Associate Scientist CRS

Job Description

The Clinical Release and Stability (CRS) team is part of Analytical Development in Small Molecule Pharmaceutical Development Our department is responsible for:• Clinical release and stability testing of Drug Substance (DS) and Drug Product (DP) for small molecules from Phase 1 up to registration • Manufacturing and characterization development support for DS and DPWe offer a position for an associate scientist in the domain of clinical release and stability, the main responsibilities include: • Perform analysis in support of product characterization, release and stability. • Main focus will be on mass spectrometry but other analytical techniques will be trained and applied.• Perform data evaluation and discuss your results with project lead.• Act as key person for, and coach junior team members in executing Pharmacy Manual Qualification studies and accelerated stability studies• Ensure compliance with all relevant regulations, analytical methods and specifications, GMP and safety.
Qualifications
• You hold a Master degree in Chemistry, Bio-engineering, or Pharmaceutical Sciences• Good knowledge and experience of analytical techniques required for drug substances and drug product characterization (LC/MS, Dissolution, ...). • Practical experience in pharmaceutical Industry with chromatography and dissolution is required• Practical experience in Pharmacy Manual Qualification studies is required• Good knowledge and practical experience with GMP regulations is required• Ensure high scientific quality standards for experiments and ownership of work • You are efficient, flexible and dynamic. You show a “Can do mentality”• You have innovative solutions/problem solving skills • You are customer-oriented and results-driven• You have good knowledge of the English language, both spoken and written• You have good technical writing skills• You are able to work independently and are also a team playerWhat’s in it for you ...?As an employee, we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment, your development is key and our day-to-day responsibility. Through e-learning, on the job training, various projects and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future.
Primary Location
Belgium-Antwerp-Beerse-
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
R&D
Requisition ID
1905780300W