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Scientist, CRS Project Owner - temporary position
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
- 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.
- 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
Janssen Pharmaceutica N.V. (7555)