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December 2002

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The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Subject:
From:
"Eric F. Celidonio" <[log in to unmask]>
Date:
Wed, 18 Dec 2002 09:22:48 -0500
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A tall order! Well compensated though.

POSITION:  Clinical Microbiologist

DEPARTMENT:  Anti-Infectives Research

RESPONSIBILITIES: In this dual capacity position, you will establish a
clinical microbiology function to support the Companyís anti-infective
discovery research and clinical development groups. Discovery Research:
Study organisms and their constituent activities and structures to
understand disease processes leading to the discovery of novel therapeutic
agents. Clinical Development: Assess, recommend and coordinate clinical
microbiology activities in support of clinical trials and IND/NDA
submissions. Develop and apply study methods to examine effects of
antimicrobials on the characteristics and growth of bacteria and other
micro-organisms to help better understand their relation to specific
disease. Develop benchmark studies which advance the Companyís clinical
candidates and present findings at conferences and other appropriate venues.
Coordinate clinical microbiology activities for in-vitro studies. Apply
microbial physiology techniques relating to MICís and mechanism of action
studies to characterize properties of anti-microbial agents pertaining to
their pharmacokinetic and pharmadynamic properties. Work in close
partnership with scientists in Anti-infectives Discovery, Lead Discovery and
Clinical Development personnel to help advance internal programs and
clinical candidates. Prepare and present scientific progress of assigned
projects pertaining to clinical microbiology and submit data and text
required for the timely submission of regulatory documents. Link microbial
physiology research function with clinical development activities and ensure
that clinical microbiology expertise is accurately and timely represented in
the Companyís candidate assessment and development programs. Act as overall
coordinator of clinical microbiology activities required to support
pre-clinical and clinical development activities. Identify, validate and
coordinate materials and processes pertaining to the effective utilization
of third party microbiology labs used in Company sponsored drug trials
including the review of testing protocols and management reporting system to
ensure that Companyís needs are met. Coordinate the collection of
microbiological data and assist in the interpretation and its application to
clinical trials management. Conduct inventory of microbiological data from
third party labs and identify gaps and recommend and coordinate corrective
action plans. Provide instructive guidance to discovery and clinical
development personnel to facilitate accurate understanding of regulatory
requirements relating to clinical microbiology. Collect, interpret and
provide required clinical microbiology information in the submission of
IND/NDA regulatory filings, and manage document process flow to ensure
timely submission of appropriate section(s). Establish accurate tracking
system of clinical microbiology activities collected from third party
resources utilized by the Company in its drug trials. May establish a small
clinical microbiology lab within the Company capable of performing routine
microbiological studies to drive and support new product innovation. Provide
insights to internal marketing and clinical professionals in field of
expertise in support of ongoing and new trials, publications, protocol
development and changes. May directly or through third party personnel,
perform laboratory tests and relevant analysis which elucidate information
helpful in protocol development, potential new indication and overall trial
performance.

EDUCATIONAL BACKGROUND:  Minimum of MS in Microbiology or Microbial
Physiology (Ph.D. preferred). Minimum accreditation as a Registered Clinical
Microbiologist (NRM) or equivalent accreditation with focus on biological
safety microbiology. Specialist Microbiologist (NRM) designation desirable
or equivalent accreditation.

REQUIRED EXPERIENCE:  Minimum of 5 years direct experience as a bench
microbiologist and/or clinical scientist directly related to the discovery
and clinical development of anti-infective agents and collection,
interpretation and submission of clinical microbiology data in support of
IND/NDA filings.

ADDITIONAL INFORMATION:  Knowledge of microbiological GMP/GLPs and
validation of microbiological test methods and procedures. Extensive
knowledge of regulatory requirements pertaining to clinical microbiology
data and submission of IND/NDA filings. Expert knowledge and abilities
pertaining to the isolation, identification, and susceptibility testing of
microorganisms from clinical specimens in accordance with the National
Committee of Clinical Laboratory Standards (NCCLS). Knowledge and expertise
of third party clinical microbiology lab processes and services. Familiarity
with pharmacodynamic models in experimental animal infections. Extensive
knowledge of microbial physiology and experience with MICís and solid growth
medium formats assays used to characterize properties of antimicrobial
agents pertaining to its pharmacokinetic and pharmadynamic properties. Cell
based assay expertise. Able to work with multi-disciplined teams in the
pursuit of and optimization of drug leads and pre-clinical and clinical
development programs. Highly flexible and adaptive. Excellent written and
communication skills. Well developed interpretative skills. Working
knowledge of activity based tracking system. Expertise in the use of
computers to populate, analyze and apply microbiological data to discovery
and clinical development programs. Well developed influence management
skills. Highly collaborative. Well developed ability to multi-task and
coordinate third party activities. Able to effectively interpret
multi-faceted data sets and present findings in a concise manner.




