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_____brett l. schmidli

BRETT L. SCHMIDLI

INDUSTRIAL EXPERIENCE
Beckman Coulter, Inc.

Vice President, Discovery & Lab Automation Supply Chain Management

8/09 to Present

Vice President, Immunoassay Manufacturing Operations

6/07 to 8/09

I lead the High Sensitivity Testing (HST) Group supply chains for our Immunoassay, Manual
Immunoassay, and Molecular Diagnostics businesses. This includes direct responsibility for the supply
chain operations in Chaska, MN and Webster, TX (about 450 people and an annual operating budget of
~$160 million). The primary groups included in our supply chain organization, for each of the businesses
mentioned above, are: 1) Sourcing, Supplier & Partner Relationship Management, and Procurement;
2) Production and Product Planning; 3) Technical Operations and Process Engineering; 4) Instrument
Manufacturing; 5) Reagent and Consumables Manufacturing; and 6) Site Services (Facilities, Utilities,
Maintenance, Administrative Services, Document Control, and Technical Publications).
Over the past three years, we have had success in implementing Lean Six Sigma across our entire supply
chain operations, resulting in significant, sustainable improvements in our business processes, product
flow, cycle times, space utilization, productivity, and product costs. Our Immunoassay Instrument
Manufacturing has been awarded the 2007 Beckman-Coulter Lean Six Sigma Award, and has been
recognized as the 2008 Minnesota Manufacturer of the Year by the Minnesota Manufacturers Alliance.

Consultant
General Consultant, Pharmaceuticals and Biopharmaceuticals
1/06 to 6/07

Consulted broadly in both strategic and tactical areas within Technical Operations (Development,
Engineering, Manufacturing, Quality, and Compliance) in the Pharmaceutical and Bipharmaceutical
Industry. Provided consulting support to Cardiome, West Coast Biologics, and PDL BioPharma (my
primary consulting client). Was the CMC Team Leader for the Ularitide Project at PDL. Ularitide was a
synthetic naturetic peptide starting Phase 3 clinical development for the treatment of acute decompensated
heart failure.

PDL BioPharma (Formerly Protein Design Labs, Inc.)
Senior VP, Technical Operations and GM, Manufacturing Sites
2/02 to 12/05
Responsible for the overall Technical Operations at Protein Design Labs (PDL), encompassing the Technical Development, Engineering, Manufacturing, and Quality & Compliance organizations, operating in both Fremont, CA and Plymouth and Brooklyn Park, MN. This included approximately 300 of the company‟s worldwide staffing of 750 employees, growing at a rate of more than 25% per year. During this time, PDL was a leader in the discovery, development, and manufacturing of humanized monoclonal antibodies, and other biologics, intended for the treatment of various cancers, autoimmune disorders, and acute heart failure, with four products (three monoclonal antibodies and a synthetic peptide) in late stage clinical development. The groups that I built and led at PDL were responsible for; 1) developing the processes, product forms, and analytical methodology by which the products are manufactured and controlled, 2) designing, constructing, and qualifying facilities for the development and manufacture of the
antibody products, 3) validating the manufacturing processes, 4) manufacturing the antibody products for
both clinical and commercial use, and 5) ensuring the quality of the products and the regulatory compliance
of the manufacturing operations.

Eli Lilly and Company

Director of Manufacturing Strategy, Global Manufacturing & Supply Services
11/00 to 1/02
Responsible for the business processes of strategy development and governance for the global
manufacturing organization. Led projects in the areas of competitive analysis, long range planning, product
sourcing, manufacturing capacity planning, knowledge management, and the design/implementation of
many of the Lilly Manufacturing governance structures/processes. Reported to the Vice President of
Global Manufacturing (a global organization of about 11,000 employees). Was involved in, and in some
cases led, corporate level strategic issues planning teams.
Chief Operating Officer, New Antidepressant Team
4/00 to 11/00
I led the operational activities of the New Antidepressant Team (a team of about 100 dedicated, co-located individuals and about 400 part-time, cross-functional individuals). This included direct responsibility for the pharmaceutical project management, development project management, submission team, and launch team groups for both of our potential new antidepressants in late stage development (about 50% of the total staff). I provided leadership in the overall development of these antidepressant assets as the chair of both of the New Antidepressant Product Core Teams. Through aggressive planning and implementation we were able to accelerate the overall development timelines (to submission) for each of these leading candidate molecules by more than 12 months. One of these two new antidepressant candidates, Cymbalta, received FDA regulatory approval, and is approved for patients suffering from depression and anxiety, including physical pain symptoms. It is now one of Eli Lilly‟s most important products. During my tenure as a leader of the overall development efforts for our new antidepressants, I dramatically expanded my knowledge of the clinical and commercial aspects of bringing new pharmaceutical products to the market. Director of Operations and Commercial Development, New Antidepressants
7/98 to 4/00

