Description
Project management is the discipline of initiating, planning, executing, controlling, and closing the work of a team to achieve specific goals and meet specific success criteria. A project is a temporary endeavor designed to produce a unique product, service or result with a defined beginning and end (usually time-constrained, and often constrained by funding or deliverables) undertaken to meet unique goals and objectives
Reprinted from PHARMACEUTICAL ENGINEERING
®
The Official Magaine of I!PE
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This article
presents
-Cop.right I!PE $%&&
Pro/ect Management !trategie0 for
m
ethods
and tools for
M1lti2Compan. Pro/ect Team0
successfully
managing
projects
where team
members are
from
multiple
and sometimes
competing
by Mark Mathis
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significantly adding overhead costs. By "cherry
picking" individuals with backgrounds best suited
to the scope, clients can offset the risks of a single
company's shortfalls in personnel.
This scenario does not always provide for a
ceutical/biotech industry have come to enoy
the advantages of assembling proect teams with
e!actly the individuals they need from multiple
sources. There are risks and liabilities that
accompany such decisions, but overall, this helps
keep the market competitive for all service
providers. This shift in resource availability brings
a paradigm shift in how all companies must
e!ecute proects.
"or those who have worked in large and
small#rchitecture and $ngineering %#&$' firm
environments, there is a significant adustment
made when switching between the two. (arger
firms have more established guidelines on how
work is to be performed and by what criteria
specific deliverables are completed. These work
practices can span several industries that the larger
firm services with the idea of creating continuity in
a diverse, more proect fle!ible workforce. )maller
firms have the fle!ibility and freedom to cross
over inter*disciplinary boundaries and by
necessity, must sometimes e!ecute work outside of
their comfort +ones or technical background.
,hat seemed a great divide -. years ago in the
two
operating
philosoph
ies has
now been
pulled
together
to form
the hybrid
proect
team. This
is the
team
where
several
players
from
different
organi+ati
ons are
made to
work
together
to
complete proects as a group. ,hile it does happen
that these hybrids form at the larger /-.. million
plus proects, it is more
lower capital cost for services. To the contrary,
choosing select professionals from multiple firms
will result in the highest Time and Materials
%T&M' rates per person. ,hat is diluted is the need
for e!cessive overhead and administra* tive cost.
0lients with a solid administrative infrastructure
can offset this cost by includ* ing direct personnel
to help with establishing and managing travel
guidelines and e!pense reimbursements. #lso,
integrating members of a client's internal proect
team with the group will result in increased
efficiency in communica* tions and schedule
alignment among all team members.
1n this environment, proects can be derailed by
taking the wrong approach to managing the team
early on. 2isks include larger firms trying to force
their own governing work protocols on everyone
else, individuals acting as lone*wolfs working in
bubbles and not communicating with the group,
and an increased likelihood of defection from key
personnel.Much of this comes down to the
personalities of those involved, but there are
practical and successful strate* gies that if
implemented early on will result in more managed
scope control, higher retention of the core team,
and a significant reduction in encountering the
aforementioned risks along the way.
The concepts address in this article are as
follows3
common to see it at the less than /4. million -. 1dentify Team 5layers
Total 1nstalled 0ost %T10' obs. The rationale is 6. 1dentify the 5roect 0ulture
simple,smaller,more diverse,and focused teams 7. 1dentify Technical 2esources
will bring a wide breadth of e!perience without 8. 0ommunication
September/OctOber 2011 PHARMACEUTICAL ENGINEERING 1
project management Strategies
Strategy 1 - Identify Team Players
$ncountering non*9ualified individuals on proect teams and
reali+ing it a little too late is one of the more common risks all clients try
to avoid. :verstated or embellished resumes can appear from large and
small companies alike.Be on the lookout for inter*corporate nepotism as
well. This can be especially common in proects where large proect
teams are relocated to obsites. 0orporate teams will naturally want to
surround themselves with friends and their own known 9uantities.;on't
assume that educational background was verified and check if the
background seems appropriate for the positions held within the company
or on the proect. There can be managers of engineering staff who do not
have an engineering degree, or other applicable e!perience other than the
relationships with senior staff. 1n some states, you cannot add "engineer"
to a title unless there is a relevant engineering degree and in some cases a
regional license. This is not to say that all positions re9uire degrees, but
be discriminating with relocating proect teams. The #&$'s goal is to
provide the right person, but often has to choose from a shallow pool of
those employees who are willing to relocate. )et a proect standard for
background checks and degree verifications for everyone regardless of
affiliation.This helps minimi+e what has become known as "empire
building" on proects where the priorities tend to shift away from the
proect and more toward the individuals involved.
#nother risk common in this scenario is personnel hired solely for the
purpose of relocating. 1f you are considering a contract with any firm that
includes relocating staff,you should e!pect personnel that are e!perienced
with that company's policies and loyal to representing them even when
away from the corporate home front. # senior e!ecutive brought on to
pad a ob with years and years of e!perience but no ties to the
organi+ation and a history of umping companies can 9uickly poison
the well for other members of the team. This too can turn into empire
building which will only serve the goals of the empire and not the
proect.
)maller firms will have every motivation to put their best face
forward, but may not reali+e the advantages of integrat* ing with others.
1t is easy to default to posturing and e!ag* geration of capabilities
instead of identifying areas where they need support from others. Be
aware of those that would propose to hold any technical role on a
proect. # small firm or individual should be fle!ible, but should have
some area of e!pertise and a willingness to shore up the places where
they are not as e!perienced. 1n fact, this is the primary advantage of
assembling a team from multiple organi+ations.
There should be one flag for any proect team. )ince team members
may originate from several different entities,a single governing set of
directives that is aligned with the proect obectives should be in place
and managed by the team leader. 1f possible, become familiar with
what the internal goals or employee incentives that may be in place at
the different firms. Make sure these will align with proect
e!pectations. There are several technical strategies to defining the way
a proect will be e!ecuted but first, the hard part< identifying the proect
team's culture.
Strategy 2 - Identify the Project ulture
,hat is it about our industry that remains constant regardless
of the company you work for or the products you help produce= 1t is the
culture of that organi+ation that defines, enhances, or limits the ability of
the group to achieve success. There are many uni9ue characteristics of the
pharmaceutical, and more specifically,the biotech arena that set it apart
from other multi* billion dollar industries. :ne that stands out is the fact
that biotech itself is still an ever e!panding and new marketplace. >aving
not been around near as long as the food and beverage, polymer,
semiconductor and a host of other similar product driven groups< biotech
has 9uickly set the pace of continually redefining itself every few years.
$!isting drug products are being manufactured more efficiently and
becoming safer to produce and consume< and new drugs are pushing the
enve* lope of what manufacturing and design tools are out there to
formulate the product and increase speed to market.
