Overview
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.
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Job Details
Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Biotherapeutics R&D
Job Category: Scientific/Technology
Location: 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 products—building 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.
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)
* Write scientifically sound technical documents
* Compile data for registration dossiers
* Demonstrate end-to-end understanding of business processes and propose changes to improve efficiency
* Be 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
* 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
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