Drug Product Expert
Contracting – Walloon Brabant
Responsibilities:
- Expert in clinical DP development accountable for leading and running assigned project work packages, ranging from clinical formulation orientation work for FIH study up to commercial registration and launch for the development pipeline and as part of the life cycle management of commercial brands.
- Contribute to project sub-team (DS, DP or analytical) as 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, planning, 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 & priorities.
- Act as key enabler supporting the advancement of Pharma Science’s Science & Technology and Innovation projects by leveraging own area of expertise to lead functional initiatives and contribute to PS transversal initiatives.
Profile:
- Master’s degree in biology, pharmacology, biomedical sciences, biotechnology, or a related field.
Essential criteria:
- Strong knowledge of pharmaceutical product development, formulation, and processes (background in engineering or pharmacy, but not purely in pharmacy)
- Proficiency in techniques such as hot-melt extrusion with twin-screw granulation
- Specific technical skills can be developed, so expertise is not a strict requirement
- We are looking for a proactive individual, able to collaborate effectively, and highly motivated
Preferred criteria:
- Practical experience, especially in formulation development or working with powders/tablets (the more independent the candidate, the better)
- Knowledge of techniques like tableting, coating, or modeling
- Experience with FDA standards or experience in the pharmaceutical industry
Languages:
- Fluency in both English and French is ideal, but proficiency in one of the two is a plus. Only speaking English is acceptable.
Our Offer
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way.
