Scientist

• Lead strategic and operational CMC regulatory activities across product development, clinical submissions, registrations, and lifecycle management
• Drive global CMC strategies for clinical trial applications, new product licenses, and post-approval changes
• Assess CMC, facility/equipment, and plasma-related changes and manage regulatory submissions with regional teams
• Serve as primary regulatory liaison with technical experts and support GMP inspections and inspection readiness
• Interpret regulatory guidelines and requirements, prepare impact assessments, and contribute to process improvements
• Provide technical guidance to the organization
• Maintain relevant parts of regulatory dossiers
• Prepare, revise, and review Module 2.3, Module 3, facility and equipment information, and related documents for registrations and lifecycle submissions
• Author dossier narratives and other regulatory CMC documentation
• Provide responses to CMC-related Health Authority questions
• Compile and review CMC information for CTAs, INDs, Scientific Advice Meetings, Briefing Books, and IBs
• Support regulatory assessments and execution of CMC changes
• Prepare and review CMC information for tenders, PSURs, DSURs, CCDS/product information, and promotional materials
• Contribute to annual product quality reviews and risk assessments
• Participate in Regulatory Affairs Strategy Teams and relevant CMC Regulatory Sub-Teams
• Represent Global Regulatory Affairs in CMC project teams
• Develop and implement global CMC regulatory strategies
• Interface with technical expert departments for project planning, technical documentation, and CMC regulatory questions
• Evaluate technical and scientific CMC information, perform gap analyses, and propose risk-remediation strategies
• Support scheduling and prioritization of CMC-related submissions

GRA CMC Scientist

• Serve as a bioprocessing domain expert for biotechnology and biopharmaceutical customers
• Support downstream bioprocessing workflows and provide technical leadership throughout the customer journey
• Troubleshoot complex process challenges and quality or performance issues
• Conduct demonstrations, proof-of-principle studies, pilot runs, and technology qualification
• Deliver technical training for customers and internal colleagues
• Conduct workflow consulting and GEMBA walks to identify process improvement opportunities
• Support Bioprocessing Development Center activities and on-site demonstrations
• Develop customer adoption plans and monitor implementation success through measurable milestones
• Maintain customer engagement records, opportunity tracking, and technical documentation in Salesforce.com
• Collaborate with Account Managers, Product Management, R&D, Manufacturing, Quality, Regulatory, and Field Service teams
• Gather and communicate Voice of Customer insights for product roadmap development and best-practice documentation
• Represent Thermo Fisher Scientific at conferences, workshops, webinars, and industry events through technical presentations and thought leadership

Scientist jobs in Switzerland

GRA CMC Scientist

Downstream Field Application Scientist