Senior Scientist Crystallization Expert-00000IW9
Description
The Crystallization Technology Unit (CTU) located in Beerse (Belgium) is part of API (Active Pharmaceutical Ingredient) Small Molecule Development within Janssen. The primary focus of CTU is the development of the final API crystallization and downstream process steps (filtration, drying, milling). Solid form selection, salt screening, scale up and transfer to production are the main responsibilities within the CTU group.
In close collaboration with Drug Product Development, CTU is also responsible for complementary material prerequisites such as particle size distribution range, morphology, bulk density and powder flow behavior. In order to meet these goals CTU relies on a team of experts knowledgeable in different types of crystallization (cooling, evaporative, anti-solvent ?), advanced infrastructure (automated reactors and PAT tools) and a set of supporting key API particle tuning technologies.
The incumbent will be responsible for scientific leadership and project management with respect to crystallization development activities. The primary focus is on late stage projects, ensuring the successful introduction of new processes in the production plant. Integral to the role is the scientific guidance with respect to criticality analysis.
– Provide scientific guidance to CTU staff when developing crystallization processes enabling the timely delivery of API with the required quality attributes, both physical as well as chemical
– Interact with various stakeholders outside the department, such as Pharmaceutical Sciences, Drug Product Development, Commercial API manufacturing sites as well as external partners
– Follow up of ongoing production batches via PAT monitoring
– Troubleshooting of production batches
– Representative for CTU with respect to API control strategy, including spec setting, IPC’s, criticality analysis and process parameters
– Ensure all filing and regulatory information is available and correct
– Drive continuous improvement projects. This can be operational within the CTU group or more technologically oriented in collaboration with the production area
– Lead and participate in local or global technology teams
Qualifications
– You have a PhD degree in Chemistry, Chemical Engineering or Pharmacy
– You are an expert in the use of PAT tools such as Lasentec (FBRM), IR, Raman as well as in the in-depth data interpretation
– You have profound knowledge of existing crystallization technologies and are able to identify new applications
– You have good knowledge of solid state characterization techniques and understand the drivers for form selection
– You have strong interest in project management skills
– You have a clear interest in process chemistry and process technology
– You have good communication skills, written as well as oral, promoting effective interaction with all levels of the organization
– You are a team player able to collaborate with different departments (cross functional)
– You are an innovative and motivated hands-on working Scientist who exhibits a broad analytical aptitude
We offer you a multifaceted challenge in a dynamic, international environment with attractive work conditions and career opportunities as well as good infrastructure. If you are interested in this position, please apply online including application letter, CV and reference letters as appropriate.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-Beerse
Organization: Janssen Pharmaceutica N.V. (7555)
Job Function: R&D
Bron: Senior Scientist Crystallization Expert Job (Beerse, BE)