1f a hierarchy of culture were assembled for the biotech industry, it
would include the fact that our media age con* tinues to be one of the
youngest, second only to $commerce< our workers and service providers
can 9uickly set themselves apart as generators of new ideas and specialists
in new areas of e!pertise< that the very core products are themselves a gen*
erous payback to those that work in the industry, striving to better the
9uality of life for friends, families and in most cases strangers around the
globe. ,hen speaking to those still in school, this culture is the easiest to
convey because there are ust a few professions that are as e!citing and
fulfilling as the pharmaceutical/biotech industry. ?o student can resist
even the very basic principles of @"5s @reen "luorescent 5rotein %@"5s'
and watching mice and other mammals glow under a black light.
0ombine that and other e!citing technological advancements with the
fulfillment of serving the sick and reducing the spread of disease
worldwide, and you have an interested and engaged pupil.
Anderneath the culture of the industry resides the culture of the
individual company. This can be a manufacturer, a con* sulting group, or
any number of service providers that work in the field. The first maor
challenge of working with a new client is determining what their culture
is. This is more than a mission statement, it defines their community and
ultimately what their priorities are. There are vast differences between
company cultures that become evident after spending time with many of
the larger drug makers. There are regional in* fluences in west and east
coast businesses and depending on the drugs produced< there are
differences in attitudes about manufacturing< there are campuses that
resemble colleges and parties and events that would impress even the
coolest "acebook employee. ,orking at an acetaminophen plant will
highlight the e!treme difference between making aspirin additives in
large bulk 9uantities and making a drug that only applies to a select
market of consumers. The employees, the packaging, and very processes
are all very distinct to the culture of the company where the drug is
made.
The reason all of this becomes important to consider as part of aTeam
(eadership paradigm is that the culture of operations e!tend throughout
all uni9ue companies, but none is more
2 PHARMACEUTICAL ENGINEERING September/OctOber 2011
project management Strategies
challenging and ever changing than that of the small business facility and e9uipment. Material and personnel flows, s9uare
consultant. (arger engineering firms that service multiple footage and throughput are critical to establish and set the
industries where biotech is but a small sector, cannot afford groundwork for the preliminary and detailed design teams to
greatly deviate the process by which they e!ecute proects. to gather information for their respective disciplines. ,here #n
engineer or manager working in the biotech sector one day large groups of engineers maintain a respectable catalogue may be
working in the petroleum group the ne!t, especially of past proects, computer programs, and other resources to those
who work on the infrastructure or non*process driven draw from, it may be cost prohibitive for a client to bring them side.
>owever, the smaller companies, specifically those that on board, or more likely, teams are now cherry picked from a
choose to focus on the pharmaceutical/biotech industry alone, variety of organi+ations where issues of intellectual property must
constantly reevaluate the respective client's culture with prohibits an open and sharing environment. 1n the absence of every
proect. This is a more intimate environment where more traditional resources,coming up with uni9ue proect tools
more often than not, consultants are brought into the fold of for the team can be challenging. These tools need to not only a
clients operating group. $ven going so far as to integrate streamline the more mechanical operations %like datasheet and them
into site specific training, access to facilities and perks, specification assembly', but make communication of technical
and internal metrics by which performance is rated along side and commercial data more efficient.
of full time employees. The relative cost of failure was mentioned in one of this
)o in this rapidly changing environment, how does a small year's earlier articles on risk assessment and also has great
company navigate the different modes of operation within a relevance for this topic. The primary goal of a proect team
changing client roster, while simultaneously establishing a is not to e!ecute perfectly, but to properly evaluate risk and uni9ue
identity in this environment= )omething that becomes identify problems as early in the proect as possible, knowing
apparent when an engineer leaves the fold of a big company, is that failure costs increase e!ponentially with time.
that the workload and responsibility matrices begin to flatten.
The lines of segregating interdisciplinary tasks and obectives A. Multi-User Project Database
are no longer clearly marked. # process engineer must now "or process engineers who must now manage e9uipment, a
understand e9uipment and procurement< a mechanical de* customi+ed database application can be a good place to start.
sign engineer must now route pipe and duct alike< a controls The days of $!cel's large, multi*layer worksheets with count*
engineer has to step outside of the programming bubble to less embedded calculations referencing obscure and sometimes
consider people and material flow and locate shared, multi* hidden cell locations are phasing out. #s these programs are
purpose operator interface stations or :1Ts. passed on or reused, they can't help but bring the old proect
1dentifying and understanding the client's culture is a key problems into the new proect. Too often there is only a single
first step in any team's success. 1t is e9ually the responsibility individual who may no longer be with the organi+ation that
of the client to communicate this to the group, understanding even knows the details of the programs design, fudge factors,
that those not in the fold may not be aware of what happens or macros. ,hile creating a database management system
behind the scenes. The leadership of the team should take an does come with its own set of challenges and frustrations, a
active part in making sure everything is communicated and very powerful advantage is the ability to properly name vari*
consider it a primary responsibility to keep the team involved ables and protect formulas from modification *accidental or and
engaged with a client's culture. otherwise. #fter all, there are certain laws of fluid dynamics
that will never change with regard to line hydraulics as there
Strategy ! - Identify Technical "esources are other constants and calculations that can be placed into
This article considers the challenges of smaller obs, those a controlled environment.
under /4. million. These are the proects where overhead Many of the proect deliverables can be rolled into a com* and
administrative support is cut e!tremely thin. The proect mon database management tool to not only provide a single
manager also may hold a technical design lead role in addition source location of information, but act as a gate check for to
managing the client interface and schedule. shared properties. #s an e!ample, "igure - is a flow path for
"or these type of obs, efficiency in operation is everything. ac9uiring the information regarding the >5 load for a 015 There is
no time to waste on shoving the metrics and tools for 2eturn 5ump. #ssumption is that for this return pump there
/-.. million plus proects down the throat of the team who is is only a tank and line circuit.
not staffed to manage those tools and whereby the larger output This is simplified and meant to demonstrate a linked chain is not
relevant to the smaller proect needs. The team needs of communication and output from three disciplines working tools
that are designed appropriately for smaller, faster paced on a common piece of information. 1f the horsepower changes, obs
with flattened levels of communication throughout. process may have trouble returning the 015 fluid back to the
0ommon challenges that surface on almost all of these skid,e9uipment may have undersi+ed the pump,and electrical
proects are how to manage the proect's technical deliverables may not have accounted for the load. 1nstead of these groups with
the design and procurement of material. :ften a smaller acting in individual bubbles, they are working from a common team
that would include a process engineer, an architect and a technical matri! where each has a part to update and maintain.
proect manager will conceptuali+e the proect with the owner's 1t is not to say that large companies don't communicate well. team.
This results in a rough budget and general plan for More to the point is that on a proect with a small amount of
September/OctOber 2011 PHARMACEUTICAL ENGINEERING !
p
roject management Strategies
"igure -. >5 0alc for 015 return pump.
e9uipment resulting in a smaller electrical scope, there may
not be a budget for a design lead to remain on the proect full
time throughout its duration. This lands the detail in a common
room with links to 9uickly coordinate design impact when proect
changes occur.
