The Particulates and Container Closure Integrity (PCCI) team is a development lab within the global Janssen Research & Development organization embedded in the GMP environment of the Janssen Supply Chain (JSC). As part of analytical development, we provide end-to-end support working closely with our R&D partners and JSC in an international, dynamic, and diverse team responsible for biotherapeutic products across numerous therapeutic areas such as oncology, immunology, and neuroscience.

To strengthen our team we are seeking a dedicated scientist to coordinate development of particulate assays for early phase programs. In this position, you are responsible for further developing the center of excellence (CoE) for particle counting for biotherapeutic finished products, bridging and coordinating laboratory analytics. Your scientific dedication and agility to work in a GMP-regulated development environment are critical to ensure robust and compliant applications and approaches. After a thorough on-the-job training, you will have responsibility for method development and transfer to the clinical release and stability laboratories with focus on Phase 1 to 2b projects and support of marketed products.

Your Responsibilities:

Assume a leading role in the coordination and development of particulate assays for early phase programs representing the PCCI team and supporting our partner organizations.
Coordinate all laboratory activities pertaining to PCCI particulate base business
Provide technical and scientific expertise to support PCCI base business and investigations
Design experimental plans based on defined results
Represent the PCCI team in project meetings as particle and CCIT subject matter expert
Support development, validation and transfer of particle counting and CCIT methods for aseptic biological products in a GMP regulated environment
Writing scientifically sound technical documents
Compiling data for registration dossier
End-to-end understanding of business processes and ability to propose changes to strive for high efficiency
Highly motivated to work on novel technologies and scouting for new technologies
Work in a team-oriented environment and respect diversity and inclusion when interacting with partners and colleagues

Qualifications - External

For this position we are looking for a scientifically minded, flexible and team-oriented person with the following skills:

Self-employed and entrepreneurial working style
Curiosity and drive to deep-dive into scientific questions
Excellence in analytics, project coordination and presentation skills
Experienced scientist in development or quality control with emphasis on particle counting in a pharmaceutical or other GMP regulated industry preferred.
Knowledge of relevant GMP regulations for analytical laboratories.
Excellent communication skills in English (written and spoken), German desired.
Minimum requirement: MS with 1-2 years' experience in life science, materials, analytical or pharmaceutical sciences.

We are offering you a multifaceted opportunity in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure.

Scientist Analytical Development