Belgium
As a CMC Drug Substance leader with > 10 years of experience in the pharmaceutical industry, I design and execute drug substance development, troubleshooting and supply in line with project needs. Technical skills: - Knowledge of regulatory and quality requirements for different clinical phases of development, GMP and ICH guidelines - Proven experience in CDMO/CRO management and technology transfers - Hands-on experience in chemical process R&D Soft skills: - Strong written and verbal communication skills and teamwork - Flexibility and adaptability to changing timelines and priorities - Organisational skills
- Definition and execution of integrated drug substance development strategies according to the project development objectives in the small molecules area - Selection of CDMOs and CROs, setting up of collaborations, technology transfers and management of external vendors, and the associated budget - Oversight of outsourced drug substance development activities for early development from discovery stage (non-GMP and GMP: route scouting, solid form screening and development, chemical process R&D, scale-up, GMP manufacturing at CDMOs, RSM sourcing) - Management of supply chain and related activities to ensure availability of drug substance for preclinical and clinical activities (non-GMP and GMP) within agreed timelines, with phase-appropriate quality and related regulatory and quality documentation - Management of technical transfers between CROs/CDMOs. Preparation and review of related documentation (technology transfer packages, MBR, EBR...) - Preparation and/or review of documentation in view of regulatory submissions (risk assessments, reports...) - Participation in the definition of drug substance development and supply strategy for CMC - Close collaboration with numerous stakeholders (CMC team members, external vendors, Quality, discovery scientists, preclinical leaders...) - Setting up the sustainability strategy for drug substance development - Knowledge of ICH guidelines and GMP
2016-2020: Process development and transfer towards GMP manufacturing (synthetic peptides) - Management of a team in the lab (2-3 technicians) working on chemical process R&D for multistep syntheses and purifications of pharmaceutical ingredients using QbD tools - Supervision of scale-up and production of non-GMP batches - Handling of aqueous solutions involving aseptic manufacturing - Management of project progress and communications: oral presentations, development reports - Preparation and review of regulatory and quality documentation (IMPD, MBR, change management...) - Management of technical transfers to GMP CDMOs - Referent for quality management in the chemistry department 2014-2016: Research in the field of large molecules as excipients of pharmaceutical interest (polysaccharides, synthetic peptides, small molecules) - Synthesis and functionalisation of new molecules. Areas of expertise: polymerisation, LPPS, peptide coupling, large molecule functionalisation, purification by diafiltration, analyses of large molecules - Management of a team in the lab (2 technicians) - Management of technical transfers to radiolabeling CDMOs
Postdoctoral research in Prof. Philippe Renaud's group Topic: Organoboranes in radical chemistry. - Work on several projects in the field of boron and radical chemistry. - Management of students and teamwork. - Writing of a scientific article and a research project proposal. - Keeping up-to-date with scientific advances. - Gained knowledge in heterocyclic chemistry (pyridines), hydroboration, radical reactions, boron chemistry, handling of very sensitive compounds...
PhD thesis in EPFL (Lausanne, Switzerland) and ICSN (Gif-sur-Yvette, France) under the supervision of Dr. Luc Neuville and Prof. Jieping Zhu. Topic: 3-hydroxyoxindoles: from the motif synthesis to the studies towards total syntheses of TMC-95A and azonazine. - Development of one methodology and work on two distinct total syntheses in parallel - Planing, design and execution of multistep synthesis, and analysis of the results using a wide array of analytical techniques (NMR, HPLC-MS, SFC, IR...). Identification of side-products of unknown structure. - Synthesis from mg to multigram scale. - Screening of reaction conditions and optimization. - Oral communication of results at team meetings and international conferences. - Keeping up-to-date with scientific advances. - Gained knowledge in heterocyclic chemistry (oxindoles, isatins...), homogeneous catalysis, organocatalysis, asymmetric synthesis, reactions involving aromatics, peptidic couplings, protecting groups, oxidations/reductions...