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Job Function:
Discovery & Pre-Clinical/Clinical Development
Job Sub Function:
Biotherapeutics R&D
Job Category:
Scientific/Technology
All Job Posting Locations:
Schaffhausen, Switzerland
Job 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 programs. In 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.
Your Responsibilities:
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
Qualifications
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: B.Sc 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 Expression
