Dear business partner In this issue

Walter Kittl
– our American All-Rounder
became General Manager of Siegfried (USA) in Pennsville, NJ and he is
full of praise for the country and the
people there: the sense of freedom and
openness – both geographically and
with people – have charmed the Kittls.
Neither has regretted the transatlantic
move for a moment.
Walter Kittl has such
diverse interests – at
work and at home – that
trying to describe all of
them would go way beyond the space available
in our newsletter.
Walter grew up in Austria, on a farm
in the picturesque Salzburg region. He
enjoyed boarding school, where he received a comprehensive education that
included ancient Greek. In addition to
schoolwork there was time for his passions: sports, music and theater. Later,
he studied Chemistry at the University
of Innsbruck and found his first job –
like many of his college classmates
– at the Chemie Linz Company. But
Corporate News 3/09
Dear business partner
The topic of compliance has gained
added importance with to the policies
of Margret A. Hamburg, the new FDA
Commissioner. Recent events (Heparin,
falsification of documents, etc.) have
led to a massive increase in the number
of audits and reviews; the number of
Warning Letters has quadrupled.
Siegfried Pennsville and our customers
have also benefited from Walter’s commitment to his work. Not only is he
an all-rounder, but also a strong team
player and manager that leads and motivates – every day. Our customers are
enthusiastic about the support they get
from Siegfried, and keep coming back.
it soon became clear to Walter that
chemistry alone was not going to ‘cut
it’ and he decided to branch out with a
degree in Process Engineering from the
University Graz and in Management
from the renowned Professor Malik at
the Management Zentrum St. Gallen
in Switzerland. He also added IT to his
areas of interest, focusing on process
simulation and production control. It
wasn’t long before he had developed
an innovative production planning tool
for Chemie Linz.
Walter’s restless energy led him to
Roche in Basel, Switzerland, where he
managed the Chemical Production,
and then to Siegfried. A key reason for
his move to Siegfried was the possibility to work in the U.S.A. – a dream
destination for both Walter and his
wife Andrea. About two years ago he
Walter and Andrea, a pharmacist, live
in Delaware. Their children are already
grown-up and study in Switzerland.
The kids enjoy visiting the parents in
the U.S. and Andrea checks up on
them and their house in Basel, where
they live, with frequent trips to Switzerland.
Traveling in the U.S.A. and exploring
the national parks are a favorite pastime for Walter and Andrea. Long hikes
provide valuable time together and get
them away from work. Walter likes
playing chess – if there is time – and he
has also rediscovered a favorite hobby
from his youth: target shooting. We
are confident that he will be holding
up trophies for marksmanship soon.
For Siegfried, he’s hit the bull’s-eye
consistently for a long time.
In this issue
Corporate News 3/09
• Success Factor
Professional Project Management
Dr. Hubert Stückler,
President
Siegfried Actives Division
In this issue we take a closer look at
the topic of ‘compliance,’ in particular
what it means to prepare and carry out
a customer audit.
Fundamentally, we believe a customer
audit should benefit both the customer
and the supplier. The customer wants
a general overview of Siegfried and/or
of the project/product status. We want
to better understand the needs of the
customer and show that we recognize
the importance of compliance issues.
In other words, an audit should enable
an exchange of information and create
value.
This shows how a reliable compliance
process can be a key success factor.
Neither you nor Siegfried is willing to
compromise in compliance matters that
could put our projects/products at risk.
This is why, for many of our customers,
Siegfried remains the preferred compliance partner.
As one of the few companies in our
market with extensive experience in development support and production in
both the primary and secondary areas,
Siegfried intends to increasingly offer
this unique capability to more of our
customers. The necessary adaptations
to our internal processes, especially in
project management, are now being implemented. We will keep you
informed about this offer.
• Siegfried’s strategy and USP
• Portrait
Corporate Know-how 3/09 • Customer Audits
Obligation or Opportunity for a
Trusting Relationship?
Siegfried Symposium 2010
September 23rd 2010 at the
We look forward to continuing and
expanding our partnership during the
coming year and wish you and your
family a Happy New Year.