,ith a database application such as Microsoft #ccess or :racle
based products,it is common to have a primary interface screen or
"Main Menu." 5roects should be divided by tasks or a minimum
by discipline lead. The separation can be as simple as process,
e9uipment, and electrical. "or each of these primary categories,
subcategories will fall per the deliverables of the proect. 1t may
look like this shown in "igure 6.
1n practice, the main discipline categories will be populated
with many more subcategories, most of which may not be in*
terconnected, but all of which should serve as a data resource area
for the proect team.
B. Technical Design Templates
)omething that works well with one discipline may not be
successful in another, but from a process perspective, design
templates are a must have. ;esign templates are meant to identify
and define boiler plate technical areas that would be repeated
several times through the course of a proect. #s an e!ample,
5&1;s can be split up into many different categories
"igure 6. 1nter*disciplinary proect database flowchart.
# PHARMACEUTICAL ENGINEERING September/OctOber 2011
project management Strategies
such as upstream, downstream, process support e9uipment, utility,
etc. The foundation of these drawings can have sev* eral design
modules in common. # trick brought over from the automation
side is to find groups of valves, instruments, components, or
e9uipment that serve a common function and keep the operation
and representation of those items consis* tent. This allows the
automation team to easily reproduce and troubleshoot areas of their
program that were similar.
"rom the process side,keeping the grouping of small compo*
nents consistent is also an advantage, but branching out into larger
modules of tanks, heat e!changers, and pumps can not only
simplify the entire flow of the 5&1;s, it can help bring
consistency of operation to the finished product. (ow hanging fruit
would be things like vessel temperature control whereby buffer
tanks, media tank, fermentation vessels, product pool tanks, and
other similar vessels can all represent the respec* tive
heating/cooling operation the same way. There may be different
setpoints, but the component cast of characters is often identical.
This also branches out into instrumentation choices. There will be
times when to preserve consistency, a common manufacturer or
instrument model number may be
used even though it is over9ualified for its operation.
5lant steam and process steam traps are another area where
consistency will add a lot of value. 5roducing the design template
for each type of steam system along with the slight variations of
hori+ontal,vertical,and high/low flow trap instal* lations will not
only make it easy for multiple 5&1; owners to have similar
drawings, but the piping designer doing the 0#; work will have a
lot less guess work to do when interpreting markups.
>ere are some other design templates to consider3
conceptual phase serves as the foundation for process e9uip* ment
si+ing,what options are needed,re9uired utility services, and
production support e9uipment. # popular method is to use a
simulator and/or time and motion study to define and document
scale.1t would be good to research whether there are e!isting
industry products out there that may serve the same purpose as an
internal or custom program even if it is done with $!cel
worksheets. # turnkey software product sounds like a good idea<
however, in practice, tends to implement more successfully on
larger obs. These types of tools are often designed for use in
multiple industries and sometimes lack the necessary
customi+ation options to form fit to a smaller work protocol.
# good e!ample is looking at the simulation platforms that are
out there. 2egardless of which platform used, #spen, )uper5ro,
etc., each of them could be manipulated in some way to produce
the desired result or graphic and more often there were very few
people trained to make use of the avail* able customi+ation for
their respective disciplines. 1t some* times results in bringing a
nuclear weapon to a knife fight. By keeping it simple and multi*
use, each discipline lead can create and manage their deliverables
and information on a common database platform with links for
high priority detail throughout. The current versions of software
for #ccess and :racle have very good >TM( options for reporting
whereby weekly updates can be sent automatically through email
or on a secure ,eb site for the whole proect team. This negates the
need for everyone to service the database for common and
fre9uently updated information. This will not take the place of
communication, but will bridge the gap between multiple
disciplines on a small fast*paced ob.
# software platform that is increasingly popular at ob sites
B
B
B
B
media feed through a filter
dual 015 )prayball arrangement for a vessel
shell and tube heat e!changers
chilled water/glycol inlet and outlet valves and instruments
to a room or tank
is that of the fileshare. 5roducts like #utodesk's 0onstruct* ware
and many others profess to provide the kind of seamless
information e!change on a common interface, but can easily morph
into an endless sea of data in an even more endless sea of structured
file folder locations. 0onstructware is no longer
B vent line drip legs manufactured< whether this is due to user problems or a lack B
transfer panel umper design of market demand is debatable. This type of program does B block
and bleed arrangements serve a purpose and is instrumental in the review, distribution,
markup, and archiving of proect documents, but tends to favor
There are more, and the nice thing is that you can make use the construction teams more so than the early design teams. 1t of
these on future proects also.There are differences in design becomes too easy to simply throw a document out there sup*
philosophies around e9uipment, but the basic mechanics will posedly for everyone to have input on only to find out that if remain
constant. collected intranet dust for weeks without moving forward. The
?ote that this is not the same as ust using an old set of proposed database tool in this article will not take the place of
5&1;s, to the contrary, this should protect against inheriting a service like 0onstructware. >owever, it will fill in the need for the
mistakes of previous obs and setting a design standard a fluid design tool interface which serves the discipline lead's for
future proects. calculations and si+ing of e9uipment and components during
the design phases of the proect. The reporting structure of the
C. Simulators and File Share Sot!are database can still be archived in a platform like 0onstructware
:ne of the first considerations on a process driven proect is or a simple proect folder on the intranet.
how best to define scale. ;efining this for the small proect #nother positive aspect of this type of tool is the similar* team is
critical since the schedule is shorter and the need for ity between a typical 5(0/;0) interface and the database
consistency in deliverables is of greater importance. @ive a interface itself. By keeping the database user friendly and
centrifuge design to three different companies and you will implementing push button functions on the main screen and get
three different designs back. ;ocumenting scale in the sub screens, it should serve as familiar territory for anyone
September/OctOber 2011 PHARMACEUTICAL ENGINEERING $
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roject management Strategies
who has run process or utility e9uipment in the field.
1n keeping with the "less is more" aspect of smaller proects, it is
important not to overload your proect database with ancil* lary
functionality that is already done better elsewhere.# good e!ample
of this is smart 5&1;s. 1f properly managed, smart 5&1;s can be
effective in managing the valve, instrument and material lists for
the proect. These lists can be produced from the )mart 5&1;
platform in a database format which can either stand on its own or
sync with your proect database. The advantage of syncing this
data is reducing the chance of double dipping on procurement with
regard to e9uipment boundaries, such as3 where does the shutoff
valves scope lie= 1t also would allow related discipline leads to
append to the information things that may be important to them,
such as unusual power supplies for instrumentation,or special
conduit re9uirements.
Strategy # - ommunication
0ommunications within small proect groups tends to have
both advantages and disadvantages when compared to the larger
teams. The advantages are that it spreads 9uickly and by
companies being small and/or having a small role on the proect,
there is inherent motivation to stay in the loop. )mall proect teams
can push the boundaries of current technology using smart phones
and ,eb based protocols for faster and more seamless interface
with the team.;isadvantages are case dependent, but problems can
arise in the event where team members are remote or perhaps not
full time on the proect. $ngineers with several proects going on at
the same time are often forced to place a pecking order for their
proects to meet their respective deadlines.
