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: [log in to unmask] href="mailto:[log in to unmask]">Chris Nguyen
To: [log in to unmask] href="mailto:[log in to unmask]">[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

 



Do you Yahoo!?

------------------ 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/

Yahoo! Mail Plus - Powerful. Affordable. Sign up now

------------------ 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/