Senior Scientist, Particulates Analytics (GMP)

Johnson & Johnson Co.; Schweiz; On-site; CHF 90,000 - 130,000; Full time

Job summary

Johnson & Johnson Schaffhausen is seeking a dedicated scientist to coordinate early and late phase programs within the Particulates team of the Janssen R&D organization. You will champion the center of excellence for particle counting in biotherapeutics, bridging analytics with manufacturing and quality control.

You will drive method validations, regulatory submissions, and data compilation for registration dossiers in a GMP environment, collaborating across R&D and IMSC partners to

Qualifications

• Experience in analytical development and regulatory submissions.
• Strong communication and collaboration skills in English; German desired.
• Background in GMP-regulated pharmaceutical environments is advantageous.
• Ability to coordinate complex projects and scientific documentation.

Responsibilities

• Assume a leading role in project coordination and method validation of particulate assays for biotherapeutic programs.
• Build on BSL-2 know-how to expand particle analytical portfolio for cell and gene therapy products.
• Coordinate method validations and transfers with internal guidelines and health authority expectations.
• Represent the team in project meetings as SME and draft regulatory submission documents.
• Compile data for registration dossiers and ensure end-to-end business process understanding.

Skills

Analytical Reasoning

Biochemistry

Chemistry

CMC

Process Improvements

Regulatory Submissions

Communication

Team Collaboration

Scientific Research

Education

M.S. in Life Science

Ph.D. in Life Science

Job description

Johnson & Johnson Schaffhausen is seeking a dedicated scientist to coordinate early and late phase programs within the Particulates team of the Janssen R&D organization. You will champion the center of excellence for particle counting in biotherapeutics, bridging analytics with manufacturing and quality control.

You will drive method validations, regulatory submissions, and data compilation for registration dossiers in a GMP environment, collaborating across R&D and IMSC partners to