Speaker Biographies
2008 Conference on GMP in Microbiology
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Lucia Clontz
Lucia Clontz is the Director of Microbiology and Chairman of the
Operational Excellence Team at Diosynth Biotechnology, a
Division of Schering-Plough, located in RTP, NC. Lucia has
expertise in pharmaceutical microbiology and for more than 20
years has managed numerous validation projects, established
quality systems for microbiology laboratories, and participated
in compliance audits. In her previous position as a consultant
and Director of Regulatory Compliance at Serentec, Inc., Lucia
helped clients find effective and practical solutions for
microbiology issues associated with facilities, processes, and
laboratories. Lucia has a B.S. degree in Chemistry, with minor
in Chemical Engineering and a B.S. degree in Marine Sciences,
and holds a Masters of Science degree in Microbial Biotechnology
and a Graduate Certificate in Molecular Biotechnology from the
North Carolina State University, NC. Lucia is a member of the
Parenteral Drug Association (PDA) and a co-founder of the
Pharmaceutical Microbiology Forum (PMF) Organization and the
Biofilm Networking Group.
 Luis Jimenez
Dr. Luis Jimenez is Associate Director-Microbiology at
Immunomedics Inc. in Morris Plains, New Jersey. Currently in
this role, Dr. Jimenez is leading the Microbiology program to
support the Cell Culture and Aseptic Manufacturing of monoclonal
antibodies and other biotechnology products. He completed his
Ph.D. in Environmental Microbiology at the University of Puerto
Rico and performed his dissertation research at the Savannah
River Plant in South Carolina under a predoctoral fellowship in
Bioengineering and Microbiology from the Department of Energy of
the United States and the National Institutes of Health. He
completed Post-Doctoral studies in Environmental Biotechnology
at the University of Tennessee, Knoxville. Dr. Jimenez has 15
years of industrial experience in the biotechnology and
pharmaceutical industry working for companies such as Reckitt
and Colman, GlaxoSmithKline (formerly Block Drug Company),
Hoffmann-La Roche, etc. He has developed or participated in the
development of several products for clinical and environmental
applications. Dr. Jimenez’s expertise in these areas is
reflected in 47 publications, 7 book chapters, 1 book, 1 patent,
and 65 presentations.
Karen McCullough
Principle, MMI Associates
Karen Zink McCullough is a veteran of LAL compliance and
technology. She has been working with the bacterial endotoxins
test since 1973 and in 1975, she published the first paper on
the use of BET in small volume parenterals. She also was the
driving force organizing the LAL Users Group. Karen is a highly
regarded GMP trainer and organizer of professional development
programs. Ms. McCullough holds a Bachelor’s degree in
bacteriology from Douglass College (Rutgers University) and a
Master’s degree in Molecular Biology from the University of
Oregon.
David Porter, Ph.D.
Director of Training, Vectech Consultants
David Porter has an industrial/compendial background in
microbiology, in vitro toxicology, and the application of
statistics to experimental design, data analysis, and
validation. His experience includes microbiology laboratory
management, cell biology laboratory management, and management
of biostatistics in a clinical affairs group.
He also has extensive experience pertaining to compendial
affairs and their relationship to the FDA. He has employed
statistical analysis in the development of new products, for two
of which he is a co-holder of new product patents.
He has validated numerous novel test procedures, and
performed both prospective and retrospective analyses leading to
new product claims. He has effectively developed matrix
approaches for laboratory and compendial operations. David has
effectively taken broken processes and through team leadership,
repaired them. He is an effective developer and instructor of
training materials for technical audiences. David believes that
effective consultation involves at least in part an educational
process whereby the clients learn how to better address problems
in the future. He is experienced in the development of SOPs for
quality systems, and has performed numerous external and
internal audits to determine compliance. While at the United
States Pharmacopeia (USP), he served as a Scientist, Senior
Scientist, Associate Director and Director, all within the area
of general chapters. He also led the a matrix team responsible
for the development of a software package presenting an
attractive graphical user interface with which to access the
corporate revision-related database. His particular
concentration while at USP pertained to general chapters
pertaining to microbiology and biotechnology. His Ph.D. is in
Zoology from the University of California at Berkeley . He
is a member of the USP Microbiology and Sterility Assurance
Expert Committee.
Donald Singer, M.S.
Donald C. Singer is a Certified Specialist Microbiologist in
consumer and industrial microbiology and a Malcolm Baldrige
National Quality Award Examiner. He is a second term member of
the USP Microbiology and Sterility Assurance Expert Committee
and has participated on the advisory team for the ICH working
group on harmonization of global microbiological methods. Singer
has been a member of the Food Drug and Cosmetic Division of the
American Society for Quality (ASQ) since 1982, was chair of the
FDC Division in 2003-2004 and is presently a National Director
of ASQ. He has 30 years of research, quality control, quality
assurance, and laboratory management experience in the
pharmaceutical, cosmetic, food, beverage, hospital products and
medical device industries. He is a co-author of "Laboratory
Auditing for Quality and Regulatory Compliance", and editor of
"A Laboratory Quality Handbook of Best Practices", as well as
author of various other journal publications dealing with
microbiology laboratory practices, sanitation awareness in
manufacturing, microbiological control of water systems, and
sanitary engineering. He has developed and taught courses
concerning microbiological control, cGMPs, personal hygiene and
product safety, including an ongoing series of workshops for the
American Society for Microbiology and is a visiting adjunct
biopharmaceutical instructor at the University of Maryland. He
has been a member of the AOAC Technical Laboratory Accreditation
committee which developed the Criteria for Laboratories
Performing Microbiological and Chemical Analyses in Foods, Feeds
and Pharmaceutical Testing to complement ISO 17025, and most
recently a member of the AOAC Laboratory Proficiency Testing
Program Advisory Committee and the Presidential Task Force on
Best Practices in Microbiological Methodology. Singer holds a
Masters degree in microbiology from the University of Dayton.
 Scott Sutton
Senior Director of Microbiologic Services, Vectech
Dr. Sutton earned his Masters and PhD in Microbiology from the
University of Rochester (NY). With over 20 years of laboratory
leadership experience in the microbiology arena of the
pharmaceutical and personal products industries, he now consults
through Vectech Pharmaceutical Consultants, Inc. Clients have
included startups, generics, established Fortune 500 companies,
law firms and investment broker houses. Laboratory management,
training, GMP, testing methodologies and microbiology-related
project management are areas of special interest. He has worked
with the USP Microbiology Committee of Experts since 1993,
serving as vice-chair since 2000. He operates the Pharmaceutical Microbiology Forum with
its monthly newsletter (http://www.microbiologyforum.org)
and serves as a reviewer for several peer-reviewed journals.
Dr. Sutton also operates an information source on the internet –
The Microbiology Network (http://www.microbiol.org)
that provides services to microbiology related user’s groups.
This service also supports two Email lists, the first devoted to
pharmaceutical microbiology (http://www.microbiol.org/pmflist.htm)
and the second devoted to pharmaceutical stability (http://www.microbiol.org/psdglist.htm).
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