This forces the need for a more fre9uent and standing in*
terface between the team. ;uring "#Ts "actory #cceptance Tests
%"#Ts', the small proect scenario plays out in short periods of
time. >ere e!ists the likelihood of team members who are from
different firms and backgrounds, interfacing with a vendor's sub*
team and working remotely sometimes for several weeks. The first
thing a successful "#T team sets up is the schedule and tasks to
complete per the protocol. This may involve starting off with a
daily safety meeting, followed by splitting up to inter*disciplinary
protocol sections, touching base at lunch, and doing a final wrap up
at the end of the day to set the ne!t day's agenda.
"or small proect work, while it does not necessarily have to be
this packed with meetings, the basic theory is sound. More
communication will e9ual better alignment and performance by all
team members. "or the first few weeks of the ob, having a standing
morning meeting for your proect team on site with
telecommunication video capability. 1f people can't attend due to
schedule conflicts, or move the meeting earlier until you can
guarantee attendance, make it mandatory. This helps set the
priorities and allows team members from separate companies to get
to know one another better. )pread out the meetings throughout
the week as deliverables begin to fall into place,but try not to ust
meet once a week. ,ith people uggling travel schedules, remote
operations, and other proect workloads, it won't take much to hit a
conflict. #s a proect manager, don't
fall into the trap of being reactive and calling the fire brigade every
time something goes astray.Things will go wrong. 5ut in a system
of regular,but brief meetings,email/te!t updates,and one*on*ones
with team members to help anticipate problems and respond
accordingly.
0learly communicate the chain of command. 0lients and
consultants alike can tend to break out the corporate org chart and
use this as a guideline for how the proect is going to run. 1f a
person two bars up is never going to be present at the meetings or
play an active daily role on the ob, they should not be listed in the
chain. (et your team have one point of contact for communication
and keep your org chart as flat as possible. This will encourage
doing what needs to be done instead of what team members are
ust supposed to do as a scope or contractual re9uirements.
$ncourage communication by applying incentives to shared
deliverables between different leads within the team. 1ncen* tives
should be built around time spent on the ob to help with mid*
proect defection. ,hen single employees are seconded to a
obsite, they are more at risks for taking the ne!t best thing in ob
opportunity. )traddling a time and milestone type incentive will
help identify the advantageous to sticking with the proect until
completion.
ase Study
>ere is an e!ample of a e!ecuting a ob in a multi*company
proect team. 1n 6..C, Biotech 0ompany # and Biotech 0om* pany
B partnered to produce a Biotech 0ompany # product using
production capacity from one of Biotech 0ompany B's plants. The
proect's engineering company had appro!imately -D process
engineers on site, from two office locations that assumed
responsibility for proect management, process, commissioning
and validation. ,orking side by side were multiple firms,
including a large #&$ firm and several one* person contract
employees selected by Biotech 0ompany B to manage the
engineering and construction side of the proect. Total proect team
si+e between all organi+ations involved was appro!imately 4.
engineers and commissioning staff.
The clients also provided their own proect staff to manage the
technology transfer and to establish continuity in the drug's
manufacture. 0ulturally, there could not be a more different match
up. 0alifornia with ?ew $ngland< large engineering firm with
small<and several one*person -.EEs to fill in the staff where needed<
and nice heavy snowstorm filled winter to be based out of for a
year.,hat appeared disastrous from the onset went very smooth.
)trong client team leaders on both sides kept the staff meetings to a
minimum and utili+ed technology to communicate pertinent
information to the team. $ach client provided an #* team of players
who were intimately familiar with the product and the process and
shared information through a common internet based fileshare
platform. #ll proect staff worked and housed in the same trailers
and many travelled back to their home base every week or every
other week. 5er diems for travel* ers were kept consistent and fair
and non*discriminate based on the company you worked for or
your position. By establish* ing uniform proect directives from the
client's leadership and filtering priorities across all companies on
the ob, a common
% PHARMACEUTICAL ENGINEERING September/OctOber 2011
project management Strategies
focus %flag' was maintained and e!ecuted as a seamless team. 5roect staff
were screened prior to oining the proect for all stated education
credentials through a common background agency that everyone utili+ed.
Teams were purposely divided to include several people from different
companies in each group. This helped to ensure no silos could form and
become cut off from the team or proect communication.
;aily safety meetings and client regimented regular training protocols
provided a platform for continuity among the proect team and eliminated
much of the concerns over intellectual property between competing firms.
)ocial functions were com* mon and designed to be non*e!clusive.
onclusion
The culture of our industry is ever changing and impacts ev*
erything from the latest drug on the market to the way small proects are
e!ecuted with multi*company teams.By thoroughly vetting the proposal
team ahead of time, utili+ing a fle!ible, custom, but powerful tool like an
interdisciplinary database, proect design templates,and a good fileshare
platform,a small, multi*company proect team can be more efficient in
e!ecution and identify problem solutions much sooner in the timeline.
0reating a culture of collaboration to align with proect goals will build
trust amongst the team members and help to retain valuable resources for
longer durations on the ob.
&bout the &uthor
'ar( hristopher 'athis is 2egional Fice
5resident of 1ntegrated 5rocess Technologies, 1nc. and
for the past eight years has managed the )outheast
operations of their $ngineering and )kid "abrication
division. Mathis holds a B) in chemical engineering and
has -E years of e!perience in the pharmaceutical/biotech
industry. >e has performed as both )enior
5roect Manager and )enior 5rocess $ngineer in the design, construction,
and validation of large scale multi*product manufacturing facilities with a
specialty and focus on design of large scale bioreactors and
chromatography systems. Ma* this has designed and 0ommissioned
process e9uipment for a worldwide list of clients. #s a member of 1)5$ for
the past -7 years,he has held several local positions including 0hairperson
of 5rograms and 0ommunications 0ommittees, Treasurer, Fice 5resident
and 5resident of the 0arolina )outh*#tlantic 0hapter. >e currently serves
on the 1)5$ 0#)# Board as 5ast*5resident and 0hairs the 1ndustry
#dvisory 0ouncil for the region. >e also has ust been elected as 0hair of
?#)##0 for 6.-.*6.--. Mathis is blessed with a wonderful marriage
and two boys, 2yan and 0onnor. >e spends his free time fish* ing,
camping, and performing music at local 2aleigh events. >e may be
contacted by telephone3 G-*E-E*784*8.88 or email3
mmathisHintprotech.com.
1ntegrated 5rocess Technologies, 1nc., 4I8 $. 0hatham )t., 0ary, ?orth
0arolina 6D4--, A)#.
