1. Marie France Quillen
Cary, NC 27513
MFRQ@novonordisk.com - 919-750-5783
SeniorQC Microbiologist
Novo Nordisk – Clayton,NC – 2016to present
 Manage projects in DAPIUS forQC laboratory by making inputs in the layoutof the
laboratory. This includes placement of equipment, placement of methods in rooms
(separation of methods) and consequently where utilities are needed.
 Make inputs in the layout of the laboratory space and requirements to HVAC forfume hoods,
LAF benches (BioSafety Cabinets) and HPLC/UPLCcabinets
 Working with Clean Utilities forresource planning and system design forwater system
validation and Identifying additional system needing qualificationin QC laboratory
 Write URS’s forall B and C equipment in the QC laboratory
 Write IFA (InterfaceAgreement) with EM group
 cLEANrepresentative for QC
 EHS Ambassador forQC Micro/Biochemistry (PHAreview)
 Interviewed applicants forQC Senior Microbiologist
 Providedrecommendation on hiring EM project manager to develop the EMprogram
 Contributed to the design of the inoculation lab
 Redesigned the ID laboratory
QC Microbiology
Pfizer06/2005-01/2016
 Collaborated withthe LIMS team in the development and implementation of compliant and
effectiveassay
 Builds forseveral microbiologicalassays (GrowthPromotion, LAL, and TOC) in our
validated electronic Database.
 Provide Analytical department support as a subject matter expert in TOC (Total Organic
Carbon), Microbial Identification equipment and processes, and endotoxin testing
 Execute various method validation protocols such as purity, bioburden, slot blot, and
viability
 Primary analyst for disinfectant efficacy study
 Perform confirmation of working cell bank using Western Blot method
 Lead analyst for LIMS interface of EndoscanV software and operating system project for
BIOTEK and MCS
 microplate reader
 Troubleshooting assay and equipment as needed, mentoring and training analysts on assays
and industry practices.
 Execute equipment validation, data analysis, peer review of summary report for BioTek,
MCS microplate reader and TOC analyser
 Lean Labs (Standard hours, operation efficiency, )
 Revise & create SOPs
2009-20012
 Perform cell bank manufacture, oversight, and characterization testing of master cell banks
 Perform environmental microbial and yeast identification using standard morphology and
chemical testing in addition to BIOLOG, OMNILOG, VITEK & MALDITOF identification
systems.

2.  Execute various method validation protocols such as purity, bioburden, slot blot, and
viability
 Participated in equipment validation of the BIOLOG & OMNILOG (Microbial Identification
System))
2005-2008
 Performcryopreservation of microorganisms
 PerformPopulation Verification on in-house organisms and cell suspensions.
 Performbiological, biochemical, and immunological assays whichincluded bioburden, slot
blot, viability,
 purity, stability testing, antibody identification, media certificationand micro certificationin
support of in process,
 release and stability samples
 Test for presence of Bacterial Endotoxinin Productand Raw Materials samples via Kinetic
Turbidimetric and
 Chromogenic Method
 Conducted internal safety, housekeeping, and cGMP audits of Microbiology,Chemistry, and
Analytical labs
 to ensure readiness for Board of Health audits
QC Microbiology
Cardinal Health,BSLS -Albuquerque,NM - June2003to May 2005
 Responsible forenvironmental microbial and yeast identification using standard
morphology and chemical testing in addition to BIOLOGand OMNILOGidentification
system.
 Providedsupport to Validation department with Biological Indicator, EndotoxinChallenge
and ProcessValidation.
 Performed MicrobialPropagation and Stock culture maintenance.
 Performed Media Certification.
 Responsible forall Bacterial Endotoxin Testing (BET) including finished products, new
product validations, testing on experimental lots, and raw materials using gel-clotand
kinetic turbidimetric methods.
 Performed bioburden membrane filtration of finished products and raw materials.
 Performed the PQof the OMNILOG(Microbial IdentificationSystem) and TECAN (LAL
Microplate Reader).
 Performed Container Closure integrity testing.
 Processed Water Testing using membrane filtration,coliform and thermophile analysis.
 Trained new laboratory personnel on general laboratory procedures.
 Revised and created SOP'sforrelease assays and additional laboratory
 Reviewed data for Microbial Identification
 Responsible forordering officeand laboratory supplies for the whole Microbiology lab.
 Responsible forworking withexternal customers for method transfer and method
development forproducts contracted to be manufactured on site.
 Assay development and qualification forover 20 products
RETAILMANAGER
 Army & Air ForceExchange Service- Colorado Springs, CO - June 2000 to January 2003
CLINICALRESEARCHASSISTANT
 Kaiser Foundation HP Co - Denver, CO - November 1998 to April 2000

3. EDUCATION
 BACHELOROFSCIENCE inBIOLOGY
Metropolitan State College of Denver- Denver,CO -1998