Johnson & Johnson Careers
Scientist, CRS Project Owner (temp)
Requisition ID: 1805669220W
‘Caring for the world, one person at a time’… inspires and unites the people of Johnson & Johnson. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people.
Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Janssen Pharmaceutica joined the Johnson & Johnson group in 1961. Today, Janssen Pharmaceutica is one of the most innovative pharmaceutical companies in the world.
Janssen Research & Development
Worldwide, Janssen R&D focuses on five domains: neuroscience, cardiovascular diseases and metabolism, infectious diseases, immunology and oncology. Within these areas, the focus is on the research and development of vaccines, small and large molecules. Our campus in Beerse, Belgium, is the largest R&D center within the entire Janssen group focusing in the discovery of small and large molecules.
It is the engine behind the continuous innovation at Janssen. In this campus, we invest over 1 billion euros each year in R&D!
Researchers and laboratory workers with different nationalities work together on a daily basis to improve and innovate. The know-how on our campus – one of the leading R&D centers in the Janssen group and beyond – is also continually growing.
We offer our (Senior) Scientists a platform to work with the best and most experience people in their scientific field.
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 SME in the AD-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 Master 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…?
“Caring for the world, one person at a time…”
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-university, 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)