September/OctOber 2011 PHARMACEUTICAL ENGINEERING )
doc_180481788.docx
Project management is the discipline of initiating, planning, executing, controlling, and closing the work of a team to achieve specific goals and meet specific success criteria. A project is a temporary endeavor designed to produce a unique product, service or result with a defined beginning and end (usually time-constrained, and often constrained by funding or deliverables) undertaken to meet unique goals and objectives
Reprinted from PHARMACEUTICAL ENGINEERING
®
The Official Magaine of I!PE
!eptem"er#Octo"er $%&&' (ol) *& No) + project management Strategies
,,,)I!PE)org
This article
presents
-Cop.right I!PE $%&&
Pro/ect Management !trategie0 for
m
ethods
and tools for
M1lti2Compan. Pro/ect Team0
successfully
managing
projects
where team
members are
from
multiple
and sometimes
competing
by Mark Mathis
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a
n
i
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t
i
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significantly adding overhead costs. By "cherry
picking" individuals with backgrounds best suited
to the scope, clients can offset the risks of a single
company's shortfalls in personnel.
This scenario does not always provide for a
ceutical/biotech industry have come to enoy
the advantages of assembling proect teams with
e!actly the individuals they need from multiple
sources. There are risks and liabilities that
accompany such decisions, but overall, this helps
keep the market competitive for all service
providers. This shift in resource availability brings
a paradigm shift in how all companies must
e!ecute proects.
"or those who have worked in large and
small#rchitecture and $ngineering %#&$' firm
environments, there is a significant adustment
made when switching between the two. (arger
firms have more established guidelines on how
work is to be performed and by what criteria
specific deliverables are completed. These work
practices can span several industries that the larger
firm services with the idea of creating continuity in
a diverse, more proect fle!ible workforce. )maller
firms have the fle!ibility and freedom to cross
over inter*disciplinary boundaries and by
necessity, must sometimes e!ecute work outside of
their comfort +ones or technical background.
,hat seemed a great divide -. years ago in the
two
operating
philosoph
ies has
now been
pulled
together
to form
the hybrid
proect
team. This
is the
team
where
several
players
from
different
organi+ati
ons are
made to
work
together
to
complete proects as a group. ,hile it does happen
that these hybrids form at the larger /-.. million
plus proects, it is more
lower capital cost for services. To the contrary,
choosing select professionals from multiple firms
will result in the highest Time and Materials
%T&M' rates per person. ,hat is diluted is the need
for e!cessive overhead and administra* tive cost.
0lients with a solid administrative infrastructure
can offset this cost by includ* ing direct personnel
to help with establishing and managing travel
guidelines and e!pense reimbursements. #lso,
integrating members of a client's internal proect
team with the group will result in increased
efficiency in communica* tions and schedule
alignment among all team members.
1n this environment, proects can be derailed by
taking the wrong approach to managing the team
early on. 2isks include larger firms trying to force
their own governing work protocols on everyone
else, individuals acting as lone*wolfs working in
bubbles and not communicating with the group,
and an increased likelihood of defection from key
personnel.Much of this comes down to the
personalities of those involved, but there are
practical and successful strate* gies that if
implemented early on will result in more managed
scope control, higher retention of the core team,
and a significant reduction in encountering the
aforementioned risks along the way.
The concepts address in this article are as
follows3
common to see it at the less than /4. million -. 1dentify Team 5layers
Total 1nstalled 0ost %T10' obs. The rationale is 6. 1dentify the 5roect 0ulture
simple,smaller,more diverse,and focused teams 7. 1dentify Technical 2esources
will bring a wide breadth of e!perience without 8. 0ommunication
September/OctOber 2011 PHARMACEUTICAL ENGINEERING 1
project management Strategies
Strategy 1 - Identify Team Players
$ncountering non*9ualified individuals on proect teams and
reali+ing it a little too late is one of the more common risks all clients try
to avoid. :verstated or embellished resumes can appear from large and
small companies alike.Be on the lookout for inter*corporate nepotism as
well. This can be especially common in proects where large proect
teams are relocated to obsites. 0orporate teams will naturally want to
surround themselves with friends and their own known 9uantities.;on't
assume that educational background was verified and check if the
background seems appropriate for the positions held within the company
or on the proect. There can be managers of engineering staff who do not
have an engineering degree, or other applicable e!perience other than the
relationships with senior staff. 1n some states, you cannot add "engineer"
to a title unless there is a relevant engineering degree and in some cases a
regional license. This is not to say that all positions re9uire degrees, but
be discriminating with relocating proect teams. The #&$'s goal is to
provide the right person, but often has to choose from a shallow pool of
those employees who are willing to relocate. )et a proect standard for
background checks and degree verifications for everyone regardless of
affiliation.This helps minimi+e what has become known as "empire
building" on proects where the priorities tend to shift away from the
proect and more toward the individuals involved.
#nother risk common in this scenario is personnel hired solely for the
purpose of relocating. 1f you are considering a contract with any firm that
includes relocating staff,you should e!pect personnel that are e!perienced
with that company's policies and loyal to representing them even when
away from the corporate home front. # senior e!ecutive brought on to
pad a ob with years and years of e!perience but no ties to the
organi+ation and a history of umping companies can 9uickly poison
the well for other members of the team. This too can turn into empire
building which will only serve the goals of the empire and not the
proect.
)maller firms will have every motivation to put their best face
forward, but may not reali+e the advantages of integrat* ing with others.
1t is easy to default to posturing and e!ag* geration of capabilities
instead of identifying areas where they need support from others. Be
aware of those that would propose to hold any technical role on a
proect. # small firm or individual should be fle!ible, but should have
some area of e!pertise and a willingness to shore up the places where
they are not as e!perienced. 1n fact, this is the primary advantage of
assembling a team from multiple organi+ations.
There should be one flag for any proect team. )ince team members
may originate from several different entities,a single governing set of
directives that is aligned with the proect obectives should be in place
and managed by the team leader. 1f possible, become familiar with
what the internal goals or employee incentives that may be in place at
the different firms. Make sure these will align with proect
e!pectations. There are several technical strategies to defining the way
a proect will be e!ecuted but first, the hard part< identifying the proect
team's culture.
Strategy 2 - Identify the Project ulture
,hat is it about our industry that remains constant regardless
of the company you work for or the products you help produce= 1t is the
culture of that organi+ation that defines, enhances, or limits the ability of
the group to achieve success. There are many uni9ue characteristics of the
pharmaceutical, and more specifically,the biotech arena that set it apart
from other multi* billion dollar industries. :ne that stands out is the fact
that biotech itself is still an ever e!panding and new marketplace. >aving
not been around near as long as the food and beverage, polymer,
semiconductor and a host of other similar product driven groups< biotech
has 9uickly set the pace of continually redefining itself every few years.
$!isting drug products are being manufactured more efficiently and
becoming safer to produce and consume< and new drugs are pushing the
enve* lope of what manufacturing and design tools are out there to
formulate the product and increase speed to market.
