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 senior scientist to represent the team and coordinate late 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 validations and transfers to the commercial quality control laboratories, drafting regulatory submissions and supporting marketed products.
• Assume a leading role in project coordination and validation of particulate assays for late phase programs representing the PCCI team and supporting our partner organizations.
• Coordinate activities pertaining to PCCI particle method validations and transfers in compliance with internal guidances and health authority expectations
• Coordinate all project-related tasks with our partners
• 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
For this position we are looking for a scientifically minded, flexible and team-oriented person with the following skills:
• Self-employed and entrepreneurial 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 GMPregulated industry preferred
• Knowledge of relevant GMP regulations for analytical laboratories
• Excellent communication skills in English (written and spoken), German desired
• Minimum requirement: M.S. with at least 10 years’ experience or PhD with at least 5 years' experience in life science, material sciences, analytical development or pharmaceutical development
We are offering you a multifaceted opportunity in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructure.