Senior Manager, Particulates Analytics & Regulatory

JRNLClub; Schaffhausen; On-site; CHF 180,000 - 240,000; Full time

Job summary

Johnson & Johnson in Schaffhausen seeks a Scientific Senior Manager for Particulates Analytical Development (100%). You will lead the Particulates Analytical Development team overseeing particle analytics for release, characterization and stability testing in a GMP setting.

You translate complex data into regulatory content for global submissions, provide leadership for investigations and lifecycle support, and manage the AD BSL-2 laboratory ensuring compliant operations in a fast-paced

Qualifications

• Proven experience in analytical method development, qualification, validation or transfer for particle counting methods.
• Experience authoring and reviewing regulatory submissions and translating complex analytical data into regulatory narratives.
• Strong technical writing and presentation skills with the ability to lead cross-functional teams.

Responsibilities

• Provide scientific and strategic leadership for particulate matter analytics.
• Lead method development, qualification, validation, transfer, investigation, and lifecycle activities for particulate matter assays.
• Serve as SME for particulate analytics in cross-functional teams and provide scientifically sound recommendations for technical issues.
• Author and review regulatory documents, transfer reports, validation documentation, and responses to health authority questions.
• Coordinate project deliverables and interfaces with R&D, manufacturing, QC labs, and external partners.
• Identify opportunities to strengthen analytics capabilities and evaluate emerging technologies.
• Oversee the AD BSL-2 laboratory and training activities.

Skills

Analytical reasoning

Biochemistry

Chemistry

Manufacturing and Control

Clinical Research and Regulations

Regulatory submissions

Team leadership

Education

Master's degree + 10+ years or PhD + 7+ years

Job description

Johnson & Johnson in Schaffhausen seeks a Scientific Senior Manager for Particulates Analytical Development (100%). You will lead the Particulates Analytical Development team overseeing particle analytics for release, characterization and stability testing in a GMP setting.

You translate complex data into regulatory content for global submissions, provide leadership for investigations and lifecycle support, and manage the AD BSL-2 laboratory ensuring compliant operations in a fast-paced