Michèle Heintz-Lutz

-Project management: implementation of an open space in production area, URS redaction, CAR approbation, specification review, timelines and cost challenging.
-Process validation and MFT (Media Fill Test): setting the process validation strategy for the Bioprocessing department, protocols and reports redaction, planning and coordinating validation runs with the production team
-GMP work: drawing up SOPs, investigation for production deviation, corrective and preventive action
-SAP Quality module implementation: Business team member as Production department representant

-Cleaning validation: setting the cleaning validation strategy for multi-product facility, protocols and reports redaction, planning and coordinating validation runs with the production team
-Lean six sigma project as team member

Microbiology research department
Subject:Viral titration by flow cytometry
Cell culture (HEK 293 and VERO cell lines), method development on Vaccinia virus (VV lister strain), Flow cytometry (Cytomics FC 500 MPL, Beckmann Coulter formation)

Subject: Human disease-related in cytochrome b studied in Saccharomyces cerevisiae
Enzymatic activity measurement, site directed mutagenesis, cloning, Biolistic transformation

Subject: Tumoral angiogenesis control by phosphodiesterases inhibition.
Western blot, Protein extraction , In vivo angiogenesis test

Subject: Creation and validation of a tumoral angiogenesis pattern to study the inhibition of this mechanism. Cell culture (HUVEC), DNA and RNA extraction ,Northern blot