AKKODIS - Drug Product Development and CMC Leader - Life Sciences - M/F/X

About the RoleAs Drug Product Development (DP) Leader within the CMC team, you will provide drug product development expertise for the further development of the project. You will manage the clinical bulk supply for a late-stage small molecule program (currently Phase 2 – capsule; Phase 3 tablet development in progress). The development and manufacturing activities are outsourced to external service providers (ESPs). In this key role, you will contribute your deep pharmaceutical expertise—especially in solid dosage form development—to drive the success of the project. Key ResponsibilitiesLead the development and supply of drug product materials in line with the overall CMC and clinical strategyDevelop CMC strategyRepresent CMC within the project teamAlign on strategy, planning, activities and ensure effective coordination of CMC teamManage the CMC budget and report updates to the project teamOversee the (bulk) manufacturing of development batches and GMP batches for clinical purposesAnalyze formulation and process data, and adapt as neededMonitor capsule and tablet stability studies, refining plans based on findingsPrepare, review, and approve CMC documentation for regulatory submissionsManage and liaise with ESPs performing development and manufacturing tasksReview and archive key documentation from ESPs (e.g., protocols, batch records, reports)Collaborate with Quality & Compliance teams to ensure ESPs adhere to cGMP standardsKeep the Product Specification File up to dateEnsure compliance with internal procedures and procedures and complete mandatory trainingsProvide input for due diligence processes when requested