Kongresshaus Zurich
Please reserve this date
Siegfried’s strategy
Siegfried has a clear commitment to custom
manufacturing
Siegfried benefits from synergies between the
different skills in the company (API, dosage forms)
Siegfried offers advanced formulations for innovators
and other customers in the life science environment
Siegfried’s USP
Primär
Axel Heuser
Success Factor: Professional
Project Management at Siegfried
Today, all our customers – small
start-ups and big pharma houses
alike – expect an increasingly
shorter “time to market” for any
new drug candidate. Accelerated
development leads to closely scrutinized timelines, which puts extreme
pressure on the development teams.
Shorter time to market leaves little
room for delays, not to mention any
sort of failure. A reliable outsource
partner must ensure on-time delivery – with high quality results and
minimal project risks. Obviously,
this demands a high degree of flexibility and the ability to resolve any
issues quickly and efficiently.
Adding dedicated project
managers
To best meet these increasingly
stringent customer expectations,
Siegfried has professionalized its
project management over the past
Anders Sjöberg
Stephan Amrein
few years. Our entire organization has
been transformed from a hierarchic to
a matrix-oriented structure to ensure
more flexibility and shorter communication pathways. Currently, Siegfried has
four experienced project managers at
our headquarters in Zofingen, Switzerland, and one project manager at our
U.S. facility in Pennsville, NJ. These experts manage the development projects
for our customers. The Siegfried project
manager is involved right from the
beginning: during the evaluation of a
potential new project. Once the project
is approved, the project manager assembles a cross-functional project team
that corresponds to the scope of the
project. Usually, the core project team
consists of a chemical project leader, an
analytical project leader, a scale-up and/
or production chemist, a QA manager
and a production engineer. Further
experts from strategic raw material
sourcing, Environment, Health & Safety
(EHS), Regulatory Affairs, Accounting
and Customer Service are involved as
needed.
Frieder Mitzel
Wide range of responsibilities
A kick-off meeting starts the project;
the project manager reviews scope,
timelines and budget with the project
team and line management. During the
execution phase, the responsibilities of
the project manager are diverse: control
progress versus timelines and budget,
ensure that the project team is on track,
adjust to unexpected events, and keep
stakeholders informed. The ultimate
goal is to make sure the project is completed – and delivered – on time.
But that’s not all. The project manager
is also the primary customer contact
for all technical aspects of the project.
Together with Marketing & Sales, the
project manager must maintain an
appropriate level of communication
between the project team and the
customer, and facilitate the dialogue
between the experts of both teams.
Usually, this means carrying out regular
telephone conferences and/or providing
regular project status reports.
Chemische
ProzessEntwicklung
Jennifer Goodall
Adding value for our customers
Because a typical API development
project has multiple project phases,
the project team remains in charge
until all phases are completed; this is
usually until the successful commercial scale process validation. After
the validation, the project team
transfers responsibility to a Commercial Product Leadership Team
to guarantee continuity with the
customer.
By implementing a highly professional level of project management
at Siegfried, we have enhanced our
performance and can now offer
solutions specifically tailored to the
demands of our customers – with
increased speed, reliability and flexibility. Our project managers add
significant value to our customer’s
development programs.
Dr. Frieder Mitzel
Project Manager Actives
Pharmazeutische
EntwicklungsLeistungen
Chemische
Produktion
Pharmazeutische
Produktion
Sekundär
Siegfried’s future is built on traditional key strengths
benefiting from a history of over 130 years
Siegfried has skills and track record in both, primary
(API) and secondary (dosage form) manufacturing
Impressum
Behind the Scenes Issue 3/09 © 2009
For a PDF version: www.siegfried.ch
Siegfried Ltd
Comments are welcome.
Untere Brühlstrasse 4
Please send any input concerning
CH-4800 Zofingen / Switzerland
“Behind the Scenes” to
Phone +41 62 746 11 11
[email protected]
Editor: Hubert Stückler