Turnhout, Flemish Region, Belgium
Scientific Director with extensive experience in pharmaceutical development, specializing in analytical method development, validation, and stability strategies for small molecules. Demonstrates strong leadership in managing multidisciplinary teams and fostering collaboration across global functions to ensure scientific rigor, operational excellence, and regulatory compliance. Recognized for deep expertise in chromatographic techniques, CMC leadership, and clinical release and stability testing, enabling robust solutions for complex challenges. Combines technical depth with strategic vision to accelerate drug development and deliver innovative medicines that improve global healthcare.
Drive end-to-end analytical method development, stability and clinical release for drugs in the synthetic portfolio: focus on Small Molecules and Peptides. - Deep understanding of drug development science, processes and regulatory requirements. - Proficient in analytical chromatographic techniques for drug characterization. - Responsible for the development and validation of chromatographic methods for drug substances and products. - In depth knowledge and overseeing stability studies and clinical release testing. - Collaborating across drug development teams to ensure consistent practices and methodologies. - People leader of Scientist/Analysts/People Leaders, including internal and external collaborators - Ensuring high-quality output and compliance with (GxP) regulations. - Managing team budget and resources.
Responsible to ensure the day-to-day operations of the Beerse located CRS laboratories: - coordination of the Release and Stability testing of clinical trial material (CTM) of compounds in Janssen small molecule pipeline (API, DP and P&L) - organizing efficient support in process characterization for API and DP process development - ensuring a cGMP compliant lab environment - people management of +50 scientist/analysts including internal and external collaborators - managing of budgets (FTE's, OOPs, CAPAX, travel/training,...) Furthermore, responsible for the scientific interpretation of CRS small molecule portfolio aspects and as such enabling the right first time development of projects. Functional CMC Leader: leading cross-functional CMC (Chemistry Manufacturing & Control) teams for several programs residing in early clinical development (discovery up to clinical phase IIa). Key objectives are the synthesis of the active drug, formulation development and providing supplies for clinical use. Besides understanding the scientific landscape, it is key to manage business risks, timelines and budgets/resources.
Responsible for scientific analytical development and program management of (small molecule) drug substances and drug products during early and late stage development up to commercial launch. Skill-sets that have been further developed: - expert in analytical sciences - design and implementations of (analytical) strategies - program management: planning, budgeting, data management,… - extensive interaction with multidisciplinary and multi-site groups - knowhow on regulatory analytical guidelines (EMEA, FDA) - GMP