1f a hierarchy of culture were assembled for the biotech industry, it
would include the fact that our media age con* tinues to be one of the
youngest, second only to $commerce< our workers and service providers
can 9uickly set themselves apart as generators of new ideas and specialists
in new areas of e!pertise< that the very core products are themselves a gen*
erous payback to those that work in the industry, striving to better the
9uality of life for friends, families and in most cases strangers around the
globe. ,hen speaking to those still in school, this culture is the easiest to
convey because there are ust a few professions that are as e!citing and
fulfilling as the pharmaceutical/biotech industry. ?o student can resist
even the very basic principles of @"5s @reen "luorescent 5rotein %@"5s'
and watching mice and other mammals glow under a black light.
0ombine that and other e!citing technological advancements with the
fulfillment of serving the sick and reducing the spread of disease
worldwide, and you have an interested and engaged pupil.
Anderneath the culture of the industry resides the culture of the
individual company. This can be a manufacturer, a con* sulting group, or
any number of service providers that work in the field. The first maor
challenge of working with a new client is determining what their culture
is. This is more than a mission statement, it defines their community and
ultimately what their priorities are. There are vast differences between
company cultures that become evident after spending time with many of
the larger drug makers. There are regional in* fluences in west and east
coast businesses and depending on the drugs produced< there are
differences in attitudes about manufacturing< there are campuses that
resemble colleges and parties and events that would impress even the
coolest "acebook employee. ,orking at an acetaminophen plant will
highlight the e!treme difference between making aspirin additives in
large bulk 9uantities and making a drug that only applies to a select
market of consumers. The employees, the packaging, and very processes
are all very distinct to the culture of the company where the drug is
made.
The reason all of this becomes important to consider as part of aTeam
(eadership paradigm is that the culture of operations e!tend throughout
all uni9ue companies, but none is more
2 PHARMACEUTICAL ENGINEERING September/OctOber 2011
project management Strategies
challenging and ever changing than that of the small business facility and e9uipment. Material and personnel flows, s9uare
consultant. (arger engineering firms that service multiple footage and throughput are critical to establish and set the
industries where biotech is but a small sector, cannot afford groundwork for the preliminary and detailed design teams to
greatly deviate the process by which they e!ecute proects. to gather information for their respective disciplines. ,here #n
engineer or manager working in the biotech sector one day large groups of engineers maintain a respectable catalogue may be
working in the petroleum group the ne!t, especially of past proects, computer programs, and other resources to those
who work on the infrastructure or non*process driven draw from, it may be cost prohibitive for a client to bring them side.
>owever, the smaller companies, specifically those that on board, or more likely, teams are now cherry picked from a
choose to focus on the pharmaceutical/biotech industry alone, variety of organi+ations where issues of intellectual property must
constantly reevaluate the respective client's culture with prohibits an open and sharing environment. 1n the absence of every
proect. This is a more intimate environment where more traditional resources,coming up with uni9ue proect tools
more often than not, consultants are brought into the fold of for the team can be challenging. These tools need to not only a
clients operating group. $ven going so far as to integrate streamline the more mechanical operations %like datasheet and them
into site specific training, access to facilities and perks, specification assembly', but make communication of technical
and internal metrics by which performance is rated along side and commercial data more efficient.
of full time employees. The relative cost of failure was mentioned in one of this
)o in this rapidly changing environment, how does a small year's earlier articles on risk assessment and also has great
company navigate the different modes of operation within a relevance for this topic. The primary goal of a proect team
changing client roster, while simultaneously establishing a is not to e!ecute perfectly, but to properly evaluate risk and uni9ue
identity in this environment= )omething that becomes identify problems as early in the proect as possible, knowing
apparent when an engineer leaves the fold of a big company, is that failure costs increase e!ponentially with time.
that the workload and responsibility matrices begin to flatten.
The lines of segregating interdisciplinary tasks and obectives A. Multi-User Project Database
are no longer clearly marked. # process engineer must now "or process engineers who must now manage e9uipment, a
understand e9uipment and procurement< a mechanical de* customi+ed database application can be a good place to start.
sign engineer must now route pipe and duct alike< a controls The days of $!cel's large, multi*layer worksheets with count*
engineer has to step outside of the programming bubble to less embedded calculations referencing obscure and sometimes
consider people and material flow and locate shared, multi* hidden cell locations are phasing out. #s these programs are
purpose operator interface stations or :1Ts. passed on or reused, they can't help but bring the old proect
1dentifying and understanding the client's culture is a key problems into the new proect. Too often there is only a single
first step in any team's success. 1t is e9ually the responsibility individual who may no longer be with the organi+ation that
of the client to communicate this to the group, understanding even knows the details of the programs design, fudge factors,
that those not in the fold may not be aware of what happens or macros. ,hile creating a database management system
behind the scenes. The leadership of the team should take an does come with its own set of challenges and frustrations, a
active part in making sure everything is communicated and very powerful advantage is the ability to properly name vari*
consider it a primary responsibility to keep the team involved ables and protect formulas from modification *accidental or and
engaged with a client's culture. otherwise. #fter all, there are certain laws of fluid dynamics
that will never change with regard to line hydraulics as there
Strategy ! - Identify Technical "esources are other constants and calculations that can be placed into
This article considers the challenges of smaller obs, those a controlled environment.
under /4. million. These are the proects where overhead Many of the proect deliverables can be rolled into a com* and
administrative support is cut e!tremely thin. The proect mon database management tool to not only provide a single
manager also may hold a technical design lead role in addition source location of information, but act as a gate check for to
managing the client interface and schedule. shared properties. #s an e!ample, "igure - is a flow path for
"or these type of obs, efficiency in operation is everything. ac9uiring the information regarding the >5 load for a 015 There is
no time to waste on shoving the metrics and tools for 2eturn 5ump. #ssumption is that for this return pump there
/-.. million plus proects down the throat of the team who is is only a tank and line circuit.
not staffed to manage those tools and whereby the larger output This is simplified and meant to demonstrate a linked chain is not
relevant to the smaller proect needs. The team needs of communication and output from three disciplines working tools
that are designed appropriately for smaller, faster paced on a common piece of information. 1f the horsepower changes, obs
with flattened levels of communication throughout. process may have trouble returning the 015 fluid back to the
0ommon challenges that surface on almost all of these skid,e9uipment may have undersi+ed the pump,and electrical
proects are how to manage the proect's technical deliverables may not have accounted for the load. 1nstead of these groups with
the design and procurement of material. :ften a smaller acting in individual bubbles, they are working from a common team
that would include a process engineer, an architect and a technical matri! where each has a part to update and maintain.
proect manager will conceptuali+e the proect with the owner's 1t is not to say that large companies don't communicate well. team.
This results in a rough budget and general plan for More to the point is that on a proect with a small amount of
September/OctOber 2011 PHARMACEUTICAL ENGINEERING !
p
roject management Strategies
"igure -. >5 0alc for 015 return pump.
e9uipment resulting in a smaller electrical scope, there may
not be a budget for a design lead to remain on the proect full
time throughout its duration. This lands the detail in a common
room with links to 9uickly coordinate design impact when proect
changes occur.
