Johnson & Johnson Careers

Scientist, CRS Project Owner - temporary position

Beerse, Belgium
R&D


Job Description

Requisition ID: 1805628245W

The Clinical Release and Stability (CRS) team is part of Analytical Development in Pharmaceutical Development and Manufacturing Sciences (PDMS). Our department is responsible for:

 

  • Analytical support for Small Molecules Drug Substance (DS) and Drug Product (DP) development
  • Clinical release and stability testing of DS and DP from Phase 1 up to registration 

 
We offer a position for a Scientist in the domain of clinical release and stability, the main responsibilities include: 
 

  • CRS Subject Matter Expert in the Analytical Development sub team where you work together with the AD-SI and other AD functions to translate the project needs in to CRS deliverables such as development, characterization and release testing support.
  • Lead and design stability studies to support product development using both ASAP (accelerated) and more traditional ICH approaches.
  • Collaborate with internal and external CRS laboratories (PHAST, ABT, Eurofins, Wuxi, Catalent…) to ensure full understanding of the analytical data generated.
  • Perform data trending of Stability, Release and analytical process characterization data with advanced visualization tools (Tableau).
  • Scientific evaluation of generated results, profiling of product behavior and discussion with stability experts, the AD-sub team and the DS/DP development teams.
  • Ensure compliance with all relevant regulations, analytical methods and specifications, GMP and safety.




Qualifications

  • You hold a Bachelor, Master or PhD degree in Chemistry, Bio-engineering, or Pharmaceutical Sciences, or equivalent through experience.
  • Good knowledge and experience of analytical techniques required for drug substances and drug product characterization
  • Practical experience in industry is an asset.
  • Good knowledge and practical experience with GMP regulations is an asset.
  • 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
  • You are a team player


What’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
1805628245W