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Scientist Clinical Release and Stability - temporary position
Requisition ID: 1805628240W
The Clinical Release and Stability (CRS) team is part of Analytical Development in Pharmaceutical Development and Manufacturing Sciences (PDMS). 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 DP
We offer a Temporary position for a 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 dissolution/Mass spectrometry but other analytical techniques will be trained and applied.
- Perform data evaluation and discuss your results with project team lead.
- Act as subject matter expert for chromatography and/or dissolution for our team and interact with the method development teams to ensure full alignment.
- Act as key person for discussing results of accelerated stability studies with stability experts.
- Coach junior team members and provide training and first line troubleshooting.
- Ensure compliance with all relevant regulations, analytical methods and specifications, GMP and safety.
- You hold a Master degree in Chemistry, Bio-engineering, or Pharmaceutical Sciences, or equivalent through experience. Or a Bachelor degree with 15 years of experience.
- 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 or dissolution 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 and are willing to learn Dutch
- You have good technical writing skills
- You are able to work independently and are also a team player
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.
Janssen Pharmaceutica N.V. (7555)