Senior Scientist, Particulates Analytics (Biotherapeutics)

Biopharma Asia; Schaffhausen; Hybrid; CHF 100,000 - 140,000; Full time

Benefits offered by this job

Competitive terms

Career opportunities

Good infrastructure

Job summary

Johnson & Johnson in Schaffhausen, Switzerland, seeks a dedicated scientist to advance the Particulates team within GMP-compliant Analytical Development for biotherapeutics. You will coordinate early and late phase programs, develop center of excellence for particle counting, validate methods, support regulatory submissions, and collaborate across R&D and manufacturing.

Strong analytic skills, MS/PhD with experience, and English proficiency required; German desirable; attractive terms in a

Qualifications

• Minimum 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 development
• Self-employed and entrepreneurial style
• Curiosity and drive to deep-dive into scientific questions
• Excellence in analytics, project coordination and presentation skills
• Experience in authoring and reviewing technical content for regulatory submissions advantageous
• 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

Responsibilities

• Assume a leading role in project coordination and method validation of particulate assays for biotherapeutic programs (protein and cell and gene therapy products) representing the Particulates team as subject matter expert (SME)
• Build on existing BSL-2 know-how and infrastructure to expand particle analytical portfolio for cell and gene therapy products
• Coordinate activities pertaining to particle method validations and transfers in compliance with internal guidances and health authority expectations
• Coordinate project-related tasks with our partners
• Represent the particulates 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

Skills

Analytical Reasoning

Biochemistry

Chemistry

Manufacturing

Quality Assurance

CMC

Process Improvements

Regulatory Submissions

English Communication

German (desirable)

Education

M.S. with 5+ years of life science/analytical development experience

PhD with 2+ years of life science/analytical development experience

Job description

Johnson & Johnson in Schaffhausen, Switzerland, seeks a dedicated scientist to advance the Particulates team within GMP-compliant Analytical Development for biotherapeutics. You will coordinate early and late phase programs, develop center of excellence for particle counting, validate methods, support regulatory submissions, and collaborate across R&D and manufacturing.

Strong analytic skills, MS/PhD with experience, and English proficiency required; German desirable; attractive terms in a