Londerzeel, Flemish Region, Belgium
7+ years CMC experience in biotech and pharmaceutical industry. CMC Leader with expertise in Drug Product Development from preclinical till registration phase. Know-how of process and formulation development, GMP manufacturing, QP release and clinical supplies according to regulations. Experienced as CMC representative in cross-functional settings. Make-it-happen attitude.
Experience in formulation and process development, including scale up and technology transfer, with a focus on Life Cycle Management for the Japanese market. Coordination of the development of pharmaceutical formulations and manufacturing processes to support analytical testing, stability assessment and clinical trial supplies. Focus on development strategy for amorphous solid dispersions.
Development of long-acting injectable formulations for poorly soluble anti-HIV compounds Supervisor: Prof. Guy Van den Mooter Experience with various activities involved in the drug development process ranging from product manufacturing, over sample characterization, in vitro release testing and in vivo bioavailability assessment. Focus on injectable controlled release formulations of poorly soluble drugs with techniques varying from spray drying and solid state analysis to surface characterization techniques.