description du poste

To join a multinational biopharmaceutical company, we are looking for a Senior expert in Clinical Drug Product development accountable for leading and running assigned project work packages, ranging from clinical formulation orientation work for First In Human study up to commercial registration and launch for the development pipeline and as part of the life cycle management of commercial brands. The position is based in Walloon Brabant. This a consultant position also open to freelancers.• Contribute to project sub-team (DS, DP or analytical) as senior SME representing own area of expertise and actively contributing to the elaboration of project strategy.• To drive development (internal or external) of innovative formulations and manufacturing processes for the supply of bulk clinical trial material for development pipeline projects• To identify scientifically the best formulation and process for accelerated, standard and enabling clinical formulations by designing, planing, performing, interpreting and reporting results of experiments in time to influence strategic project decisions and recommend next steps.• To ensure process robustness, validation and transfer of NCEs and Lifecycle management of mature product manufacturing process and technologies to commercial launch site.• To perform clinical formulation orientation work in collaboration with Non-Clinical Formulation Lead to transition the project from Product Material Orientation (PMO) team to DP dev. team. Accountability is on the clinical DP expert side, however close interaction with the NCL formulation lead is expected.• Manage CLO/CRO/CMO activities, including selection, negotiation and implementation of appropriate agreements in cooperation with Outsourcing representative.• Contribute to setting and delivering departmental goals prioritiesProfile:Master or PhD in pharmaceutical sciences or relevant specialty with at least 5 years’ experience in formulation and/or process development for new pharmaceutical product development. Experience with oral dosage forms for small molecules highly desired.Competencies:Problem Solving : Use scientific expertise to design technical experiments independently/autonomously in order to resolve complex problems. Proven ability to critically interpret results, build new experimental hypotheses, and take calculated risks and smart decisionsDemonstrated ability to collaborate effectively across teams within and beyond own departmentSignificant project management abilities needed to coordinate/manage activities internally/externally and to forecast resources and timelinesUp to date knowledge of GMP and regulatory requirements within area of expertiseExcellent communication and presentation skills with the ability to convey information in a clear and concise manner to write clear instructions, protocol and reportsFluent in EnglishInterested please send your CV to karin.opdecamp@hays.com or call Karin +32 498 17 67 47 for more information.