Preformulation Scientist (small molecules) - Belgium
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- Physical chemical characterization of NCEs (developability assessment, optimization & selection of drug candidates)
- Development of safe and biopharmaceutical suitable non-clinical formulations for in vivo Pharmacology, Toxicology and Pharmacokinetics studies
- Development of in-house clinical formulation, process and manufacturing development starting from FIH until successful validation (stage 1 & stage 2) at commercial scale
- Life cycle management, process/formulation improvements, and troubleshooting support
- The incumbent will support NCEs Non-Clinical programs managing all quality, scientific and technical aspects of Non-clinical formulation activities. More specifically, you will conduct:
- Physical chemical evaluation of NCE's;
- Screening for the identification of the best formulation approach(es) for accelerated, standard and enabling clinical formulations and the development of Non-clinical formulations;
- Physical chemical characterization of non-clinical formulations (e.g. Chromatographic Analysis, DSC, TGA, PSD analysis, microscopy, rheology…etc.); In this context, you will
- Contribute to the definition, organization, coordination and check of Non-clinical formulation activities.
- Develop, adjust and apply physical chemical and analytical methods to the characterization of NCEs.
- Develop non-clinical formulations for GLP and non-GLP Safety Pharmacology, Toxicology and Pharmacokinetics studies.
- Contribute to the identification of the best formulation approach(es) for accelerated, standard and enabling clinical formulations.
- Take part in the writing of study reports.
- Do calibrations and other verifications in accordance with procedures and reference documents in collaboration with and as defined by the Site Metrology Unit.
- Follow the working and safety procedures.
- Control the supply of products, reagents and small equipment.
- Participate to the guarantee of the compliance of Preformulation & Non-clinical Formulations with the OECD principles of Good Laboratory Practices.
- Participate to the Quality Control of the non clinical formulations in order to allow the achievement of non clinical studies while assuring the quality required at the level of the realized studies and the respect of the schedules and priorities.
- You will be working in a communicative and dynamic environment with a flat hierarchy, where you can support the program and projects with your initiative. Besides this, the position offers opportunities to work in multidisciplinary and international teams.
- Master degree in Pharmaceutical Sciences or equivalent;
- 1-3 years’ professional with a focus on formulation development of poorly soluble compounds, preferably applied to Non-clinical development including a scientific expertise and operational background in analytics and characterization methods.
- Communication, influencing and negotiation skills in English and French languages to represent the department internally and externally.
- Demonstrated ability in documentation and coordination in tracking activities.
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