Mons, Walloon Region, Belgium
Experienced professional in the biopharmaceutical industry, with a strong technical background in (bio)pharmaceutical processes, downstream purification, and product development. I have a proven track record of leading cross-functional teams and managing complex projects in both laboratory and manufacturing environments, fostering a culture of collaboration, innovation, and compliance. With expertise in Quality Assurance, I’ve supervised QA operations, managed deviations, CAPAs, and change controls, and supported internal and external audits, ensuring strict adherence to GMP standards. My strategic guidance has helped streamline processes, improve product quality, and mitigate risks, working closely with third-party vendors to maintain operational continuity. In addition to my leadership in scientific and quality-driven environments, I’m passionate about mentoring and empowering emerging professionals. As an ISPE Emerging Leaders Board Member, I contribute to global initiatives aimed at advancing the careers of young professionals in the life sciences, promoting knowledge sharing and professional growth.
Provide strategic GMP guidance to third-party vendors and partners. Drug Substance manufacturing network QA lead. Define and review quality agreements with external parties. Monitoring of the performances of vendors. Execution of qualification and routine GMP audits of vendors. Global Deviation process owner. Conduct or supervise QA activities such as product complaints, deviations investigations, CAPAs, change controls, batch records review, product release. Support mock recalls. Review of process qualification protocols and reports, method validation protocols and reports, stability plans and reports, specification documentation, CoAs, Quality sections of clinical dossiers and BLAs, etc.
The International Society for Pharmaceutical Engineering brings together more than 20 000 pharmaceutical professionals from 90 countries around the world. The Emerging Leaders committee consists of young professionals working in the life science industry and together we strive to provide a platform for knowledge sharing and networking within the life science industry, having a positive impact on young professionals early in their careers.
Led a QA Operations team of 14, including coaching, and recruitment. Served as the primary quality representative for Purification activities, ensuring regulatory compliance. Integrated the QA Ops team onto the shopfloor to enhance communication and collaboration. Oversaw batch records review to ensure product quality and consistency. Managed deviations and change controls, aligning processes with quality standards. Supported internal and external audits, emphasizing quality and regulatory compliance. Provided quality support for strategic site projects, from conception to execution.
SME in downstream antibody/protein purification and filling processes. Led investigations using Six Sigma/DMAIC methodologies for process improvement. Authored study protocols and reported results with precision. Monitored yields and process parameters to optimize productivity. Implemented strategies to mitigate risks and ensure operational continuity. Provided cross-functional training on scientific and technical topics.
Acted as a back-up for the manufacturing manager, ensuring operational continuity. Facilitated the transition of an A1PI drug purification line from project to routine production. Coordinated peripheral manufacturing activities (maintenance, validations, EM, shutdowns). Led quality investigations, identifying issues and implementing solutions. Implemented CAPAs to improve production quality and processes. Developed lean and digital tools to enhance team efficiency. Monitored KPIs to optimize production line efficiency and productivity.
Developed innovative synthetic routes and improved procedures for cyclic polymer preparation. Created a mass spectrometry protocol for assessing cyclic material purity. Evaluated cyclic materials' physico-chemical, biological, and biomedical properties for potential applications. Authored 8 peer-reviewed publications, including 5 as the lead author.
Led practical lab sessions in Organic Chemistry and Polymer Science for 5-20 students. Provided supervision to help students understand complex scientific concepts and improve lab skills. Conducted student evaluations and offered feedback to support academic progress.
Supervised 4-10 researchers within the Polymer department. Conducted training on Good Laboratory Practices (GLP) and Health, Safety, and Environment (HSE) standards. Mentored undergraduate and graduate students on complex research projects. Managed chemical and disposable inventories for efficient lab operations. Acquired advanced lab equipment, optimizing budget for research enhancement. Ensured compliance with environmental regulations for waste treatment processes.