Principle Scientist
Johnson & Johnson
Beerse, Belgium
2 dagen geleden

Principle Scientist Predictive Analytics and Stability Sciences

Johnson & Johnson is the world's most comprehensive and broadly-based manufacturer of health care products, pharmaceuticals, and medical devices.

The Janssen Pharmaceutical Companies of Johnson & Johnson conduct research and development in a variety of therapeutic areas to discover novel therapeutic approaches to address unmet medical conditions.

Janssen has a rich portfolio of small and large molecules, as well as vaccines, driven by strong science and innovation.

The Janssen campus in Beerse (Belgium) hosts 5,000 employees. It has a unique ecosystem covering the complete drug development life cycle, with all capabilities from basic science to market access on one campus.

The integrated environment of the campus provides employees a unique chance to experience many different aspects of drug development throughout their careers.

It has a successful track record of over sixty years of drug discovery and development, and it is one of the most important innovation engines of the Janssen group worldwide.

The Center of Excellence for Predictive Analytics and Stability Sciences (CoE PASS) is a team of scientists within the Analytical Development organization of Janssen Pharmaceutica R&D that focuses on the use of accelerated studies and predictive models to assess drug stability.

Within Janssen Pharmaceutica, the expertise of the CoE PASS is drawn upon throughout the various stages of the drug lifecycle, ranging from the late discovery phase, over the full drug development cycle, and all the way up to the commercialization stage of the product.

In the discovery stage, the CoE PASS supports the selection process of a New Molecular Entity (NME) by providing early hydrolytic and oxidative stability warnings by combining experimental design and calculations.

During the early drug development stage, the CoE PASS conducts forced degradation studies, excipient compatibility studies, and mechanistic investigations to determine the drug chemistry of the product and to assess the physical and chemical stability of a drug substance in combination with its excipients.

To support the formulation selection during development, short-term accelerated chemical and physical stability studies are performed, and for the final formulation, the CoE PASS applies predictive models to assess the long-term stability profile of a drug, using risk-based predictive stability approaches.

On a global level, the CoE PASS is an active contributor and participant in several international consortia that aim to define a cross-industry standard on new stability approaches that are acceptable to regulatory authorities.

The team has a long-standing tradition, and a track record of successful collaborations with universities and research institutes worldwide on fundamental research in the area of stability and predictive stability.

Furthermore, the CoE PASS is now exploring opportunities to expand its scope and develop new predictive models that could accelerate the speed of drug development and improve the overall quality of the final drug.

Position summary :

  • The successful candidate will design and lead accelerated stability studies to support drug product development and investigations from pre-NME to the late developmental phase.
  • S)he will apply current and novel predictive models to support specification and shelf-life setting of drug products, and identify suitable packaging configurations.

    S)he will lead a strategy for predictive excipient compatibility using current experimental data and in-silico assessment.

  • In collaboration with internal and external partners, (s)he will explore the application of predictive and statistical models for dissolution changes and changes in other physical parameters such as solid-state on stability.
  • S)he will work in a multidisciplinary matrix environment and will act as a scientific coach to younger scientists within a broader team.

  • The successful candidate will lead and represent the CoE PASS in cross-functional workgroups that are set-up to optimize current ways of working and stay abreast with state-of-the-art scientific knowledge to ensure innovative and high-quality stability evaluation.
  • Furthermore, the successful candidate will contribute to the CoE PASS team effort to develop new predictive models to accelerate drug development and improve the overall quality of the final drug product.
  • Qualifications

    Overall Qualifications

  • Ph.D. in pharmaceutical sciences, chemical engineering, physical chemistry, organic chemistry or equivalent interdisciplinary training in related fields
  • Plus 3 years’ experience in the pharmaceutical industry or other relevant industry
  • Experience or keen interest in modeling and statistics
  • Experience and Skills

  • Firm knowledge of pharmaceutical dosage forms and solid-state sciences
  • Knowledge of pharmaceutical drug product formulation development
  • Knowledge on accelerated stability testing is a plus
  • Experience with common analysis tools like R, Octave or Matlab is a plus
  • Knowledge of analytical techniques and organic chemistry is a plus
  • Demonstrated creativity and innovation in problem-solving
  • Experience in working in matrix teams
  • Excellent oral and written communication skills, fluent in English both verbal and in writing
  • Good soft skills, willing to challenge the status quo in a constructive manner suggesting alternative solutions for existing problems
  • Ability to build bridges between colleagues, disciplines, departments, and collaborators
  • Customer-oriented and results-driven
  • Efficient, flexible and dynamic
  • Our offer

    An exciting position in an international and dynamic environment with continuous learning and growth opportunities

    An attractive remuneration package with additional benefit packages (for example hospital insurance, and other health care incentives if applicable)

    An inclusive team environment where diversity and different opinions are respected and valued, and the importance of a good work-life balance is recognized

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