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Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Biotherapeutics R&DJob Category:
Scientific/TechnologyAll Job Posting Locations:
Schaffhausen SwitzerlandJob Description:
Scientist (m/f/d)
The Particle team is a development lab within the global Janssen Research & Development organization 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 working closely with our R&D partners and IMSC in an international dynamic and dedicated 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 represent the team and coordinate early and late phase this position you are responsible for further developing the center of excellence (CoE) for particle counting for productsbuilding up growing and coordinating laboratory analytics for particle testing. 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.
Assume a leading role in project coordination and validation of particulate assays for cell and gene therapy programs representing the team and supporting our partner organizations.
Coordinate activities pertaining to particle method validations and transfers in compliance with internal guidances and health authority expectations
Coordinate all project-related tasks with our partners
Represent the 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
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
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
Minimum requirement: with at least 3 years experience or Master 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!
Required Skills:
Preferred Skills:
Analytical Reasoning Biochemistry Chemistry Manufacturing and Control (CMC) Clinical Trial Protocols Collaborating Data Quality Drug Discovery Development Execution Focus Molecular Diagnostics Pharmacogenetics Problem Solving Research Documents Scientific Research Technologically Savvy Troubleshooting Written ExpressionRequired Experience:
IC
About Johnson & Johnson A t Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s larges ... View more