Greater Toronto Area, Canada
- Scheduling of daily activities for potency and cell biology assay team - Test Method Transfer from/to sending receiving units - Qualification of cell based assay and potency methods - SME and qualified trainer on cell based, cell count and potency test method and instrument usage - Test Method performance monitoring - Writing & reviewing of all associated documents - Lead quality event resolution such as change controls, deviations, CAPAs, lab investigations for atypical results - Review of executed quality documents such as QC test methods and logbooks - Experience with Veeva and MasterControl QMS softwares
- Test Method Transfer from Assay Development team - Test Method Qualification - Test Method and Instrument Training - Test Method performance monitoring - Reference standards/reagents qualification and trending - Writing & reviewing of all associated documents - Lead quality event resolution such as change controls, deviations, CAPAs, lab investigations for atypical results - Review of executed quality documents such as QC test methods and logbooks - Experience with Veeva and MasterControl QMS softwares
- Implementation of mRNA manufacturing at GMP standards - Support GDP implementation, manufacturing team coordination and sample logistics - Production of mRNA batches for phase I & II clinical trials - Development, implementation and training on in-process control and release test methods including qPCR for residual testing, dot blot, capillary electrophoresis, fluorescence/plate assays, in vitro translation and SDS page, visual inspection and extractable volume… - Authorship of production batch records, analytical method SOPs, and equipment use and maintenance SOPs - Authorship of analytical method qualification protocols and reports - Equipment owner responsible for equipment qualification and preventative maintenance tracking - Design of personnel flow and environmental monitoring plan for GMP manufacturing area
Consulting in Pharmaceutical industry From April to October 2018, Project coordinator for QC Analytical Support at Sanofi Pasteur Val-de-Reuil: - Global quality documents gap analyses and risk assessments - Updates and Harmonization of site quality documents - QC method simplification, creation of method flowcharts with Visio - Creation and management of a QC SharePoint - Participating in analytical strategy to answer audit observation From June 2017 to March 2018, Project coordinator for global MTech at Sanofi Pasteur Val-de-Reuil: - management of new technologies network
Development of analytical assays for novel protein and virus-based vaccines. _ Implementation of a test for the detection of mycoplasma by Agar and Broth Culture Method (ABCM) _ Implementation of a test for the detection on mycoplasma by Indicator Cell Culture Method (ICCM) _ Evaluation of the robustness of the mycoplasma detection test by PCR and microarray (NAT) _ Preparation of mycoplasma stocks and characterization for identity, titer and QC/CFU ratio. Qualification of the stocks _ Mycoplasma stock stability investigation and spiked samples holding time study _ Preparation of the parallel validation for the 3 mycoplasma detection tests (ABCM, ICCM, NAT) _ Writing of associated documents : procedures, worksheets, instructions, validation protocol, development report _ Routine Sequencing of bacterial stocks and identity/purity verification (Illumina NextSeq) _ Setting of a lab room with equipment validation monitoring
_ Evaluation of the Argus – Whole Genome Mapping technology for bacterial typing of wild type, recombinant and vaccine strains. Comparison between Argus results and PFGE _ Evaluation of the technology for genetic stability among clones. Comparison between Argus and PFGE + Southern blot. _ Use of the in silico function of the software to facilitate the sequence alignment after HTS. _ Culture and conservation of bacterial strains used for the studies _ Co-writing of an evaluation report