,ith a database application such as Microsoft #ccess or :racle
based products,it is common to have a primary interface screen or
"Main Menu." 5roects should be divided by tasks or a minimum
by discipline lead. The separation can be as simple as process,
e9uipment, and electrical. "or each of these primary categories,
subcategories will fall per the deliverables of the proect. 1t may
look like this shown in "igure 6.
1n practice, the main discipline categories will be populated
with many more subcategories, most of which may not be in*
terconnected, but all of which should serve as a data resource area
for the proect team.
B. Technical Design Templates
)omething that works well with one discipline may not be
successful in another, but from a process perspective, design
templates are a must have. ;esign templates are meant to identify
and define boiler plate technical areas that would be repeated
several times through the course of a proect. #s an e!ample,
5&1;s can be split up into many different categories
"igure 6. 1nter*disciplinary proect database flowchart.
# PHARMACEUTICAL ENGINEERING September/OctOber 2011
project management Strategies
such as upstream, downstream, process support e9uipment, utility,
etc. The foundation of these drawings can have sev* eral design
modules in common. # trick brought over from the automation
side is to find groups of valves, instruments, components, or
e9uipment that serve a common function and keep the operation
and representation of those items consis* tent. This allows the
automation team to easily reproduce and troubleshoot areas of their
program that were similar.
"rom the process side,keeping the grouping of small compo*
nents consistent is also an advantage, but branching out into larger
modules of tanks, heat e!changers, and pumps can not only
simplify the entire flow of the 5&1;s, it can help bring
consistency of operation to the finished product. (ow hanging fruit
would be things like vessel temperature control whereby buffer
tanks, media tank, fermentation vessels, product pool tanks, and
other similar vessels can all represent the respec* tive
heating/cooling operation the same way. There may be different
setpoints, but the component cast of characters is often identical.
This also branches out into instrumentation choices. There will be
times when to preserve consistency, a common manufacturer or
instrument model number may be
used even though it is over9ualified for its operation.
5lant steam and process steam traps are another area where
consistency will add a lot of value. 5roducing the design template
for each type of steam system along with the slight variations of
hori+ontal,vertical,and high/low flow trap instal* lations will not
only make it easy for multiple 5&1; owners to have similar
drawings, but the piping designer doing the 0#; work will have a
lot less guess work to do when interpreting markups.
>ere are some other design templates to consider3
conceptual phase serves as the foundation for process e9uip* ment
si+ing,what options are needed,re9uired utility services, and
production support e9uipment. # popular method is to use a
simulator and/or time and motion study to define and document
scale.1t would be good to research whether there are e!isting
industry products out there that may serve the same purpose as an
internal or custom program even if it is done with $!cel
worksheets. # turnkey software product sounds like a good idea<
however, in practice, tends to implement more successfully on
larger obs. These types of tools are often designed for use in
multiple industries and sometimes lack the necessary
customi+ation options to form fit to a smaller work protocol.
# good e!ample is looking at the simulation platforms that are
out there. 2egardless of which platform used, #spen, )uper5ro,
etc., each of them could be manipulated in some way to produce
the desired result or graphic and more often there were very few
people trained to make use of the avail* able customi+ation for
their respective disciplines. 1t some* times results in bringing a
nuclear weapon to a knife fight. By keeping it simple and multi*
use, each discipline lead can create and manage their deliverables
and information on a common database platform with links for
high priority detail throughout. The current versions of software
for #ccess and :racle have very good >TM( options for reporting
whereby weekly updates can be sent automatically through email
or on a secure ,eb site for the whole proect team. This negates the
need for everyone to service the database for common and
fre9uently updated information. This will not take the place of
communication, but will bridge the gap between multiple
disciplines on a small fast*paced ob.
# software platform that is increasingly popular at ob sites
B
B
B
B
media feed through a filter
dual 015 )prayball arrangement for a vessel
shell and tube heat e!changers
chilled water/glycol inlet and outlet valves and instruments
to a room or tank
is that of the fileshare. 5roducts like #utodesk's 0onstruct* ware
and many others profess to provide the kind of seamless
information e!change on a common interface, but can easily morph
into an endless sea of data in an even more endless sea of structured
file folder locations. 0onstructware is no longer
B vent line drip legs manufactured< whether this is due to user problems or a lack B
transfer panel umper design of market demand is debatable. This type of program does B block
and bleed arrangements serve a purpose and is instrumental in the review, distribution,
markup, and archiving of proect documents, but tends to favor
There are more, and the nice thing is that you can make use the construction teams more so than the early design teams. 1t of
these on future proects also.There are differences in design becomes too easy to simply throw a document out there sup*
philosophies around e9uipment, but the basic mechanics will posedly for everyone to have input on only to find out that if remain
constant. collected intranet dust for weeks without moving forward. The
?ote that this is not the same as ust using an old set of proposed database tool in this article will not take the place of
5&1;s, to the contrary, this should protect against inheriting a service like 0onstructware. >owever, it will fill in the need for the
mistakes of previous obs and setting a design standard a fluid design tool interface which serves the discipline lead's for
future proects. calculations and si+ing of e9uipment and components during
the design phases of the proect. The reporting structure of the
C. Simulators and File Share Sot!are database can still be archived in a platform like 0onstructware
:ne of the first considerations on a process driven proect is or a simple proect folder on the intranet.
how best to define scale. ;efining this for the small proect #nother positive aspect of this type of tool is the similar* team is
critical since the schedule is shorter and the need for ity between a typical 5(0/;0) interface and the database
consistency in deliverables is of greater importance. @ive a interface itself. By keeping the database user friendly and
centrifuge design to three different companies and you will implementing push button functions on the main screen and get
three different designs back. ;ocumenting scale in the sub screens, it should serve as familiar territory for anyone
September/OctOber 2011 PHARMACEUTICAL ENGINEERING $
p
roject management Strategies
who has run process or utility e9uipment in the field.
1n keeping with the "less is more" aspect of smaller proects, it is
important not to overload your proect database with ancil* lary
functionality that is already done better elsewhere.# good e!ample
of this is smart 5&1;s. 1f properly managed, smart 5&1;s can be
effective in managing the valve, instrument and material lists for
the proect. These lists can be produced from the )mart 5&1;
platform in a database format which can either stand on its own or
sync with your proect database. The advantage of syncing this
data is reducing the chance of double dipping on procurement with
regard to e9uipment boundaries, such as3 where does the shutoff
valves scope lie= 1t also would allow related discipline leads to
append to the information things that may be important to them,
such as unusual power supplies for instrumentation,or special
conduit re9uirements.
