Small Molecule Clinical Release and Stability (CRS) -Project Leader. 12 months Fixed term contract with a possibility of extension. Responsibilities :
Design and coordinate experiments to evaluate the chemical and physical stability of new product
Collaborate closely with internal and external laboratories in Europe, USA and India to ensure right-first-time execution
Provide insights in the long-term stability of drug products using predictive modelling as well as traditional stability testing
Perform data trending with advanced visualization tools (Tableau®)
Represent our group in the cross-functional analytical team where you work together with the analytical project leader and other analytical functions to translate the project needs into deliverables such as development, characterization and release testing support.
Communicate, discuss and report the stability results with stability experts, the cross-functional product team and higher management
Global project coordination as your projects often span offices and time zones.
Manage analytical investigations and deviations
Ensure compliance with all relevant regulations, GMP and safety QualificationsQualifications :
You hold a Master degree in Chemistry, Bio-engineering, or Pharmaceutical Sciences, or equivalent through experience
You have good knowledge and experience of analytical techniques required for drug substances and drug product characterization.
Practical experience in industry is an asset
You can be flexible and adapt quickly to changing business needs
You like to navigate effectively within a large and complex organization
You have good written and verbal communication skills in English language
You can work independently, and you are an enthusiastic team player
Practical experience in industry and knowledge of GMP regulations are an asset
You show a can do mentality and take full ownership of your workThis position is a great starting point to become a project leader in drug development.
You will get a unique look of the different facets of drug development and interact with all key partners / stakeholders needed to take a molecule and develop it into a medicine.
Primary LocationBelgium-Antwerp-Beerse-OrganizationJanssen Pharmaceutica N.V. (7555)Job FunctionR&DRequisition ID2005805218W