Sr. Scientist Biologics AD

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 Job Function: Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function: Biotherapeutics R&DJob Category:Scientific/TechnologyAll Job Posting Locations:Schaffhausen, SwitzerlandJob Description:Sr. Scientist (m/f/d)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 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 and container closure integrity testing (CCIT) for products in the cell and gene therapy space, building up, growing, and coordinating laboratory analytics for particle and CCI 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 and CCIT assays for cell and gene therapy programs representing the PCCI team and supporting our partner organizations.Build on existing BSL-2 know-how and infrastructure to expand particle and CCIT analytical portfolio for cell and gene therapy productsCoordinate activities pertaining to PCCI particle and CCIT method validations and transfers in compliance with internal guidances and health authority expectationsCoordinate all project-related tasks with our partnersRepresent the PCCI team in project meetings as particle and CCIT subject matter expertWriting scientifically sound technical documentsCompiling data for registration dossierEnd-to-end understanding of business processes and ability to propose changes to strive for high efficiencyHighly motivated to work on novel technologies and scouting for new technologiesWork in a team-oriented environment and respect diversity and inclusion when interacting with partners and colleaguesQualificationsFor this position we are looking for a scientifically minded, flexible and team-oriented person with the following skills:Self-employed and entrepreneurial styleCuriosity and drive to deep-dive into scientific questionsExcellence in analytics, project coordination and presentation skillsBackground in cell and gene therapy analytics (e.g., CAR-T, LVV, AAV and oncolytic viruses) advantageousExperience within the pharmaceutical or GMP-regulated industry preferred and knowledge of relevant GMP regulations for analytical laboratoriesExcellent communication skills in English (written and spoken), German desiredMinimum 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 developmentWe are offering you a multifaceted opportunity in a dynamic, international environment with attractive terms and career opportunities as well as a good infrastructureRequired Skills: GMP Environments, Good Manufacturing Practices (GMP), IndependencePreferred Skills:Curious Mindset