Scientific Senior Manager, Particulates Analytical Development

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Job Function:
Discovery & Pre-Clinical/Clinical Development

Job Sub Function:
Biotherapeutics R&D

Job Category:
People Leader

All Job Posting Locations:
Schaffhausen, Switzerland

Job Description:

We are offering an outstanding opportunity for a

Scientific Senior Manager, Particulates Analytical Development (100%)

In this position, you will assume a leading role in the Particulates Analytical Development team in Schaffhausen.

The team provides end-to-end support for large-molecule projects, including particle analytical procedures for release, characterization and stability testing of drug products,associated devices and combination products.

You will apply scientific curiosity and analytical excellence to develop robust, phase-appropriate and compliant approaches in a GMP-regulated environment.

A key responsibility will be translating scientific data and analytical strategies into clear technically rigorous content for global regulatory submissions.

You will provide scientific and operational leadership for investigation and complaint testing, site and QC laboratory support and lifecycle support while influencing cross-functional decisions and advancing the team's analytical capabilities.

You will also oversee the AD BSL-2 laboratory and associated training activities.

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Responsibilities:


* Provide scientific and strategic leadership for particulate matter analytics



* Define phase-appropriate analytical strategies for visible and subvisible particulate matter and ensure alignment with product development needs, internal standards, and global health authority expectations

• Lead and oversee method development, qualification, validation, transfer, investigation, and lifecycle activities for particulate matter assays, including planning, execution, documentation, and review


* Serve as SME for particulate analytics in cross-functional teams and provide scientifically sound recommendations for technical issues



* Author and critically review high-quality technical and regulatory documents, including analytical transfer reports, validation documentation, responses to health authority questions, and relevant sect...