Stetten, Grand Est, France
Overall 30 years experience in the pharmaceutical industry, within GMP environment: 20 years of manufacturing process development of oral dosage forms, including clinical supplies, scale up, technical transfers, validation and launches; 7 years of product technical management in the External Supply Organization for oral dosage forms (solids, liquids, semi-solids and inhalation) and currently in the on-site cleaning validation team. 4 years as cleaning validation lead for Novartis Stein small molecules manufacturing site, withinthe MSAT team I'm passionated in technical aspects of manufacturing technolgies and technics. I appreciate and strongly support team spirit, diversity, lessons learned sharing, open to ideas. I'm driven by Quality, and commited to engagements, timelines and costs. My professional objective is to strengthen and diversify my knowledge and experience in the pharmaceutical domain, making use of my experience to enhance the performance of the team I'm working in, and getting satisfaction from customers and patients From a private pointy of view, I love family events, travelling, and supporting people around me.
· Subject matter expert (SME) for Drug Product of small molecule, non sterile dosage forms. · Process owner of Drug Product small molecule, non sterile dosage forms validation for Sobi products. · Internal activities related to (external) manufacturing such as process changes, major/critical deviations, risk assessments and CAPAs · Internal and external SOP’s and manufacturing instructions. · Supervision of technical studies, qualifications and validations. · Support registration files, variations and market expansion · Lead and execute MSAT projects such as manufacturing process and cost improvement as part of LCM. · Support in sourcing evaluation of new Drug Product small molecule CMOs. · Technical lead for product transfer, scale up activities, validations and oversight of manufacturing of Drug Product small molecule in clinical and commercial phase.
Cleaning validation lead for small molecules manufacturing site, within the MSAT team
Formulation expert in TRD pharmaceutical development, Inhalation unit. In charge of the development of DPI formulations and manufacturing processes.
Lab head in TRD Inhalation unit, for the process development and clinical supplies of inhalation forms as DPI's and pMDI's
Lab head in TRD oral solid dosage form unit, in charge of the development of dry and wet granulation process development, including scale up and tech transfer. Responsible for the manufacturing of clinical supplies at pilot and commercial scale.