Brussels Metropolitan Area
- Over 10 Years’ experience in vaccines business: 4 years in vaccine formulation development (adsorbed, freeze-dried and liquid formulation; early and late stages), 2 years in Global Regulatory Affairs (CMC file writing and submission, response to questions from the authorities…) and 4 years in Quality Control as project manager for analytical method remediation (method validation, comparability, short-term initiatives, Quality & cGMP mindset…). - Experience & capacity to work in a multidisciplinary environment and navigate in a complex matrix organization. - Continuous improvement mindset (customers and patients oriented…), DMAIC methodology, Quality by Design (QbD) knowledge
Initiation, development and management of Technical R&D product and process development project plan for prioritized vaccines in development.
Management of: - Short-terms initiatives: Management of troubleshooting cases by leading a transversal team (task force on analytical variability, reagent bridging, high repeat rate for viral potency testing…) - Long-terms initiatives: Project management with transversal team through planification tools (MSP, Binocs…) in a GMP environment (change control coordination…). Monthly reporting of the project status and its risks registry. Main deliverables: Automation of dilution with a liquid handler for a potency test and its validation/comparability. Development (DoE…) and validation/comparability of flow cytometry as potency test. Improvement of polyclonal antibodies production (alternative adjuvant, immunization protocols fine-tuning, initiation of monoclonal antibodies development…). Engaging/influencing key stakeholders into the project and by aligning GSK priorities and the project milestones. Regular interactions with regulatory affairs, Quality Assurance, Technical Lifecycle team, Operations and statistics for strategic input and advise. Other: DMAIC, QbD...
- Member of QC "subject matter expert" team: Support regulatory assessment for change control related to analytical method and critical reagents bridging. Quarterly update of the changes impacting QC activities (variation, new file, license cancellation…) for all GSK products. - Variations writing (CTD module 3): Large variety of variations including those affecting QC processes like improvement of ELISA method, new reference standard for ELISA testing… to addition of new manufacturing site for drug product process (type II). - Efficient collaboration with contributing disciplines (Site conformance, QC, Operations…) to deliver regulatory documents. - Overview of all vaccines commercialized by GSK and their related file content (primary to secondary operations, facilities and control of Drug Substance and Product)
Ph.D. in Pharmaceutical Science and Pharmaceutical formulation Conception and optimization of lipid-based systems intended to oral administration Main responsibilities: - Establishment of a cell culture room for the laboratory (contacting equipments and consumables suppliers, redaction of SOP, management and maintenance of the equipments…) - Development of protocols used to assess the cytotoxicity of lipid-based excipients. - Investigation of different lipid-based systems (SEDDS, SMEDDS) on intestinal permeability enhancement. - Teaching, training and supervising of many student trainees.
Transfer of a production line from the Danish to the Swiss manufacturing plant within the production department Main responsibilities: - Assisting the Project Team to implement and optimize the granulation, coating and tabletting process lines by generating SOP, the first version of batch report templates and the draft of the cleaning validation protocol. - Training of the operators on the manufacturing and cleaning procedures. - Being one of the link persons between the Project Team, the Maintenance & Engineering and the production department.
Determination and optimization of a method to distinguish chocolate of different origins by gas chromatography analysis of their aroma (GC-FID) Main activities: - Extraction of the aroma of chocolates coming from three different origins. - Optimization of a chromatographic method used to analyse the aroma.
Investigation of different cyclosporine A formulations intended to ocular administration on the treatment of cornea graft rejections and ocular inflammations - Analysis of the effects of different formulations on the improvement of the patient’s condition. - Proposition of a manufacturing process for the pharmacy department.