PX'Therapeutics
- Quality control engineer
2007 - 2013
A fixed term contract following by an unfixed one
I develop and validate analytical methods. I am able to manage a pharmaceutical project:
- characterization of cell banks
- production of preclinical and clinical batches: in process controls and batch characterization; characterization of proteins and antibodies
- stability study of a product
TECHNICAL SKILLS:
- Analytical methods:
Skills: Western Blotting, interest protein immunoenzymatic assay (ELISA), SDS-PAGE following by Coomassie Blue or Silver PAGE Staining revelation, Size Exclusion-HPLC, Reverse Phase-HPLC and HILIC-HPLC (impurities and interest protein), colorimetry assay, host cell proteins immunoenzymatic assay, spectrophotometry, endotoxines assay (LAL), IEF (1 dimension), mass spectrometry (MALDI-TOF and ESI), N-terminal sequencing, peptide mapping, amino acids assay, DNA quantitation (Threshold), Gas-Chromatography, SPE treatment for HPLC.
- Molecular biology: bacterial expression system
Skills: transformation, DNA amplification by PCR, cloning, plasmid DNA extraction and identification by enzymatic digestion.
Knowledge: DNA sequencing, bacteriophages research.
- Microbiology: bacterial expression system
Flask cultur and fermentation (5L, 40L Bioréactor), cell banks establishment and characterization (cellular viability, purity, identity, plasmidic retention), proteins over-expression.
- Immunology:
Polyclonal antibodies biotinylation and purification by rProteinA affinity chromatography.
OTHERS SKILLS:
- Writing of: Sample Operation Procedures, GMP sampling and controls plans, stability study plan, validation plan of analytical methods, results reports .
- Quality assurance guidelines (ICH), European Pharmacopea
- Molecular biology softwares: Sim Vector, Chromatophore Graphs, Expasy, Primer3, Clustal W.
- Power-point presentation.
- Management of a technician (1 year) and a student of 9th grade (1 week)