Eric F Celidonio
OneScience, Inc.
PO Box 7549
Brockton, MA 02303-7549
508-580-4950 Office
508-923-0950 Remote Office
508-256-3081 Fax
www.1sci.com
mailto:[log in to unmask]

We Donate 5% of our net to health related non profit and charitable
causes--making a difference is important to us!





  -----Original Message-----
  From: The Pharmaceutical Microbiology Mail List
[mailto:[log in to unmask]]On Behalf Of Anger_Claude
  Sent: Tuesday, December 17, 2002 7:48 PM
  To: [log in to unmask]
  Subject: Re: [PMFLIST] Thermophiles in WFI


  Chris,
  I agree with Bob Freidel, looking for thermophiles in your water system is
nonsense. Do you get your water supply from Yellowstone National Park
gysers, or does your local city water supplier pass their water through a
compost pile, if none of these are true then looking for thermophiles inyour
80C water loop is "nonsense".

  Claude Anger
  Director, Pharmaceutical Microbiology
  Allergan, Inc
  [log in to unmask]
  FAX # 714/ 246-4525

    -----Original Message-----
    From: Bob Friedel [mailto:[log in to unmask]]
    Sent: Wednesday, December 11, 2002 4:04 PM
    To: [log in to unmask]
    Subject: Re: [PMFLIST] Thermophiles in WFI


    It is not necessary to monitor for thermophiles.

    Bob Friedel
    [log in to unmask]
      ----- Original Message -----
      From: Chris Nguyen
      To: [log in to unmask]
      Sent: Tuesday, December 10, 2002 5:58 PM
      Subject: [PMFLIST] Thermophiles in WFI


      Hi group

      We have a hot WFI system in our company: 80 C. We perform routine WFI
testing, and incubate the samples at 30-35 C. My concern is thermophiles
could be survived in this condition (80 C), so any guidelines or
requirements to have additional samples and incubate them at higher
temperature such as 55-60 C to detect thermophiles?

      Thanks in advance

      Chris







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    ------------------ The PMFList (http://microbiol.org/PMFList_info.htm)
is operated from The Microbiology Network (http://microbiol.org) and
supported by our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.

    Please take a second to visit our sponsors' web sites and say thank you
for their support of this service. AAI - http://www.aaiintl.com/Micro.htm
Accugenix - http://www.accugenix.com/ Becton Dickinson Microbiology
Systems - http://www.bd.com/industrial Chemunex - http://www.chemunex.com/
Microcheck - http://www.microcheck.com/ MIDI - http://www.midi-inc.com/ MIDI
Microbial ID - http://www.microbialid.com/ MIDI Labs -
http://www.midilabs.com/ Millipore - http://www.millipore.com/



  ------------------ The PMFList (http://microbiol.org/PMFList_info.htm) is
operated from The Microbiology Network (http://microbiol.org) and supported
by our sponsors (http://microbiol.org/sponsor.htm) as a service to the
scientific community.

  Please take a second to visit our sponsors' web sites and say thank you
for their support of this service. AAI - http://www.aaiintl.com/Micro.htm
Accugenix - http://www.accugenix.com/ Becton Dickinson Microbiology
Systems - http://www.bd.com/industrial Chemunex - http://www.chemunex.com/
Microcheck - http://www.microcheck.com/ MIDI - http://www.midi-inc.com/ MIDI
Microbial ID - http://www.microbialid.com/ MIDI Labs -
http://www.midilabs.com/ Millipore - http://www.millipore.com/




------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
AAI - http://www.aaiintl.com/Micro.htm
Accugenix - http://www.accugenix.com/
Becton Dickinson Microbiology Systems - http://www.bd.com/industrial
Chemunex - http://www.chemunex.com/
Microcheck - http://www.microcheck.com/
MIDI - http://www.midi-inc.com/
MIDI Microbial ID - http://www.microbialid.com/
MIDI Labs - http://www.midilabs.com/
Millipore - http://www.millipore.com/




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