I co-led the new antidepressant development effort. Our team was responsible for the development of a
small portfolio of new antidepressants (all potential successor products to Prozac). We organized, staffed,
and led this highly visible, very high priority team. For me, this included primary responsibility for the
project management, business development and licensing, market planning, market research, process
development, product development, and manufacturing functions within the team. Our team was very
successful in driving the licensing (where necessary) and aggressive commercial development of several
potential new antidepressant assets.
In 4/00, this team achieved a positive product decision for the first of our antidepressant assets and became
formally commissioned as a Product Team (the New Antidepressant Team). This led to my change in title
(to COO) and my expanded responsibilities (as shown above).
Director of Marketing, Prozac New Ventures and Antidepressant Strategy
2/98 to 7/98

I was co-leader of the Future Business Initiatives sub-team for the Prozac Product Team. This sub-team
was responsible for all Prozac line extensions, new indications for Prozac, and the selection and early
development of potential new antidepressants (successor products to Prozac). This assignment included
my leadership of the US Prozac Late Lifecycle/Post Patent Planning Team. In addition, I was a key
member of the Corporate Year X (Prozac Patent Expiry) Strategy Committee.
Director of Product Development and Manufacturing,
Neuroscience Business Unit

4/95 to 2/98

I was responsible for planning and coordinating product development and manufacturing initiatives for
Lilly‟s Neuroscience (CNS) products and all projects in the large CNS pipeline. During my time in this
assignment, I was also asked to provide substantial business guidance in the development and management
of our CNS product/project portfolio, and I drove the portfolio management process within the business
unit.
I was involved in major initiatives to develop and implement both a CNS Business Strategy, as a core
member of the CNS Strategy Team, and an overall Lilly Corporate Strategy, as a member of the Corporate
Strategy development project.
Director of BioProcess Purification Development and Technical Services,
Lilly Research Labs

4/92 to 4/95
I was responsible for the development of purification processes, manufacture of clinical material, scale-up to manufacturing, validation and startup, and ongoing technical support for Lilly‟s bioproducts (such as Humulin, Humatrope, Humalog, and pipeline bioproducts). This assignment involved the management of more than 150 scientists, engineers, and pilot plant technicians (including 10 senior development labs, 3 senior technical service labs, a technical service support group, a process engineering group, and 3 pilot plants). In addition, in this job, I was the business leader of an effort to better define Lilly‟s overall bioprocess capabilities and to create a more robust Lilly Biotechnology Strategy. This effort led to a renewed expansion of our overall biotech R&D and manufacturing efforts, and a re-organization to provide more corporate focus in these areas. Manager (Associate) of Strategic Facilities Planning,
Global Manufacturing and Supply Services

11/89 to 4/92

As first a senior associate and then as the manager in Facilities Planning, I was responsible for capital
projects planning for Lilly‟s worldwide bulk manufacturing facilities. This included several major capital
expansion projects and new product initiatives.
Jacobs Engineering
Manager of Process Engineering
8/87 to 11/89

I was involved as a Senior Process Engineer, Project Engineer, or Biotechnology Consultant on several
projects to design, build, and commission pilot plant and/or production facilities (primarily in the
biotechnology area). The client companies for these various projects included Genetics Institute, Chiron,
Chugai, Codon, Applied Biotechnology, Enzon, VetGen, Phillips Biotech, and Biopure.
On one of these projects (the supply of mammalian cell culture bioreactor systems for Chugai
Pharmaceuticals in Japan), I did both the conceptual and detailed design of the bioreactor systems,
specified and ordered the components and support systems, supervised the fabrication of the bioreactors
and the assembly of the bioreactor systems, drafted the qualification, validation, startup, and operational
procedures, and helped supervise the installation, qualification, validation, and startup of these systems in
Japan. These bioreactor systems have served as the basis for Chugai‟s mammalian cell culture
manufacturing since their startup in 1989. Based on relatively recent feedback from Chugai, the
operational performance of these bioreactor systems, over more than 10 years of service, has been
exceptional.
Genetics Institute

Senior Vice-President of Development, Engineering, and Manufacturing
9/86 to 8/87

I was responsible for all process development and manufacturing activities. This included groups working
on mammalian cell culture, insect cell culture, microbial fermentation, protein and biochemical
purification, formulation, product characterization, biochemical engineering, facilities design, pilot plant
operations, and manufacturing (totaling more than 200 scientists, engineers, and technicians).
I was a member of the Genetics Institute Operations Committee (the most senior corporate group) and a
member of the WelGen Board of Directors (the JV between Genetics Institute and Burroughs Wellcome).
I led the above groups in the commercial development of recombinant proteins for human therapeutic use
(such as tissue plasminogen activators, colony stimulating factors (GM-CSF, IL-3, & IL-6), erythropoietin
(EPO), factor VIII, and factor IX, specialty chemicals (such as enzymes, amino acids, diols, and long chain
diacids), and microbial pesticides and herbicides. This development included advanced technology for the
production of many of these products at commercial scale.
Vice-President of Process Development
9/85 to 9/86
I was responsible for all process development and clinical/test product manufacturing. This responsibility included organizing and staffing the process development area, and identifying the support needs for the various development groups. During this time, these groups were responsible for the production of three products for clinical testing; including the development of the process, manufacture of the material, and much of the support characterization for the IND submissions. Director of Pilot Operations and Process Engineering
8/84 to 9/85

