Laetitia Muszkieta
IS Business Analyst for QC and R&D activities
Scientific Expert
Double Competency
Quality Control and Manufacturing
Solution Analysis
Non-Product Software Definition
41 years old
Driving License
Lentilly (69210) France
Employed
Open to opportunities
Based on my professional experiences , I have acquired strong knowledge in the design of diagnostic products. These knowledge are including the product conception phase involving R&D activities but also phases required for the delivery of commercial product.
Today I am acting as IS Business Analyst for the R&D and QC activities within bioMerieux. Acting as consultant, I support different business actors in the definition of their requirements and the conception of application adapted to their activities. Thus, I am involved within projects as team player with good communication skills, organization, flexibility, respecting time lines,supporting business departments and enforcing my expertise on diagnostic industry and information systems.
It is in this way that I bring my expertise on the development of new efficient, accurate, and innovative computerized solutions in the respect of the quality guidelines inherent to the diagnostic domain.
Today I am acting as IS Business Analyst for the R&D and QC activities within bioMerieux. Acting as consultant, I support different business actors in the definition of their requirements and the conception of application adapted to their activities. Thus, I am involved within projects as team player with good communication skills, organization, flexibility, respecting time lines,supporting business departments and enforcing my expertise on diagnostic industry and information systems.
It is in this way that I bring my expertise on the development of new efficient, accurate, and innovative computerized solutions in the respect of the quality guidelines inherent to the diagnostic domain.
Project Manager and Business Analyst for bioMérieux (ISR consulting)
bioMérieux
Since March 2015
Consultant
Marcy l'étoile
- Nephrocheck Project: Updates of the specific internal tools allowing the generation of knowledge bases for R&D and QC activities during the optimization of a new VIDAS® parameter
- CABMLE/ GLT Project: Update of the Global labbeling tool allowing the generation of barcodes for QC/QP activities
- Tempo Evo Project: Feasibility study for the update of quality control tools during the optimization of a novel diagnostic assay
- SampleBank Project: Deployment of the SampleBank application allowing the standardization of the patient data and associated samples for several bioMérieux R&D sites (France, USA)
- ELN Project: Requirements definition and upgrade of the ELN application (Electronic Laboratory Notebook)
R&D Project Manager in Microbiology
Institut Pasteur
April 2011
to October 2014
- Organization and coordination of innovative R&D projects involved in the diagnostic and treatment of the pulmonary invasive aspergillosis
- Characterization of novel antifungal agent's mode of action
- Identification of new antifungal targets
- Optimization of a novel test of diagnostic by real-time PCR
- Production of recombinant proteins with biochemical interest
- Optimization of new experimental protocols
- Mentoring of laboratory technician
- Writing of seven research articles and one book chapter
R&D Project Manager in Molecular Biology
BayerCrospscience
September 2007
to January 2011
- Organization and development of an R&D project involved in the identification of potential antifungal targets in the rice blast fungus Magnaporthe grisea
- Writing of the grant and final report
- Realization of experimental procedures
- Mentoring of three undergraduate students
- Proactive management of risks
- BPL et HSQE training (monthly internal audit)
University Diploma in Bio-industries Professional vision. UCLY, LYON
University Catholic of Lyon
September 2007
to January 2011
M. Sc. Cellular and Molecular biology and Oncology. Specialty: Functional Genetic, Microbiology.
University Claude Bernard Lyon 1
September 2005
to June 2007
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English
Good
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French
Expert
- Definition and Prioritization of User Requirements (URS)
- Workshop et Brainstorming Organization
- Risk Analysis linked to the application development
- Choice of the Integrator after benchmark
- Wrinting of the Functional Requirement Specifications (FRS)
- Approval of the technical documentation linked to the application
- Wrinting and Execution of Verification testing activities
- Support Business Representatives in the Validation Phase
- Wrinting of the training sessions
- Reporting and Communication on activities
- Solution Implementation according to quality guidelines
- Apply NPS methodology and Change request process
- Partnership management (Sanofi, Biomérieux, Bioaster, Solution Integrator)
- Project Plan Definition and coordination
- Project Risk Management
- Budget Definition and Monitoring
- Quotation request
- 21CFR part 11 for Non-product Software
- GMP= Good Manufacturing Practices
- GCP= Good Clinical Practices
- Utilization of prediction softwares and databases for molecular design, and sequence comparison: BLAST, ClustalX, TMHMM, SignalP
- phylogeny: Genedoc, PhyML,
- Analysis of transcriptomic data: GeneData Analyst, EdgeR.
- Design of real time PCR probes: Primer express, molecular beacon
- Genetic map and cartography: Vector NTI
- Micro-organisms Culture (fungi, bacteria, yeast) in liquid and solid media, fermentor.
- Antifungal and Antobiotics suceptibilities
- Antifungal mode of action Analysis
- Phenotypic Characterization of mutated strain
- Immuno-labelling in situ.
- Cytokines dosages by ELISA method
- Cells culture
- Primary cells Isolation.
- Cytotoxicity Tests
- Molecular Design: Genetic construction and design of specific probes
- Nucleic Acid Extraction : ADN, ARN
- PCR Methods: Real-time PCR (Sybergreen, Taqman, Nested PCR), Double joint PCR, RT-PCR
- Genetic Transformation Processes (fungi, yeasts, bacteria)
- Southern/Northern/Western blots
- Transcriptomic Data Analysis
- Deletion Mutant Bank construction
