Senior Scientist - Particulates (Biotherapeutics)

About the role

The Particulates team is a development laboratory within the global Janssen Research & Development organization, embedded in the GMP environment of the Johnson & Johnson Innovative Medicine Supply Chain. It provides end-to-end analytical support for biotherapeutic products across oncology, immunology and neuroscience. The company is looking for a scientist to coordinate early and late phase programs and to develop the centre of excellence for particle counting of biotherapeutic finished products.

Key responsibilities

• Lead project coordination and method validation of particulate assays for protein, cell and gene therapy products, acting as subject matter expert
• Expand the particle analytical portfolio for cell and gene therapy products using existing BSL-2 know-how and infrastructure
• Coordinate particle method validations and transfers in line with internal guidance and health authority expectations
• Work with partners and represent the team in project meetings
• Write technical documents, compile data for registration dossiers and support regulatory submissions
• After on-the-job training, handle project coordination, method validations and transfers to manufacturing sites and commercial quality control laboratories

Required profile

• M.S. with at least 5 years' experience, or PhD with at least 2 years' experience, in life sciences, material sciences, analytical or pharmaceutical development
• Experience in the pharmaceutical or GMP-regulated industry preferred, with knowledge of relevant GMP regulations for analytical laboratories
• Excellent written and spoken English; German desired

Required skills

• Analytical reasoning, chemistry and CMC
• Project coordination and presentation skills
• Authoring and reviewing technical content for regulatory submissions (advantageous)
• Preferred: drug discovery, molecular diagnostics, quality assurance, process improvements