Strategy # - ommunication
0ommunications within small proect groups tends to have
both advantages and disadvantages when compared to the larger
teams. The advantages are that it spreads 9uickly and by
companies being small and/or having a small role on the proect,
there is inherent motivation to stay in the loop. )mall proect teams
can push the boundaries of current technology using smart phones
and ,eb based protocols for faster and more seamless interface
with the team.;isadvantages are case dependent, but problems can
arise in the event where team members are remote or perhaps not
full time on the proect. $ngineers with several proects going on at
the same time are often forced to place a pecking order for their
proects to meet their respective deadlines.
This forces the need for a more fre9uent and standing in*
terface between the team. ;uring "#Ts "actory #cceptance Tests
%"#Ts', the small proect scenario plays out in short periods of
time. >ere e!ists the likelihood of team members who are from
different firms and backgrounds, interfacing with a vendor's sub*
team and working remotely sometimes for several weeks. The first
thing a successful "#T team sets up is the schedule and tasks to
complete per the protocol. This may involve starting off with a
daily safety meeting, followed by splitting up to inter*disciplinary
protocol sections, touching base at lunch, and doing a final wrap up
at the end of the day to set the ne!t day's agenda.
"or small proect work, while it does not necessarily have to be
this packed with meetings, the basic theory is sound. More
communication will e9ual better alignment and performance by all
team members. "or the first few weeks of the ob, having a standing
morning meeting for your proect team on site with
telecommunication video capability. 1f people can't attend due to
schedule conflicts, or move the meeting earlier until you can
guarantee attendance, make it mandatory. This helps set the
priorities and allows team members from separate companies to get
to know one another better. )pread out the meetings throughout
the week as deliverables begin to fall into place,but try not to ust
meet once a week. ,ith people uggling travel schedules, remote
operations, and other proect workloads, it won't take much to hit a
conflict. #s a proect manager, don't
fall into the trap of being reactive and calling the fire brigade every
time something goes astray.Things will go wrong. 5ut in a system
of regular,but brief meetings,email/te!t updates,and one*on*ones
with team members to help anticipate problems and respond
accordingly.
0learly communicate the chain of command. 0lients and
consultants alike can tend to break out the corporate org chart and
use this as a guideline for how the proect is going to run. 1f a
person two bars up is never going to be present at the meetings or
play an active daily role on the ob, they should not be listed in the
chain. (et your team have one point of contact for communication
and keep your org chart as flat as possible. This will encourage
doing what needs to be done instead of what team members are
ust supposed to do as a scope or contractual re9uirements.
$ncourage communication by applying incentives to shared
deliverables between different leads within the team. 1ncen* tives
should be built around time spent on the ob to help with mid*
proect defection. ,hen single employees are seconded to a
obsite, they are more at risks for taking the ne!t best thing in ob
opportunity. )traddling a time and milestone type incentive will
help identify the advantageous to sticking with the proect until
completion.
ase Study
>ere is an e!ample of a e!ecuting a ob in a multi*company
proect team. 1n 6..C, Biotech 0ompany # and Biotech 0om* pany
B partnered to produce a Biotech 0ompany # product using
production capacity from one of Biotech 0ompany B's plants. The
proect's engineering company had appro!imately -D process
engineers on site, from two office locations that assumed
responsibility for proect management, process, commissioning
and validation. ,orking side by side were multiple firms,
including a large #&$ firm and several one* person contract
employees selected by Biotech 0ompany B to manage the
engineering and construction side of the proect. Total proect team
si+e between all organi+ations involved was appro!imately 4.
engineers and commissioning staff.
The clients also provided their own proect staff to manage the
technology transfer and to establish continuity in the drug's
manufacture. 0ulturally, there could not be a more different match
up. 0alifornia with ?ew $ngland< large engineering firm with
small<and several one*person -.EEs to fill in the staff where needed<
and nice heavy snowstorm filled winter to be based out of for a
year.,hat appeared disastrous from the onset went very smooth.
)trong client team leaders on both sides kept the staff meetings to a
minimum and utili+ed technology to communicate pertinent
information to the team. $ach client provided an #* team of players
who were intimately familiar with the product and the process and
shared information through a common internet based fileshare
platform. #ll proect staff worked and housed in the same trailers
and many travelled back to their home base every week or every
other week. 5er diems for travel* ers were kept consistent and fair
and non*discriminate based on the company you worked for or
your position. By establish* ing uniform proect directives from the
client's leadership and filtering priorities across all companies on
the ob, a common
% PHARMACEUTICAL ENGINEERING September/OctOber 2011
project management Strategies
focus %flag' was maintained and e!ecuted as a seamless team. 5roect staff
were screened prior to oining the proect for all stated education
credentials through a common background agency that everyone utili+ed.
Teams were purposely divided to include several people from different
companies in each group. This helped to ensure no silos could form and
become cut off from the team or proect communication.
;aily safety meetings and client regimented regular training protocols
provided a platform for continuity among the proect team and eliminated
much of the concerns over intellectual property between competing firms.
)ocial functions were com* mon and designed to be non*e!clusive.
onclusion
The culture of our industry is ever changing and impacts ev*
erything from the latest drug on the market to the way small proects are
e!ecuted with multi*company teams.By thoroughly vetting the proposal
team ahead of time, utili+ing a fle!ible, custom, but powerful tool like an
interdisciplinary database, proect design templates,and a good fileshare
platform,a small, multi*company proect team can be more efficient in
e!ecution and identify problem solutions much sooner in the timeline.
0reating a culture of collaboration to align with proect goals will build
trust amongst the team members and help to retain valuable resources for
longer durations on the ob.
&bout the &uthor
'ar( hristopher 'athis is 2egional Fice
5resident of 1ntegrated 5rocess Technologies, 1nc. and
for the past eight years has managed the )outheast
operations of their $ngineering and )kid "abrication
division. Mathis holds a B) in chemical engineering and
has -E years of e!perience in the pharmaceutical/biotech
industry. >e has performed as both )enior
5roect Manager and )enior 5rocess $ngineer in the design, construction,
and validation of large scale multi*product manufacturing facilities with a
specialty and focus on design of large scale bioreactors and
chromatography systems. Ma* this has designed and 0ommissioned
process e9uipment for a worldwide list of clients. #s a member of 1)5$ for
the past -7 years,he has held several local positions including 0hairperson
of 5rograms and 0ommunications 0ommittees, Treasurer, Fice 5resident
and 5resident of the 0arolina )outh*#tlantic 0hapter. >e currently serves
on the 1)5$ 0#)# Board as 5ast*5resident and 0hairs the 1ndustry
#dvisory 0ouncil for the region. >e also has ust been elected as 0hair of
?#)##0 for 6.-.*6.--. Mathis is blessed with a wonderful marriage
and two boys, 2yan and 0onnor. >e spends his free time fish* ing,
camping, and performing music at local 2aleigh events. >e may be
contacted by telephone3 G-*E-E*784*8.88 or email3
mmathisHintprotech.com.
1ntegrated 5rocess Technologies, 1nc., 4I8 $. 0hatham )t., 0ary, ?orth
0arolina 6D4--, A)#.
September/OctOber 2011 PHARMACEUTICAL ENGINEERING )
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