I was responsible for directing the overall engineering effort and the pilot plant operations (including the
manufacture of protein therapeutics for clinical testing). I hired and trained key personnel in both groups,
established the documentation/operations framework necessary to insure compliance with the FDA‟s
Current Good Manufacturing Practices guidelines, started up and validated the pilot facility, and transferred
our process technology to our client companies, including assistance to them during the startup of their
manufacturing facilities.
Manager of Biochemical Development
2/82 to 8/84

I joined as the second member of the Biochemical Development Group, and the company‟s only engineer.
Thus, I was primarily responsible for project assessment (technical, process, and cost feasibility) and cost
estimation. In addition, I acted as a general consultant to the company in all engineering disciplines. I
designed and ordered the equipment needed to initially set up our operations, and helped to staff the
fermentation, purification, and cell culture development labs. I ran each of these labs for an interim period
while staffing was being recruited, hired, and trained.
In addition, I was the Project Manager for the design and construction of Genetics Institutes facilities,
which included administrative offices, R&D labs, a pilot facility, and all supporting services. This included
providing the process design, detailed equipment specifications, and construction/installation supervision
for the pilot facility.
Eli Lilly and Company

Department Head, Chemical Manufacturing
6/81 to 2/82

I was selected to organize a new department and commission a large, highly automated chemical
manufacturing complex. Control of this complex was based on a distributed network of computer
workstations.
I was responsible for coordinating startup activities, selecting and training production supervision and
operating personnel (a staff of 65), and establishing initial production.
Department Head, Antibiotic Purification
1/79 to 6/81

I ran a department of 85, responsible for the purification of several major fermentation/biochemical
products, including cephalosporin C and tylosin. This involved close interaction with the fermentation,
quality control, technical services, analytical, engineering, production planning, and other groups. I
contributed to in-process efficiency, operational techniques, and departmental organization. One such
improvement was the establishment of a highly successful “Q.C. Circles” program within the department.
Process Engineer, Fermentation Pilot Plant
4/78 to 1/79

I provided engineering support for a modern, high technology fermentation facility composed of
approximately 70 fermentors (40 to 4000 liter capacity).
I participated in the development, design and installation of computer based process controls, feed systems,
and sterile piping for the fermentors.
I was involved in the conceptual design of the first pilot scale fermentor in the United States approved for
use with recombinant strains (recombinant DNA produced insulin). This included helping draft and review
sections incorporated into the original NIH guidelines for rDNA, Large Scale.
Process Engineer, New Process Development
9/75 to 4/77

I developed, piloted, and designed a radically new process for the sterile production and filling of injectable
pharmaceuticals, used to manufacture several major cephalosporins. The project required innovative
solutions, applied in a practical manner, to several major problems encountered during the process
development phase. This required the design and construction of unique equipment and systems for the
final production facility, such as an aseptic continuous drying tunnel and an automated dose control system.
Process Engineer, Penicillin Purification
4/75 to 9/75

I provided process engineering support for the initial purification steps for penicillin V production.
Concentrated primarily on improved process control and installation of more efficient production
equipment.
Corporate Engineering, Design and Construction
7/74 to 4/75

I worked on the design of a new facility for the extraction and purification of bovine/porcine insulin,
vincristine sulfate, and other small volume biologicals.
E.I. Dupont de Nemours and Company, Inc.

Process Engineer, Dacron Production
6/73 to 7/74

I provided technical support for a continuous polymerization process used to manufacture polyethylene
terephthalate (Dacron) monofilament „yarn‟ and bulk fiber.
ACADEMIC BACKGROUND
Indiana University


Rose-Hulman Institute of Technology

Minnesota Governor‟s Bioscience Council (Former Member) MNBIO Board (Former Member) Society of Industrial Microbiologists (Former member) American Chemical Society (Former member) 1. Schmidli, B., “Using Bioprocess Manufacturing as a Strategic Advantage,” BioProcess International Conference, Keynote Address. (Nov. 2006) 2. Adamson, S.R. and Schmidli, B., “Industrial Mammalian Cell Culture,” Canadian Journal of Chemical Engineering, Vol. 64, (Aug. 1986). 3. Schmidli, B., “Biological Control of Fermentation Facilities,” Presentation at the XXV 4. Schmidli, B. and Swartz, R., “Design Considerations for Aseptic Fermentation,” Presented at the 184th American Chemical Society National Meeting. (1982)

Source: http://www.kelley.iu.edu/CBLS/files/B%20%20Schmidli's%20CV%20(19Aug09).pdf

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