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The Particulates team is a development laboratory within the global Janssen Research & Development organization and is embedded in the GMP environment of the Johnson & Johnson Innovative Medicine Supply Chain (IMSC). As part of Analytical Development, we provide end-to-end support in close collaboration with our R&D and IMSC partners. Our international, dynamic, and dedicated team supports biotherapeutic products across therapeutic areas including oncology, immunology, and neuroscience.

To strengthen our team we, are seeking a dedicated scientist to represent the team and coordinate early and 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 essential to ensure robust and compliant applications and approaches. After a thorough on-the-job training, you will have responsibility for project coordination, method validations and transfers to manufacturing sites and commercial quality control laboratories, drafting regulatory submissions and supporting marketed products.

Your Responsibilities:

• Assume a leading role in project coordination and method validation of particulate assays for biotherapeutic programs (protein and cell and gene therapy products) representing the Particulates team as subject matter expert (SME).
• Build on existing BSL-2 know-how and infrastructure to expand particle analytical portfolio for cell and gene therapy products
• Coordinate activities pertaining to particle method validations and transfers in compliance with internal guidances and health authority expectations
• Coordinate project-related tasks with our partners
• Represent the particulates team in project meetings as particle subject matter expert (SME)
• 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

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

• Minimum requirement: M.S. with at least 5 years’ experience or PhD with at least 2 years’ experience in life science, material sciences, analytical development or pharmaceutical development
• Self-employed and entrepreneurial style
• Curiosity and drive to deep-dive into scientific questions
• Excellence in analytics, project coordination and presentation skills
• Experience in authoring and reviewing technical content for regulatory submissions advantageous
• Experience within the pharmaceutical or GMP-regulated industry preferred and knowledge of relevant GMP regulations for analytical laboratories
• Excellent communication skills in English (written and spoken), German desired

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

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