margaret O’Toole, Pfizer, 845/602-1325, margaret.otoole@pfizer.com
Stephen Fowler, Process Equip. Res. & Consulting, 908/458-6478, proequi@optonline.net
Awards Committee
Steve Fries, 908/892-9064, stephen.p.fries@gmail.com
Harry Segner, Ewing Cole 215/923-2020, hsegner@ewingcole.com
Comm. Commitee
EAC (Exec. Advisory Counsel) Paul Malinowski, Becton Dickinson, 201/847-7041, paul_t_malinowski@bd.com
Prof. Dev. & Cert. Committee Norman Goldschmidt, Pharma Engineering Advisors, 609/468-5704, ngoldschm@aol.com
Prog. Committee, Co-Chair
Michael Picariello, Shire Human Genetic Therapies, 609/466-4118, mpicariello15@gmail.com
Prog. Committee, Co-Chair
Marketing /Membership
Student Affairs Co-Chair
Student Affairs Co-Chair
Young Professionals
Nominating Comm. Co-Chair
Nominating Comm. Co-Chair
Technology Committee
Jeff Fedor, CRB, 610/278-76441, jeff.fedor@crbusa.com
Lorraine Gallo, PS & S, 732/584-0386, lgallo@psands.com
Joe Manfredi, GMP Systems, 973/575-4990, jjm1152@aol.com
Robert Lechich, CPIP, Pfizer, 978/247-4513, robert.lechich@pfizer.com
Kaitlin Worden, Regeneron Pharmaceuticals, 914/298-5396, keworden29@gmail.com
Bruce Eckman, WBE Consulting, 732/704-9800 x226, bruceeckman@gmail.com
Dragutin Stoicovici, Cozzoli Machine Co., dstoicovici@quality21.com
John Perrique, Johnson & Johnson, 732/524-6393, jperrigu@corus.jnj.com
Past Presidents Committee
Chris Martinson, Whiting-Turner Cont’g Co., 732/805-0420, chris.martinson@whiting-turner.com
Community Affairs
Stephen Fowler, Process Equip. Res. & Consulting, 908/458-6478, proequi@optonline.net
Chapter Manager
Caroline Shelly, Hunterdon Facility Planners, 908/393-9984, ceshelly@comcast.net
ISPE Int’l Board Lisison
COP - Chair
(Communities of Practice)
Critical Utilities
High Potency/Containment
Biotechnology
C&Q
HVAC
GAMP
Sustainability
Sterile Process
Page 22
ISPE New Jersey Chapter, 908/393-9984, manager@ispenj.org
Gordon Leichter, Belimed, Inc., 585/329-0497, gordon.leichter@belimed.us
Antonio Crincoli, Bristol-Myers Squibb, 732/227-5353, tony.crincoli@bms.com
Joe Manfredi, GMP Systems, 973/575-4990, jjm1152@aol.com
Walter Fedick, Hoffman-LaRoche, walter.fedick@roche.com
Joe D’Amore, The Amore Group, 908/541-8104, joseph.d’amore@imclone.com
Aaron Weinstein, IPS, 732/748-1990 x214, aweinstein@ipsdb.com
William Gantz, Bristol-Myers Squibb, 732/227-5275, william.gantz@bms.com
Dragutin Stoicovici, Cozzoli Machine Co., dstoicovici@quality21.com
Paul Malinowski, Becton Dickinson, 201/847-7041, paul_t_malinowski@bd.com
Gordon Leichter, Belimed, Inc., 585/329-0497, gordon.leichter@belimed.us
Volume 18, Issue 3
ISPE-NJ Pharma Bulletin Ad Rates
The New Jersey Chapter of ISPE Newsletter,
the Pharma Bulletin, is published
(electronically) on a quarterly basis and
distributed to all Chapter members via e-mail.
Individual Issue Advertisements: $200.
Four consecutive ads: $600.
For more information on advertising in the
Pharma Bulletin, contact the ISPE-NJ Chapter
Manager at manager@ispenj.org.
For information on Sponsorship opportunities for
Chapter programs and events, contact Marketing
Committee Chair, Lorraine Gallo, at
lgallo@psands.com.
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